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					  The official opinion of NB-Med is expressed exclusively in Consensus Statements and
  NB-Med Recommendations that appear in the respective folder in CIRCA. Any other documents
  are working drafts or individual opinions which may have not been agreed by the NB-Med Group.


EUROPEAN COMMISSION
DG ENTERPRISE
Directorate G                                                                      NBM/071/05
Unit 4 - Pressure Equipment, Medical Devices, Metrology

                          MEDICAL DEVICES : Guidance document




                                                                  MEDDEV 2.12-1 rev 5

                                                                         Avril 2005




                                         GUIDELINES

                      ON A MEDICAL DEVICES VIGILANCE SYSTEM




The present Guidelines are part of a set of Guidelines relating to questions of application of
EC-Directives on medical devices. They are legally not binding. The Guidelines have been
carefully drafted through a process of intensive consultation of the various interested parties
(competent authorities, Commission services, industries, other interested parties) during
which intermediate drafts were circulated and comments were taken up in the document.
Therefore, this document reflects positions taken by representatives of interested parties in
the medical devices sector.

Note :         This document is a revision of an earlier document published in April 2001 as
               MEDDEV 2.12/1 - rev. 4




                                                                                             1
Table of Contents

1) Foreword (basis on the current commisson website)

2) Introduction to the vigilance system)
 Vigilance System (current section 1,2 and 3: consolidated proposal
     from DK with support of IR, Eucomed and UK))

3) Scope (to whom it applies)
 General principles (old section 4)

4) Definitions

5) Manufacturers’ Role

5.1 Incident/Near Incidents reporting system

          sources of the report
          what to report
          when to
          to whom
          how to report 

5.1.1 Investigation (including decission making process regarding corrective actions)

5.1.2 Communication

       content of initial, follow, final and trend reports

5.2 safety related (?) field corrective actions

          sources of the report
          what to report
          when to
          to whom
          how to report 

5.2.1. information about close out

5.2.2.content of the advisory

6) Responsibility of the CA

6.1 Incident/Near Incidents reporting system

       - actions on a report of users or from other systems (e.g GHTF, literature)
       - action on a report of an mfr
       - risk evaluation
       - co-ordination between CAs
       - information of interest parties
       - safeguard clause
       - information about closure

6.2 safety related (?) field corrective actions


                                                                                        2
       -   administrative actions on a report
       -   evaluation of mfr rationale
       -   evaluation of information provided by mfr
       -   co-ordination between CAs
       -   information about closure
       -   information of interest parties
       -   safeguard clause

6.3 coordination between CAs and information exchange

7) Role of the Notified Body

8) Roll of the user

9) Roll of European Commission




                                                        3
1 Foreword

Review section 1 -3 two after decisions of definition.

These Guidelines on the Medical Device Vigilance System are part of a set of Medical
Device Guidelines that promote a common approach by Manufacturers and Notified Bodies
involved in the conformity assessment procedures according to the relevant annexes of the
Directives, and by the Competent Authorities charged with safeguarding Public Health.

They have been carefully drafted through a process of consultation with various interested
parties during which intermediate drafts were circulated and comments were taken up in the
documents. Therefore, it reflect positions taken in particular by representatives of Competent
Authorities and Commission Services, Notified Bodies, industry and other interested parties
in the medical devices sector.
The Guidelines are regularly updated to keep them up to date with regulatory developments.
The latest version of the Guidelines should always be used. This revision of these Guidelines
has:
   carefully considered and transposed into the European context the Global Harmonisation
    Task Force (GHTF) international regulatory guidance documents on vigilance and post
    market surveillance SG2 N9R11, SG2 N20R10, SG2 N21R8, SG2 N31R8, SG2 N32R5,
    SG2 N33R11, SG2 N36R7 (see Appendix ? for references)
   addressed the introduction of European medical device database Eudamed
   (introduced an index and simplified and reordered the document to make it easier for
    readers to navigate to and use relevant parts of the Guidance)
   ammended the document in light of experience with previous clauses.

These guidelines are not legally binding. It is recognised that under given circumstances, for
example, as a result of scientific developments, an alternative approach may be possible or
appropriate to comply with the legal requirements.

Nevertheless, due to the participation of the aforementioned interested parties and of experts
from Competent Authorities, it is anticipated that the Guidelines will be followed within the
Member States and, therefore, ensure uniform application of relevant Directive provisions.


2 Introduction

The principal purpose of the Medical Device Vigilance System is to improve the protection of
health and safety of patients, users and others by reducing the likelihood of reoccurrence of
the incident elsewhere. This is to be achieved by the evaluation of reported incidents and,
where appropriate, dissemination of information, which could be used to prevent such
repetitions, or to alleviate the consequences of such incidents.

The Vigilance system is intended to facilitate a direct and early implementation of corrective
action across borders where the device is in use, in contrast to action taken on a country by
country basis. Reconsider this sentence after discussing safety field corrective action item.
Corrective action includes, but may not be confined to: device recall; issue of advisory notice;
additional surveillance/modification of devices in use; modification to future device design,
components or manufacturing process; modification to labelling or instructions for use.




                                                                                                 4
Reconsider this sentence after discussing safety field corrective action item. These
Guidelines describe the European System for the notification and evaluation of adverse
incidents and recalls involving medical devices, known as the Medical Device Vigilance
System.

These Guidelines are intended to facilitate the uniform application and implementation of the
Medical Device Vigilance System requirements contained within:
 the Directive for Active Implantable Medical Devices (AIMD), 90/385/EEC
 the Directive for Medical Devices (MDD), 93/42/EEC
 the In Vitro Diagnostic Medical Devices Directive (IVDD), 98/79/EC.

IR to incorporate a statement that vigilance is a part of the post production phase


3 Scope
These Guidelines describe in order the requirements of the Medical Device Vigilance system
as it applies to:
   Manufacturers1
   Competent Authorities
   the European Commission
   Notified Bodies (to reconsider following the discussion on NBs direct involvement within
    vigilance scheme), HR to make a proposal about NBs role in the vigilance scheme
    (section 7)
   Users and others concerned with the continuing safety of medical devices

These Guidelines cover the actions to be taken once the Manufacturer or Competent
Authority receives information concerning an adverse incident involving a medical device.
Information on incidents which should be reported under the Vigilance System may come to
the attention of Manufacturers via the systematic procedure to review experience gained
from devices in the post-production phase, or by other means (see Annexes II, IV, V, VI, VII
of MDD and Annexes III, IV, VI and VII of IVDD). The term "post-marketing surveillance" as
referred to in Annexes 2, 4, 5 in AIMD has the same meaning as the aforementioned
"systematic procedure".

These Guidelines cover Article 8 (AIMD), Article 10 (MDD) and Article 11 (IVDD) outlining the
obligations of Member States upon the receipt of incident reports, from Manufacturers or
other sources, concerning any medical device which carries the CE marking. They also
include guidance to Competent Authorities about the issue and receipt of information from
National Competent Authorities outside Europe who are involved in the GHTF NCAR
exchange programme.

These Guidelines are relevant to incidents occurring within the Member States of the
European Community and all other States within the European Economic Area (EEA) with
regard to:
   devices which carry the CE-mark
   devices which do not carry the CE-mark, where such incidents lead to corrective action
    relevant to CE-marked devices.


1
 including their authorised representatives and persons responsible for placing on
the market, see Definitions.


                                                                                               5
These Guideline cover field safety ( Eucomed) corrective action relevant to CE-marked
devices which are offered for sale or are in use within the EEA.(remark by UK: agreement
depends on the definition of field safety corrective action).
These Guidelines do not apply to devices under pre-marketing clinical investigation or
performance evaluation.

These Guidelines make no recommendations on

The structure of the systems by which Manufacturers gather information concerning the use
of devices in the post-production phase, of which the viligance system is an integral part, is
outside the scope of this document.

Include drug device combinations (IR). To whom to report adverse events of drug device combination
(Eucomed) at appropriate place.


3.1     General principles

Reference to the appropriate sections of the doc
Consider section 4 for deletion after going through the whole document and
identifying doublettes.

3.1.1    For Manufacturers

     The Manufacturer has the responsibility investigating adverse incidents and for taking
      any corrective action necessary.
     The Manufacturer or their Authorised Representative should submit an initial incident
      report to the Competent Authority for recording and evaluation. Each initial report should
      lead to a final report unless they are combined. But not every incident report will lead to a
      corrective action. Move to body ??
     The Manufacturer or their Authorised Representative should notify the relevant CA about
      safety field corrective action. (see section 5.3.1)
     The Manufacturer should ensure that these Guidelines are made known to their
      authorised representatives within the EEA, persons responsible for placing devices on
      the market and any other agents authorised to act on their behalf for purposes related to
      Medical Devices Vigilance, so that the Manufacturers' responsibilities may be fulfilled.
     The Manufacturer should ensure that their authorised representative within the EEA,
      persons responsible for placing devices on the market and any other agents authorised
      to act on their behalf for purposes relating to Medical Devices Vigilance, are kept
      informed of incident reports as appropriate.
     The Manufacturer should consider informing official distributors etc as appropriate during
      the procedure. This does not affect the right of the Manufacturer to determine the person
      authorised to be the principle contact point for purposes of relating to Medical Devices
      Vigilance. (consider for deletion in the second round)
     Where an incident or near incident occurs as a consequence of the combined use of two
      or more separate devices (and/or accessories) made by different Manufacturers, each
      Manufacturer should submit a report to the relevant Competent Authority (see section
      5.1)
     It is recommended that Manufacturers keep the NB advised of vigilance issues occuring
      in the post production phase affecting the certification. (see section 5 and 7 for further
      clarification)(TS to wait for NBOG document)




                                                                                                     6
The act of reporting an incident to a Competent Authority is not to be construed as an
admission of liability for the incident and its consequences. Written reports may carry a
disclaimer to this effect.

For a complete description of the Manufacturer’s role in the Vigilance System, see part XX of
these Guidelines.


3.1.2   For Competent Authorities
For the purposes of Medical Devices Vigilance, Member States are represented by
appointed Competent Authorities, their vigilance contact points are listed on the European
Commission web site (link).

    The Competent Authority monitors the investigation of the incident carried out by the
     Manufacturer.
    The Competent Authority should take any further action that may be necessary to
     supplement the actions of the Manufacturer.
    Competent Authorities may also monitor experience with devices of the same kind (for
     instance, all defibrillators or all syringes), but made by different Manufacturers. They may
     then be able to take measures applicable to all devices of that kind. This could include,
     for example, initiating user education or suggesting re-classification. To be deleted (PT
     and Eucomed)
    Member States should ensure that organisations and individuals involved in purchasing
     medical devices and in the provision of health-care are aware that their co-operation is
     vital in providing the first link in the Vigilance chain. This includes organisations and
     individuals responsible for providing calibration and maintenance for medical devices.
    Depending on the outcome to the investigation, any information necessary for the
     prevention of further incidents (or the limitation of their consequences) should be
     disseminated by the Competent Authority.
    In order to enhance the efficacy of the Medical Device Vigilance system, Competent
     Authorities should encourage the reporting of adverse incidents by the user and other
     professionals involved in the distribution, the delivery or putting in to service of the
     device. Such reports may be made directly to the Manufacturer or to the Competent
     Authority as well depending on National practice.

Information held by Competent Authorities in connection with the Vigilance System is to be
held in confidence, as defined by the relevant Articles of the Directives2. However, any
incident report should be available on request, and in confidence, to the other European
Competent Authorities and to other National Competent Authorities participating with the
GHTF exchange programme.

For a complete description of the Competent Authority’s role in the Vigilance System, see
part 6 of this Guideline.


3.1.3   For Users

    Users should report incidents with medical devices to the Manufacturer or to the
     Competent Authority as well depending on National practice.
    Once corrective (or other) action is identified, hospital administrators, medical
     practitioners and other health-care professionals, and user representatives responsible

2
    AIMD 15, MDD 20 and IVDD 20


                                                                                                7
      for the maintenance and the safety of medical devices, can take the necessary steps.
      Such steps should, where practicable, be taken in co-operation with the Manufacturer.

For a complete description of the user’s role in the Vigilance System, see part XX of this
Guideline.


4 Definitions

(the placement of this section needs to be discussed)



4.1     Incident / Adverse Event

“Any malfunction, failure or deterioration in the characteristics and/or performance of a
device, as well as any inadequacy in the labelling or the instructions for use which, directly or
indirectly, might lead to or might have led to the death of a patient, or user or of other
persons or to a serious deterioration in their state of health.”



4.2     Field Safety Notice

A communication to customer sent out by a manufacturer or its representative in relation with
a Field Safety Corrective Action.

(take care in 5.2 to whom this goes)


4.3     Field Safety Corrective Action (FSCA)

A field safety corrective action taken by a manufacturer to prevent or reduce a risk of death
or serious deterioration in the state of health associated with the use of a medical device.
Such actions should be notified via a field safety notice.

In assessing the need of the FSCA the mfr is advised to use the methodology described in
the harmonised standard EN ISO 14971 last edition.

This may include

-     the return of a medical device to the supplier;
-     device modification;
-     device exchange;
-     device destruction;
-     retrofit by purchaser of manufacturer's modification or design change;
-     advice given by mfr regarding the use of the device (e.g. where the device is no longer on
      the market or has been withdrawn but could still possibly be in use e.g. implants)


A device modifications can include:
- permanent or temporary changes to the labelling or instructions for use;
- software upgrades including those carried out be remote access;


                                                                                                8
-     modification to the clinical management of patients to address a risk of serious injury or
      death related specifically to the characteristics of the device. For example:
          - For implantable devices it is often clinically unjustifiable to explant the device.
             Corrective action taking the form of special patient follow-up, irrespective of
             whether any affected un-implanted devices remain available for return, constitutes
             recall action.
          - For any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of
             patients for retesting or the retest or review of previous results constitutes recall
             action.
-     advice on a change in the way the device is used e.g. IVDS manufacturer advises
      revised quality control procedure -use of third party controls or more frequent calibration.


Footnote: make a link to article 10 SECOND part




4.4     Authorised Representative

Ludger Möller pls ckeck this definition!

Any natural or legal person established in the Community who, explicitly designated by the
Manufacturer, acts and may be addressed by authorities and bodies in the Community
instead of the Manufacturer with regard to latter’s obligations under the Directive.



4.5     Drug / Device Combination Product

A medical device incorporating a medicinal product or substance where the action of the
medicinal product or substance is ancillary to that of the device. In this case, the lead
Directive is the Medical Devices Directive or Active Implantable Medical Device Directive,
respectively. Products, which fall into this category, are subject to either the medical device
requirements, or medicinal product requirements or to both.



4.6     EUDAMED
The European database for Medical Devices EUDAMED is to centralise data on:
 manufacturers and their authorised representatives,
 devices placed on the Community market,
 certificates issued, suspended or withdrawn and
 the vigilance procedure.


ALL: Decide what of the following definition is to be taken

“Foreseeable misuse” is when the product is used in a way which is not intended by the
manufacturer. Manufacturers are required to anticipate the real world uses of their products
and are responsible for “foreseeable misuse” by the consumer. Foreseeable misuse includes
foreseeable product alterations by the consumer. A manufacturer must also warn a
consumer of dangers associated with product misuse. Note that foreseeable misuse that is



                                                                                                  9
warned against in the instruction for use is considered abnormal use if all other reasonable
means of risk control have been exhausted. (NO from Internet)



4.7   REASONABLY FORESEEABLE MISUSE

use by the OPERATOR in a way not intended by the MANUFACTURER but which can result
from readily predictable human behaviour

NOTE 1 REASONABLY FORESEEABLE MISUSE is an intended action.

NOTE 2 Use refers to a product, PROCESS or service.

NOTE 3 Slips, lapses, mistakes and ABNORMAL USE can also be reasonably foreseeable,
but are not considered (take out note 3 (UK))

[ISO/IEC Guide 51:1999, definition 3.14, modified]

Decide about the definition in line with the discussion of the appropriate part

IEC 60601-1-6 usability + IEC 62366 draft revision to be provided by CFW



4.8   Intended Purpose (Ref. Article 1.2 (g) of MDD)
.... means the use for which the device is intended according to the data supplied by the
manufacturer on the labelling, in the instructions and/or in promotional materials...



4.9   Manufacturer
The natural or legal person with responsibility for the design, manufacture, packaging and
labelling of a device before it is placed on the market under his own name, regardless of
whether these operations are carried out by that person himself or on his behalf by a third
party. (Art. 1 and 2f of the MDD)



4.10 Medical Device
For the purpose of the Medical Devices Directives 90/385/EEC, 93/42/EEC and 98/79/EEC,
any instrument, apparatus, appliance, material or other Article, whether used alone or in
combination, including the software necessary for its proper application intended by the
Manufacturer to be used for human beings for the purpose of:

 -    diagnosis, prevention, monitoring, treatment or alleviation of disease,
 -    diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
      handicap,
 -    investigation, replacement or modification of the anatomy or of a
      physiological process,
 -    control of conception,




                                                                                               10
  and which does not achieve its principal intended action in or on the human body by
  pharmacological, immunological or metabolic means, but which may be assisted in its
  function by such means.



4.11 Near incident
(depends on the discussion of time line whether incorporated or not)


4.12 Periodic Summary Reporting
An alternative reporting regime to individual incident reporting, that may be agreed between
manufacturers and Competent Authorities. Summary reports are submitted in an agreed
format and frequency for certain types of device and adverse incident.

Note: There is a standard format for trend and periodic summary reports see Annex 3 (to be
created).


4.13 Serious public health threat (GHTF SG2 N33R11)
Any event type, which results in imminent risk of death, serious injury, or serious illness
that may require prompt remedial action.


4.14 Single fault condition (EN IEC 60601-1)
Condition in which a single means for protection against hazards is defective or a single
external abnormal hazardous condition is present (see Clause 12). ???



4.15 Trend Reporting (see GHTF N36)
An alternative reporting type to individual incident reporting used when a significant increase
or trend in adverse incident reports occurs. Pre-defined trigger levels are used to determine
the threshold for reporting.

See also GHTF WG2 document N36 'Manufacturer's Trend reporting of Adverse Incidents'
provides useful guidance.' Note: There is a standard format for trend and periodic summary
reports (to be created).


4.16 User
The health care institution, professional, carer or patient using or maintaining medical
devices.



5 Manufacturers´Role

5.1   Incident/Near Incident reporting system




                                                                                              11
As a general principle, there should be a pre-disposition to report rather than not to report in
case of doubt on the reportability of an incident.

Reference to the following considerations may be made in the report, or should be kept on
file by the manufacturer in the case of a decision not to report.

Incidents which occur outside the EEA and do not lead to a safety field corrective action do
not need to be reported within the frame of this guidline.

Where appropriate, manufacturers should notify their authorised representative, persons
responsible for placing on the market and any other agents authorised to act on their behalf
of incidents and FSCA reported under the Vigilance System.

If the manufacturer is located outside the EEA, a suitable contact point within the EEA should
be provided. This may be the manufacturer's authorised representative, persons responsible
for placing devices on the market or any other agent authorised to act on their behalf for
purposes relating to Medical Devices Vigilance.

Any report should not be unduly delayed because of incomplete information.



5.1.1    Criteria for INCIDENTS TO BE REPORTED BY MANUFACTURERS TO
         COMPETENT AUTHORITIES

Any event which meets all three basic reporting criteria A – C listed below is considered as
an incident/adverse event and should be reported to the relevant Competent Authority. The
criteria are that:


A: An event (or potential event) has occurred

This also includes situations where testing performed on the device, examination of the
information supplied with the device or any scientific information indicates some factor that
could lead or has lead to an event. Reference to the following considerations may be made
in the report, or should be kept on file by the manufacturer in the case of a decision not to
report.


Typical events are:

a) A malfunction or deterioration in the characteristics or performance.
      A malfunction or deterioration should be understood as a failure of a device to
      perform in accordance with its intended purpose when used in accordance with the
      manufacturer's instructions.

        The intended purpose means the use for which the device is intended according to
        the data supplied by the manufacturer on the labeling, in the instructions and/or in
        promotional materials.

b) An inadequate design or manufacture.
      This would include cases where the design or manufacturing of a device is found
      deficient.

c) An inaccuracy in the labeling, instructions for use and/or promotional materials.


                                                                                                12
      Inaccuracies include omissions and deficiencies.
      Omissions do not include the absence of information that should generally be
      known by the intended users.


e) Other information becoming available.
      This can include results of testing performed by the manufacturer on its products,
      or by the user prior to being used on the patient, or by other parties.
      This can also include information from the literature or other scientific
      documentation.


B: The manufacturer’s device is suspected to be a contributory cause of the incident

In assessing the link between the device and the incident or near incident, the manufacturer
should take account of:

   the opinion, based on available evidence, of health-care professionals;
   the results of the manufacturer's own preliminary assessment of the incident;
   evidence of previous, similar incidents;
   other evidence held by the manufacturer.

This judgement may be difficult when there are multiple devices and drugs involved. In
complex situations, it should be assumed that the device was associated with the
event.



C: The event led, or might have led, to one of the following outcomes:
           death of a patient, user or other person
           serious deterioration in state of health of a patient, user or other person.


               A serious deterioration in state of health can include:

                  a) life-threatening illness or injury;
                  b) permanent impairment of a body function or permanent damage to a
                     body structure;
                  c) a condition necessitating medical or surgical intervention to
                     prevent a) or b)


           o   a significant increase in the duration of a surgical procedure
           o   a condition that requires hospitalisation or significant prolongation of
               existing hospitalisation
           o   any unnecessary treatment or medical intervention taken as a
               consequence of an incorrect diagnostic result when used within mfr
               instructions for use
           o   fetal distress, fetal death or any congenital abnormality or birth defects


E: A significant public health concern.

      This can include an event that is of significant and unexpected nature such that it
      becomes alarming as a potential public health hazard, e.g. human immunodeficiency


                                                                                            13
        virus (HIV) or Creutzfeldt-Jacob Disease (CJD). These concerns may be identified by
        either the NCA or the manufacturer.



5.1.2    Incidents which might have led to death or serious deterioration in health.

Not all incidents which should be reported involve a death or serious deterioration in health
which actually occurred. The non-occurrence of such a result might have been due to other
fortunate circumstances or to the intervention of health-care personnel.

It is sufficient that:

an incident associated with a device happened, and
the incident was such that, if it occurred again, it might lead to death or serious deterioration
in health.

OR

testing or examination of the device or the information supplied with the device, or any
scientific literature indicated some factor (eg a deterioration in characteristics or
performance, or a shortcoming in the information) which could lead to an incident involving
death or serious deterioration in health.

For the purposes of these Guidelines, such potential incidents are to be known as "near
incidents".

For a near incident to be reported, a possible direct link with the device, or with shortcomings
in the information supplied, should be clearly established.

DE no need for distinguishing incident/near incident since the only consequence might be timeline
Delete the previous 2 paras


Certain incidents may be exempt from reporting if any one of the criteria described in
paragraph 5.1.4 is applicable.


5.1.3    WHEN SUMMARY REPORTING IS ALLOWED UNDER THE VIGILANCE SYSTEM

There are a number of occasions when a Competent Authority may accept from a
manufacturer or authorised representative periodic summary or trend reports, rather than
individual reports of incidents. These are:

Incidents described in a Field safety notice

Incidents specified in the field safety notice that occur after the manufacturer has issued a
field safety notice need not be reported individually. The manufacturer should provide a
periodic summary report, the content, and frequency of which should be agreed with the
relevant Competent Authority.

Example:




                                                                                                    14
Manufacturer issued a field safety notice and conducted a field safety corrective
action of a coronary stent that migrated due to inadequate inflation of an attached
balloon mechanism. Subsequent examples of stent migration were summarised in
quarterly reports concerning the field safety corrective action and individual incidents
did not have to be reported.


Summary reporting granted by the Competent Authority.

Common and well-documented incidents may be exempted from reporting individually by
the Competent Authority and changed to periodic summary reporting. In such circumstances
the content, frequency should be agreed with the relevant Competent Authority.
Interim report should be made whenever trigger levels are exceeded. Trigger levels for
interim reporting should also be agreed with the Competent Authority.


The agreed format for periodic summary reports is given at Section XX




5.1.4   CONDITIONS WHERE REPORTING UNDER THE VIGILANCE SYSTEM IS NOT

5.1.4   REQUIRED

If a manufacturer and/or their authorised representative have effective systems in place for
monitoring adverse incident trends and have determined suitable trigger levels for trend
reporting for 5.1.4.5 and 5.1.4.6 then there are some specific conditions when the
submission of an adverse incident is not usually required under the vigilance system. These
conditions are given in 5.1.5 below.

However, these exemptions from reporting should not be used for incidents that:

       involve particular issues of significant public health threat or concern as determined
        by the relevant Competent Authority
       incidents that have reached or exceeded an established trending trigger level




5.1.4.1 Deficiency of a device found by the user prior to its use.

Regardless of the existence of provisions in the instruction for use provided by the
manufacturer, deficiencies of devices that are always detected (that could not go
undetected) by the user and where no serious injury has occurred, do not need to be
reported.

Examples:

       User performs an inflation test prior to inserting the balloon catheter in the
        patientas required in the instructions for use accompanying the device.
        Malfunction on inflation is identified. Another balloon is used. Patient is not




                                                                                             15
       injured.

      Sterile single use device packaging is labeled with the caution ‘do not use if
       package is opened or damaged’. Open package seals are discovered prior to
       use,device is not used.

      Intravenous administration set tip protector has fallen off the set during
       distribution resulting in a non-sterile fluid pathway. The intravenous
       administration set was not used.


5.1.4.2 Adverse incident caused by patient conditions.

When the manufacturer has information that the root cause of the adverse incident is due to
patient condition, the incident does not need to be reported. These conditions could be pre-
existing or occurring during device use.

To justify no report, the manufacturer should have information available to conclude that the
device performed as intended and did not cause or contribute to death or serious injury. A
person qualified to make a medical judgement would accept the same conclusion.

Examples:

      Orthopaedic surgeon implants a hip joint and warns against sports-related use.
       Patient chooses to go water skiing and subsequently requires premature
       revision due to not following directions.

      Early revision of an orthopedic implant due to loosening caused by the patient
       developing osteolysis, which is not considered a direct consequence of the implant
       failure. This conclusion would need to be supported by the opinion of a medical expert.

      A patient died after dialysis treatment. The patient had end-stage-renal disease
       and died of renal failure.


5.1.4.3 Service life or shelf-life of the medical device.

When the only cause for the adverse incident was that the device exceeded its service life or
shelf-life as specified by the manufacturer and the failure mode is not unusual, the adverse
incident does not need to be reported.

The service life or shelf-life must be specified by the device manufacturer and included in the
master record [technical file] or, where appropriate, the instructions for use (IFU). Service life
or shelf-life is defined as: the time or usage that a device is intended to remain functional
after it is manufactured, placed into use, and maintained as specified. Reporting assessment
shall be based on the information in the master record or in IFU.

Examples:

      Loss of sensing after a pacemaker has reached end of life. Elective
       replacement indicator has shown up in due time according to device
       specification. Surgical explantation of pacemaker required.




                                                                                               16
      A drill bit was used beyond end of specified life. It fractured during invasive
       operation. Operation time was prolonged due to the difficulty to retrieve the
       broken parts.

5.1.4.4 Protection against a fault functioned correctly.

Incidents which did not lead to serious injury or death (near incidents), because a design
feature protected against a fault becoming a hazard (in accordance with relevant standards
or documented design inputs), do not need to be reported. If an alarm system is used, the
concept of this system should be generally acknowledged for that type of product and there
must be no danger for the patient as a precondition to omit reporting.


Examples:

      An infusion pump stops, due to a malfunction, but gives an appropriate alarm
       (e.g. in compliance with relevant standards) and there was no injury to the
       patient.

      Microprocessor-controlled radiant warmers malfunction and provide an audible
       appropriate alarm. (e.g., in compliance with relevant standards) and there was
       no injury to the patient.

      During radiation treatment, the automatic exposure control is engaged.
       Treatment stops. Although patient receives less than optimal dose, patient is
       not exposed to excess radiation.

5.1.4.5 Negligible likelihood of occurrence of death or serious injury.

Near incidents where the risk of a death or serious injury has been quantified and found to be
negligibly small need not be reported if no incident has occurred and the risk has been
characterised and documented as acceptable within a full risk assessment.

If an incident resulting in death or serious injury has happened, the incident is reportable and
a reassessment of the risk is necessary. If reassessment determines that the risk remains
negligible, previous reports of near incidents of the same type do not need to be reported
retrospectively. Decisions not to report subsequent failures of the same type must be
documented. Changes in the trend, usually an increase, of these non-serious outcomes must
be reported.

Example:

          Manufacturer of pacemaker released on the market identified a software bug
           and quantified the probability of occurrence of a serious injury with a
           particular setting to be negligibly small. No patients experienced adverse
           health effects.


5.1.4.6 Expected and foreseeable side effects.


Expected and foreseeable side effects which meet all the following criteria:

      clearly identified in the manufacturer's labelling;



                                                                                             17
       clinically well known* as being foreseeable and having a certain qualitative** and
        quantitative predictability when the device is used and performs as intended;
       documented in the device master record, with an appropriate risk assessment, prior
        to the occurrence of the adverse event; and
       clinically acceptable in terms of the patient benefit.

are ordinarily not reportable.

    NOTES:

* Some of these events are well known in the medical, scientific, or technology field; others
may have been clearly identified during clinical investigation or clinical practice and labeled
by the manufacturer.

** The conditions that lead to the side effect can be described but they may sometimes be
difficult to predict numerically

Conversely, side effects which were not documented and foreseeable, or which were not
acceptable in terms of individual patient benefit should continue to be reported.

Examples of adverse events that do not normally need to be reported:

       A patient who is known to suffer from claustrophobia experiences severe anxiety in
        the confined space of a MRI machine which subsequently led to the patient being
        injured. Potential for claustrophobia is known and documented in the device product
        information.

       A patient receives a second-degree burn during the use in an emergency of an
        external defibrillator. Risk assessment documents that such a burn has been
        accepted in view of potential patient benefit and is warned in the instructions for use.
        The frequency of burns is occurring within range specified in the device master
        record.

       A patient has an undesirable tissue reaction (e.g. nickel allergy) previously known
        and documented in the device product information.

       Patient who has a mechanical heart valve developed endocarditis ten years after
        implantation and then died. Risk assessment documents that endocarditis at this
        stage is clinically acceptable in view of patient benefit and the the instructions for use
        warn of this this potential side effect.

       Placement of central line catheter results in anxiety reaction and shortness of breath.
        Both reactions are known and labeled side effects.

EDMA will provide an example for IVDs


5.1.5   Trend reports


On identifying a significant increase or trend of event that are excluded from individual reporting as per
§ 5.1.4.5 and 5.1.4.6 a report may need to be made to the relevant Competent Authority. To enable
this all manufacturers should have suitable systems in place for proactive scrutiny of trends in all
complaints and adverse events occurring with their devices. GHTF SG2 document N36
'Manufacturer's Trend reporting of Adverse Incidents' provides useful guidance.


                                                                                                       18
A trend report to the Competent Authority where the manufacture or Authorised Representative has its
registered place of business should be made where there is a significant increase in the rate of:

       already reportable events
       adverse events that are usually exempt from reporting
       adverse events scheduled for periodic summary reporting (PSR)*,

irrespective of whether reporting exemptions apply or periodic summary reporting has been agreed.


(Note: PSR reporting might be a fruitful area for concerted European action
? an Annexe to the MEDDEV with agreed PSR areas?)




5.1.6   TIMESCALE FOR THE INITIAL REPORTING OF AN INCIDENT OR NEAR
        INCIDENT

: Discussion postponed until Miguel Antunes can present the results of his second
enquiry

The report should be made as soon as possible. The timing should be commensurate with
determining whether the incident falls within the guidance discussed above. The times given below are
the maximum elapsed times for determining the relevant facts and making an initial report.

The time runs from the manufacturer first being informed of the incident, to the relevant Competent
Authority receiving the notification from the manufacturer.

        Any serious public health threat whether incident or near incident - 48 hours
        Incidents 10 days
        Near incidents 30 days

        Eucomed: use SG2 N33


    -   Incidents (and near incidents): As soon as possible, but not later than 30 days following the
        date of awareness of the event. Incidents that result in unanticipated death or unanticipated
        serious injury or represent a serious public health threat or an imminent danger must be
        reported immediately. (like GHTF SG2,) (DE)

    -   Recalls as well as incidents occurring in countries outside the EEA and which result in
        corrective action: At the latest when the implementation of the corrective measure is started.
        (DE)


        Any serious public health threat whether incident or near incident - 48 hours
        Incidents 10 days
        Near incidents 30 days
        AGREE! (PT)

        Eucomed: use SG2 N33

By law/ordinance:

FR +BE+ DK without delay



                                                                                                        19
CZ 1to 3days
Slovenia 3days
DE max 30 days depending on the risk
HU 8 days
LT 3
NO without delay
CH 10 and 30

Way to solve: if the mfr is aware that the criteria are fulfilled => report immediately; otherwise mfr has
no more than XX days to find the link and needs to report at the latest at that day independend the
criteria are fulfilled. The XX days will be linked to the risk associated with the incident. If the no-link
situation can not be established, report.

UWG: PT, EUcomed, DE,BE, UK to make a new draft for the timeline


     -    Incidents (and near incidents): As soon as possible, but not later than 30 days following the
          date of awareness of the event. Incidents that result in unanticipated death or unanticipated
          serious injury or represent a serious public health threat or an imminent danger must be
          reported immediately. (like GHTF SG2,) (DE)

     -    FSCA: At the latest when the implementation of the corrective measure is started. (DE)


ALTERNATIVE provided by EUCOMED

General statement ;

Directive MDD 92/42.EC

“Any malfunction of deterioration in the characteristics and / or performance of a
device…..which might lead or might have led to the death of a patient of or user or to a serious
deterioration in state of health.”

(Based on the above.)

If there is evidence that a malfunction of a device contributed to a death or serious injury, or
might have done so, the manufacturer should report immediately on the date on which this
information is obtained.
-----------------------------------------------------------------------------------------
In order to investigate, the manufacturer is given (from the date of being informed of the
event):

-    10 calendar days maximum if the adverse event resulted in unanticipated death, or
     unanticipated serious injury or represents a serious public health care threat. In case of
     doubt regarding a possible causal relationhip at the end of this investigation time, the
     manufacturer should report.


-    30 calendar days maximum for all other reportable events. In case of doubt regarding a
     possible causal relationhip at the end of this investigation time, the manufacturer should
     report.

-----------------------------------------------------------------------------------------
Definitions (extracted from GHTF SG2 N 33)




                                                                                                          20
5.1.7    To whom to report

In general, the report should be made to the Competent Authority in the country of
occurrence of the incident.



5.1.8    ACCESS TO THE DEVICE SUSPECTED TO BE INVOLVED IN THE INCIDENT


Access to the device suspected of involvement in an incident

5.6.1 A manufacturer may consult with the user on a particular incident before a report has been made
to the Competent Authority (see paragraph 6.1). The manufacturer may also wish to have access to
the device suspected to have contributed to the incident for the purpose of deciding whether the
incident should be reported to the Competent Authority. The mfr may request support from the
Competent Authorities to gain access to the device so that testing can be performed as soon as
possible. Any delay can result in loss of evidence (e.g loss of short term memory data stored in the
device software; degradation of certain devices when exposed to blood…) rendering future analysis of
the root cause impossible.


If the manufacturer gains access to the device, and his initial assessment (or cleaning or
decontamination process) will involve altering the device in a way which may affect subsequent
analysis, then the manufacturer should inform the Competent Authority before proceeding. The
Competent Authority may then consider whether to intervene. Due to the frequency of these requests
a statement introduced in the Initial Vigilance report should cover this requirement. e.g “ Unless the
CA opposes to a destructive analysis being done on this device, the manufacturer may begin such
analysis 10 days following issuance of this Initial Vigilance report.”

NOTE: This section also applies to samples and any other useful information associated with the
incident.

END OF DAY 5




5.2     Investigations

The manufacturer normally performs the investigation, while the Competent Authority
monitors progress. Timeframe(s) for follow up and/or final reports should be defined.

If the manufacturer is not able to perform the investigation of an incident then he should
inform the Competent Authority without delay.

The Competent Authority may intervene, or initiate independent investigation if appropriate.
This should be in consultation with the manufacturer where practicable.

It is possible that the action concerning an incident may be completed without further
investigation following the initial report.

For drug device combination products regulated under the medical device directives, the CA
receiving the vigilance report should establish a link with any other relevant national CA, if
required.




                                                                                                     21
Note: The above principles are generalised and do not take account of interventions by
judicial or other agencies.




5.2.1    Details to be included in manufacturer reports

Appendix 3 comprises the essential details of an adverse incident to be included in any report
made by a manufacturer, supplier or authorised representative to a Competent Authority.

The list is derived from work produced by the Global Harmonisation Task Force, Study
Group 2, Document N32: Medical Device Post-Market Vigilance & Surveillance – Universal
Data Set for Manufacturer Adverse Event Reports.

If the initial report is made by means other than by letter post or fax (eg telephone, e-mail), it
should be followed as soon as possible by a written confirmation.

The report may also include a statement to the effect that the report is made by the
manufacturer without prejudice and does not imply any admission of liability for the incident
or its consequences.



5.3     Field Safety Corrective Action

The Directives require any technical or medical reason for the systematic recall of a device to
be notified by the manufacturer to a Competent Authority. The Term "withdrawal" used in the
AIMD is interpreted in the same way. This Guideline uses the definition of a Safety Field
Corrective Action as a synonym for recall since there is no longer a harmonised definition of
recall.

Removals from the market for purely commercial non safety related reasons are not
included.

FSCA taken on a basis of incidents occurred outside the EEA and affect CE-marked devices
are covered by this guideline.

A simplified flow chart illustrating the types of recalls to be reported is given at Appendix 6.
(to be checked after redraft)

EUCOMED volunteers to make a proposal. Use safety field corrective action FSCA.


5.3.1    Notification to Competent Authorities

Isabel to clarify with Commission Service whether safety corrective actions that were not
performed in the field are reportable to the CA (e.g. internal production changes, material
changes etc)

The manufacturer should issue a notification to the Competent Authorities of all countries
affected (see below), using the format recommended in Annex 3 (Revised 6.2?? Note i.e. -
based on GHTF SG2 N32 but modified to encompass recall reports) and the CA responsible
for the mfr or AR.



                                                                                                   22
This notification should include all relevant documents necessary for the Competent
Authority to monitor the FSCA, e.g.
    relevant parts from the risk analysis
    clear description of the problem and all facts necessary for the improvement of the
       action
    affected devices and serial number range
    in the case of an action concerning lots or parts of lots a explanation why the other
       devices are not affected
    the action itself and the explanation for their effectiveness.

Manufacturers should also include a copy of the Field Safety Notice to the Competent
Authorities along with the notification. This should be done before or at the same time as
FSCA is being issued.

It is recommended to inform the CAs which CA has been consulted on the draft of the FSN.

It is recommended to copy the FSN to NB responsible for the device, if appropriate.



5.3.2   Content of the FSN


By following the recommendations below the clarity of Field Safety Notices will be improved.
This will reduce the likelihood of CAs either requesting manufacturers issue revised FSN or
issuing separate CA communication.

It is recommended that Manufacturers should provide a draft of the FSN to a relevant
Competent Authority, e.g where the mfr or the AR has his registered place of business,
where most of the affected devices are on the market or any other appropriate CA. Normally,
the mfr should allow a minimum of 48 hours for receipt of comment on the Advisory Notice
unless the nature of the recall dictates a shorter timescale e.g. for serious public health
threat.

Unless duly justified by local situation, a uniform and consistent FSN should be offered by
the mfr to all affected EEA countries.


The Field Safety Notice should be on company letterhead, be written in the language
accepted by the CA and include the following:

1. A clear title, with 'Urgent Medical Device Safety Field Corrective Action' followed by the
   commercial name of the affected product, an FSCA-identifier (e.g. date) and the type of
   action (e.g. chapter 4 definition of a FSCA).

Still to be clarified whether a international symbol could be used (DE)

2. Specific details to enable the affected product to be easily identified e.g. model name and
   number, batch numbers of affected devices and part or order number.

3. A factual statement explaining the reasons for the FSCA, including description of the
   device deficiency or malfunction, clarification of the potential hazard associated with the




                                                                                              23
      continued use of the device and the associated risk to the patient, user or other person.

4. Advice on actions to be taken by the user.
   Include as appropriate:
        identifying and quarantining the device,
        method of recovery, disposal or modification of device
        recommended patient follow up, e.g implants, IVD
        timelines.

5. A request to pass the advisory notice to all those who need to be aware of it within the
   organisation and to maintain awareness over an appropriate defined period.

6. If relevant, a request for the details of any affected devices that have been transferred to
   other organisations, to be given to the manufacturer and for a copy of the advisory notice
   to be passed on to the organisation to which the device has been transferred.

7. If relevant a request that the recipient of the advisory notice alerts other organisations to
   which incorrect test results from the use of the devices have been sent. For example
   failure of diagnostic tests.

8. Confirmation that the relevant Competent Authorities have been advised of the recall.

9. Any comments and descriptions that attempt to,

      a) serve to play down the level of risk in an inappropriate manner
      b) advertise products or services

      should be omitted.

10. Contact point for customers how and when to reach the designated person.


The mfr should inform all concerned Competent Authorities once the action has been completed.

NOTE: EDMA and EUCOMED will come up with a proposal of a template.



5.4     OUTCOME OF AN INVESTIGATION, AND FOLLOW-UP


5.4.1    PRINCIPLES

Normally, the manufacturer should take the action necessary following the investigation,
including consultation with the Competent Authority and performing any FSCA - see
paragraph 5.4.2.

The Competent Authority may take any further action it deems appropriate, consulting with
the manufacturer where possible - see paragraph 6.X.


5.4.2    Follow-up Report




                                                                                                24
The manufacturer should provide a follow-up-report to the Competent Authority if the
investigation time achieves the time line given to the Competent Authority within the Initial
Report.


5.4.3   Final report

There should be a final report which is a written statement of the outcome of the investigation
and of any action. This is made by the manufacturer to the Competent Authority. If the
Competent Authority performs the investigation then the manufacturer should be informed of
the result. A suggested format for the manufacturer's final report is in Appendix 3.



5.4.4   MANUFACTURER ACTIONS

The manufacturer should make a final report to the relevant Competent Authority - see also
paragraphs 8.3 and 8.6. A suggested format for the manufacturer's final report is in Appendix
3.

8.2.2 Outcomes may include, for example:

   no action;
   additional surveillance or follow-up of devices in use;
   dissemination of information to users, eg by advisory notice;
   preventive (EUCOMED) action on future production;
   corrective action on devices in use;
   recall.

8.2.3 notification of the relevant CAs about the devices on the market in case of
corrective actions taken by mfr (HU)




6 Responsibilities of COMPETENT AUTHORITY

Andrea, Phillipe and Irene to provide a draft about CA Communication to public


The Competent Authority should acknowledge the receipt of the report to the sender.

The Competent Authority should evaluate the report in consultation with the manufacturer if
practicable (see para 7), advise as appropriate and intervene if necessary ,.


   The Competent Authority should take any further action that may be necessary to
    supplement the actions of the Manufacturer.

   Member States should ensure that organisations and individuals involved in purchasing
    medical devices and in the provision of health-care are aware that their co-operation is
    vital in providing the first link in the Vigilance chain. This includes organisations and



                                                                                                25
      individuals responsible for providing calibration and maintenance for medical devices.

     Depending on the outcome to the investigation, any information necessary for the
      prevention of further incidents (or the limitation of their consequences) should be
      disseminated by the Competent Authority.

     In order to enhance the efficacy of the Medical Device Vigilance system, Competent
      Authorities should encourage the reporting of adverse incidents by the user and other
      professionals involved in the distribution, the delivery or putting in to service of the
      device. Such reports may be made directly to the Manufacturer or to the Competent
      Authority as well depending on National practice.

Bullet point 2-4 to be rearranged and moved into the new Information Section (Andrea et al)


6.1     Actions on a report from users or other systems

A report which appears to meet the criteria of para 5.1.1 and 5.1.2, received by a Competent
Authority from a User Reporting system or other source, should be copied by the Competent
Authority to the manufacturer without delay or translation. In doing so, patient confidentiality
should be maintained.

Once the manufacturer has been so informed, the subsequent procedure is the same, as far
as practicable, as that described in Section 5 of these Guidelines.

ES to check whether handling of the user reports submitted from CA to mfr is addressed in
this document:

Request of:      1) Follow up report if the incident is reportable according to mfr opinion
                 2) send a justification with the reasons why not a reportable event.




6.2     Evaluation of the vigilance report and monitoring subsequent actions


The Competent Authority normally monitors the investigation being carried out by the
manufacturer. However, the Competent Authority may intervene at any time. Such
intervention should be in consultation with the manufacturer where practicable.

Aspects of the manufacturer's investigation which may be monitored include, for example:

     course, or direction the investigation is taking;
     conduct, or how the investigation is being carried out;
     progress, or how quickly the investigation is being carried out;
     outcome, or whether the results are satisfactory.

Facts which may be needed include, for example:

     the number of devices involved;
     the length of time they have been on the market;
     details of design changes which have been made.



                                                                                                 26
Liaison may be needed with:

     Notified Bodies (involved in the attestation leading to the CE marking);
     users;
     other Competent Authorities;
     other independent bodies, test houses etc.

The Competent Authority should consider liaison with other (non-medical device) Competent
Authorities, for example if a medicinal product is involved.

The Competent Authority should take coordinating action to ensure that an investigation is
carried out if several manufacturers are involved.

Competent Authorities may also monitor experience with the use of devices of the same kind
(for instance, all defibrillators or all syringes), but made by different manufacturers. They may
then be able to take measures applicable to all devices of that kind. This could include, for
example, initiating user education or suggesting re-classification

Proposal of TS about actions of CA on a final report supported by ES

The CA should inform the manufacturer about the closure of the case. (appropriate section
??separate section ???)

END of Day 7

6.3     CO-ORDINATION BETWEEN COMPETENT AUTHORITIES

7.2.1 Initial reports are not normally disseminated between Competent Authorities. In the
case of initial reports which confirm that incidents meet the criteria set out in paragraph 8.4.1,
information should be disseminated between Competent Authorities of the countries where
the device has been sold (EUROM VI) and to the Commission at this stage (see paragraph
8.4)3. In the unusual incident that an initial report is to be disseminated, the Competent
Authority should inform the manufacturer prior to issue.

However, in order to achieve the purpose of the Vigilance system, any report made by a
manufacturer to an individual Competent Authority should be accessible in confidence to the
other Competent Authorities on request.

ES: delete, no CA will routinely disseminate reports. Eudamed´s second phase is contra this section.


6.3.1    Determination of the coordinating Competent Authority

Competent Authorities may determine a single coordinating Competent Authority under the
following circumstances:

     incidents of similar types occurring in more than one country within the EEA;
     FSCA conducted in more than one country within the EEA, whether or not a reportable
      incident has occurred.



3
 Other dissemination obligations may exist under the Mutual Recognition Agreements (MRAs).
Further guidance will be provided.


                                                                                                   27
The following hierarchy should determine the co-ordinating Competent Authority, unless
otherwise agreed between Competent Authorities:

     the Competent Authority which has a particular high interest in consulting other CAs and
      therefore initiates the co-ordination
     the Competent Authority in the State where the manufacturer or his authorised
      representative is situated.
     the Competent Authority in the State where the Notified Body which made the attestation
      leading to CE-marking, is situated.



6.3.2    The tasks of the coordinating Competent Authority

The coordinating Competent Authority has responsibility for should:

     monitor the investigation and coordinate the contacts with the manufacturer on behalf of
      other Competent Authorities;
     access the expertise of the relevant Notified Body and coordinate with other Competent
      Authorities within the EEA;
     discuss with the manufacturer the principles, need and circumstances of corrective
      actions to be taken within the EEA;
     disseminate details of incidents which meet the criteria set out in paragraph 5.1.2 to
      other Competent Authorities and the Commission, including confirming the names of
      other States affected by FSCA etc. receiving and pooling data and experience from other
      Competent Authorities.
     Find agreements with mfr and amongst CAs about implementing in all affected European
      countries (Eucomed, DK (?))


7.2.4 Confirmation of a co-ordinating Competent Authority where applicable should be
provided on the Competent Authority Report (see paragraph 8.4.2) under "reason for report"
(see Appendix 8).

ES: as this CA may act not only in cases of FSCA, the restriction of NCAR makes no sense.
FSCA will be notified to all affected CAs.

Such an arrangement would not affect the rights of an individual Competent Authority to
perform its own monitoring or investigation, or to instigate action within its Member State in
accordance with the provisions of the relevant Directives.

ES: This provision, which no CA will give up, destroys the para about coordinating CA. We
need a principle discussion what may be covered here.


7.3      COMMITTEE ON MEDICAL DEVICES delete (DK)

If similar reports are being investigated in different Member States, it is recommended that
the Commission should be informed, so that it can facilitate or support measures such as
those described above. At the initiative of the Commission or the Member State, the matter
may be discussed in the framework of the Committee on Medical Devices (Article 6 of AIMD,
Article 7 of MDD and Article 7 of IVDD).




                                                                                                 28
Section 8 has been moved to 5.3.X

8.3      COMPETENT AUTHORITY ACTIONS


8.3.2 Competent Authority actions should be in consultation with the manufacturer wherever
practicable. This covers Competent Authority Reports as well.


8.3.3 The Competent Authority should consider the content and method of dissemination of
any advisory notice, in consultation with the manufacturer and medical practitioner if
appropriate - see paragraph 8.5.

8.3.4 Other Competent Authority actions may include, for example: (do we need this ?? ES
during preparation)

     no action;
     gathering more information, for example by commissioning independent reports;
     making recommendations to manufacturers, for example to improve information provided
      with the device;
     keeping the Commission and other Competent Authorities informed, for example on
      recalls and other actions to be taken; the information may be in the format of a
      Competent Authority Report (see paragraph 8.4.2), or similar;
     consulting with the relevant Notified Body on matters relating to the conformity
      assessment;
     consulting the Commission, for example if it is considered that re-classification of the
      device is necessary;
     further user education;
     further recommendations to users;
     any other action to supplement manufacturer action.

8.3.5 The Competent Authority may take action in accordance with Article 2 of either
Directive, or in accordance with Article 7 of the AIMD, Article 8 of the MDD or Article 11 of
the IVDD. (Inform the other CAs about this (HU); comment ES during prep: isn´t it
already covered by 8.4 ??)

8.3.6 The Competent Authority should consider whether action needs to be taken on similar
devices, made by (from instead of made by EUCOMED) the same or a different
manufacturer.

This is in my opinion already covered by 6.2 previous last para. ES


6.4     DISSEMINATION OF INFORMATION BETWEEN COMPETENT
        AUTHORITIES

Information should be disseminated between Competent Authorities and copied to the
Commission for incidents where:

     SFCA is to be taken;
     there is a serious risk to the safety of patients or other users, but where no corrective
      action has yet been established although measures are under consideration, or where
      there is not yet a final report from the manufacturer.



                                                                                                  29
EUCOMED: use exchange criteria of SG2 N20

Competent Authorities should use their discretion where corrective action is taken by a
manufacturer which is not considered to be essential to protect the safety of patients or other
users. Under these circumstances a Competent Authority Report may not be necessary. In
the case of doubt, however, there should be a pre-disposition on the part of Competent
Authorities to disseminate the information.

In addition to vigilance reporting or as an alternative to vigilance reporting when there is no
immediate threat for the safety of patients or other users, the Competent Authority can inform
about a corrective action by a notification on its web-site. (DE)

A recommended format for dissemination of information, using a "Competent Authority
Report" and notes for completion of the report are given at Appendix 8. The manufacturer's
report may be circulated with the Competent Authority Report.

The appropriate "reason for report" should be identified on the Competent Authority Report.
Competent Authorities receiving reports should pay particular attention to the "reason for
report" and any "recommendations" given by the Competent Authority issuing the report. A
number of reports may not require any immediate further action. Wherever possible,
Competent Authorities should direct enquiries arising from the report to the Competent
Authority providing the notification, who will co-ordinate communication with the
manufacturer or Notified Body.

Competent Authority Reports are intended for dissemination between Competent Authorities
and the Commission only, and are not for onward distribution to users or other interested
parties unless otherwise subject to national provisions and practices (Article 20 of MDD and
Article 19 of IVDD).

The dissemination should be performed via EUDAMED.


6.5   DISSEMINATION OF INFORMATION OUTSIDE COMPETENT AUTHORITIES

Careful consideration should be given to the drafting and the dissemination of information by
the Competent Authorities. The possible positive and negative effects of the information to be
disseminated should be considered when drafting advisory notifications and when selecting
the means and medium by which the message is transmitted.

Preference should be given to notification directly to medical practitioner or health-care
facilities concerned.

Medical practitioners or other health-care professionals should be consulted where
appropriate.

The manufacturer should be consulted wherever practicable.

In exceptional circumstances, and only if other means are not appropriate, dissemination of
information direct to the public may be needed. The purpose of such communication will
normally be to suggest that patients or users contact their medical practitioner for further,
more specific advice.

Consideration should be given to the preparation of a statement to the press for use by all
Competent Authorities.



                                                                                              30
The above considerations apply also to dissemination of information by the manufacturer in
consultation with the Competent Authorities.

Interfaces with communication media should be coordinated wherever practicable between
the manufacturer and the Competent Authorities.

It is recommended that Notified Bodies are informed of corrective actions taken by their
manufacturers as a result of the vigilance system to enable them to confirm timely and
appropriate action has been implemented. This information should be provided to them by
the manufacturers but it is also recommended that CAs should inform their Notified Bodies of
relevant cases (eg by copying them with relevant Competent Authority reports)

(Should this also include anonymised CAs regarding all manufacturers ?. [Note : More
detailed guidance covering the activities of NBs in vigilance is nearing completion via
NBOG and reference to this should be made].



8.6    SAFEGUARD CLAUSE (changes may be implemented by directive review)

The application of the Vigilance system does not affect the responsibilities of the Member
States laid down in the Safeguard Clause (Article 7 of AIMD, Article 8 of MDD and Article 8
of IVDD).

The Safeguard Clause procedures remain applicable regardless of the Medical Devices
Vigilance system.


6.6   COMPLETION OF THE INVESTIGATION

The Competent Authority should place the manufacturer's final report on file and make any
other observations necessary. The files investigation may then be endorsed as "complete".

If a Competent Authority itself conducts an investigation, the manufacturer (and, where
appropriate, other Competent Authorities) should be informed of progress and of the results.

The manufacturer’s final report should also be copied to any Competent Authorities who
were informed of the initial report.

The Competent Authority should inform the manufacturer when the investigation is complete,
or if no investigation by the manufacturer is required by the Competent Authority (Note: this
does not preclude the manufacturer investigating as part of their ongoing quality assurance
procedures).

Records of adverse incident reports should be retained to enable the investigation to be
reopened if necessary, and to facilitate systems for trend analysis.



7 The role of the Notified Bodies




                                                                                              31
Even though the Notified Bodies do not play a key role in the vigilance system, the overall
performance of the vigilance system may be enhanced if Notified Bodies are involved in the
following areas:

          Assessment of vigilance procedures
          audit of the implementation of the vigilance procedures, e.g. CAPA, FSCA
          assessment of the impact of vigilance issues on the certification granted
          liaise with the CA if required, e.g specific investigations/audits based on a request
           of the NCA

Further guidance on these areas is provided by NBOG documents or NB recommendations.

NOTE: Isabell will check the wording with Commission.




8 The role of the Commission

…
Transparency:
In cooperation with the Competent Authorities of all Member States the Commission should
extract relevant information out of the vigilance system to make stakeholders and public
aware of existing safety related problems in the field of medical devices. This should include
special information of Notified Bodies, as they are daily involved in the evaluation of devices
and quality systems and therefore their awareness of problems may contribute in particular
to the overall performance of the system.




                                                                                              32
9   REGISTER OF KEY TERMS [DN: to be updated by the Commission]




                                                                  33
APPENDIX 1 LIST OF COMPETENT AUTHORITIES [DN: to be updated by the
Commission]




                                                                     34
35
APPENDIX 3 SUGGESTED INCIDENT REPORT FORMATS

I   Administrative Information

          A. Report Control Number
             1. Mfr’s Internal #
             2. # assigned by NCA to whom sent
             3 User Facility Report #
             4 User Facility #

          B. Report Type (select one)
                           1.     Initial defined as the first information submitted by the
                  manufacturer about a reportable event, but the information is incomplete and
                  supplementary information will need to be submitted. This includes immediate
                  notification
             2. Follow-up         defined as a report that provides supplemental information
                          about a reportable event that was not previously available)
             3. Final     defined as the last report that the manufacturer expects to submit
                          about the reportable event. A final report may also be the first report
             4. Trend defined as information supplied as a result of trending in accordance
                          with SG2 N36
             5. PSR       Periodic Summary report defined in Section 5?
             6. Recall Recall report defined in Section 5?

          C Date of this report

          D. Date the adverse event occurred

      E. Classification of event: (ref N21, N33)
   Unanticipated Death, unanticipated Serious Injury, or Serious Public Health Threat
   All other reportable events

          F. Mfr. awareness date defined as the date that a manufacturer first learned about a
             reportable event

          G. Expected date of next report       i.e., if this is not a “final” report, this represents
             the date when further information will be submitted to the CA

          H. Person, or authorised rep, submitting this report
                 1.       Name of the contact person submitting the report
                 2.       Company Name
                 3.       Address
                 4.       Phone
                 5.       Fax
                 6.       Electronic mail address

          I. Identify to what other NCAs this report was also sent.


    II.         Clinical Event Information

           A.      Event description narrative clarification: relevant information that might
                   impact the understanding or evaluation of the adverse event AND that is not
                   included elsewhere in this report. For example- “the patient was confused prior
                   to becoming trapped in the bedsides”; “the patient was a very low birth weight


                                                                                                         36
               premature delivery and had a central line placed three days before onset of
               cardiac tamponade”; “the X-ray machine was over 20 years old and had been
               poorly maintained at the time of the adverse event”, etc.)

       B.      Number of patients1 involved
       C.      Number of devices involved

III.        Healthcare Facility Information
       A.      Name
       B.      Address
       C.      Phone
       D.      Fax
       E.      Electronic mail address
       F.      Contact Name at the Site of the Event

IV.       Device Information (Repeat this section for each device involved)
       A.    Device Information
             1.      Mfr. Name
             2.      Contact Name
             3.      Address
             4       Phone
             5.      Fax
             6.      Electronic mail address

       B.      Operator of device at the time of the event (select from list below)
               1.    Healthcare professional
               2.    Patient
               3.    Other Caregiver
               4.    None defined as: problem noted prior to use

       C.      Usage of Device (select from list below)
               1.    Initial Use
               2.    Reuse of Single Use Device
               3.    Reuse of Reusable Device
               4.    Re-serviced/Refurbished
               5.    Other, (Please Specify)

       D.      Generic Device Information
               1.     GMDN Nomenclature System
               2.     GMDN Nomenclature Code
               3.     GMDN Nomenclature Code Defined in Text
               4.     Brand Name
               5.     Model #
               6.     Catalogue #
               7.      Device identifiers e.g., serial #, batch #, software version #, etc.

       E.      Device Disposition/Current Location e.g., device has been destroyed, remains
               implanted in patient, was returned to the manufacturer, remains under
               investigation, etc.

       F.      Device approval information
               1.      Regulatory/National Competent Authority who approved device
               2.     Notified Body (NB) who approved device
               3.     Other 3rd party name who approved device
               4.     NB ID number


                                                                                              37
                    5.       Document approval number
                    6.       Class of the device according to directive 93/42/EEC (if applicable)
                    (DE)

      V          Results of Manufacturer’s Investigation
            A.      Manufacturers Device Analysis Results        Specify, for this event, details of
                    investigation methods, results, and conclusions. Including reasons for any
                    Recall or not making FSCA.

            B.      Remedial Action/Corrective Action/Preventive Action
                    Specify if action was taken by manufacturer for the reported specific event or
                    for all similar type products. Include what action was taken by the
                    manufacturer to prevent recurrence. Clarify the timeframes for completion of
                    various action plans. Any proposed Recall actions should be provided here,
                    together with any linked (draft) advisory notice.
                    For all recalls provide:


            C.      Adverse event nomenclature (to be used once a suitable nomenclature is
                    endorsed by the MDEG for use within EUDAMED)
                    1. Adverse event type code(s) 1,2 and 3 level. (EUDAMED)
                    2. Adverse event cause code(s) 1,2, and 3 level. (EUDAMED)
                    3. Patient/user/other outcome code (SNOMED CT)

      VI.      Patient4 information (Repeat this section for each patient involved)
            A.    Provide individual patient information for each element as appropriate

            B.      Age of patient in years at time of event             (If less than 1 year calculate as
                    fraction of 365 days)

            C.      Gender

            D.      Weight in Kilograms (metric units will be assumed)

            E.      List of Devices involved with each patient, see Section IV

            F.      Patient-focused Resolution of Events and Outcomes
                    1.      Corrective action taken relevant to the care of the patient
                    2.      Patient outcome

      VII.    Other Reporting Information (to be included as soon as available, especially for
      final reports)
             Is the mfr aware of similar events with this device with the same root cause?
                Y/N
             If yes, provide the number of the events- The " number" should be specified in
                terms of event per unit sold, or the number of event per unit sold / in use in a
                region, etc. Also if yes then provide
             if yes, the names of any other Competent Authorities to which these incidents
                have been reported, and the reference/date of the report(s);
             any other EEA State in which the device is known to be on sale;
             name and address of the local distributor in the EEA State to which the report
                has been sent; es: check

4
    Includes any affected individual eg user, patient, or third party.


                                                                                                             38
      VIII.   Comments

IX.       Manufacturer Disclaimer

Notes:
1. Dates should be formatted as follows: 2 digit day, 3 letter month, 4 digit year, e.g., 01
    JAN 2001
2. Age should given in years or fractions of a year, any other timeframes, should specify if
    counted in days, months or years .
3. A reasonable effort should be made to address all elements defined below, however
    failure or inability to do so is not justification for failing to submit a report within the
    established timeframes.
4. Electronic addresses are desired whenever available.
5. Each field must be completed with the requested information or “NA” if not applicable to
    the event or “unknown” when the data is not available.
6. Please use the comments section at the end to provide any additional details that are
    relevant and not requested elsewhere.
7. Additional data may be provided to explain, illustrate or augment the report but this is not
    to be used as a substitute for the report. Where electronic reporting facilities exist
    additional data can usually be added as separate electronic documents.
8. In order to avoid the connotation of blame, information identifying the Health Care Facility
    or the User may be considered optional in certain NCA systems.
9. Manufacturers and NCAs need to be aware that patient privacy requirements must be
    honoured where applicable.
10. es: Note for manufacturers regarding for GHTF exchange




                                                                                              39
        APPENDIX 4 SIMPLIFIED FLOWCHART – ILLUSTRATION OF INCIDENTS TO BE
        REPORTED

         SIMPLIFIED FLOW CHART – IDENTIFICATION OF INCIDENTS TO BE REPORTED BY
                      MANUFACTURERS UNDER THE VIGILANCE SYSTEM
        THIS FLOWCHART IS FOR ILLUSTRATIVE PURPOSES ONLY. SEE TEXT FOR DETAILS




                                                                        Could have
                            Death or             No                                       No
                                                                         occurred                   No report
                             serious
                              injury
                            occurred

                                          Yes                                     Yes


            Yes             Can confirm                                                 Yes
                           within 10 days                               Can confirm
No report                                                              within 30 days             No report
                          that not caused
                             by device                                that not caused
                                                                         by device




                                          No                                    No



                           Incident                                    Incident
                          occurred in                                 occurred in
                             EEA                                         EEA
                                                No             No


                                          Yes
                                                                                  Yes




                          Device carries
                                CE mark                                    Device
                                                                         carries CE
              Yes                               No               No         mark
                                                                                            Yes




                                                        Outcome
                                     No                 identifies
                    No report
                                                     problems with
                                                       similar CE
                                                     marked devices




                                                               Yes


         INCIDENT                                     REPORT                              Near INCIDENT
      (report- see text                              (as soon as                                       40
                                                                                        (report- see text for
         for details)                                 possible)                               details)
APPENDIX 5 EXAMPLES OF INCIDENTS AND NEAR INCIDENTS WHICH THE
MANUFACTURER SHOULD REPORT

Add several IVD examples (NO) Could industry proved us with god examples?
Incoporate the examples of appendix 10 (Eucomed, NO)
We have to discuss whether the IVD examples should be incorporated with the general
examples or be in an appendix with IVD examples only.


The following examples are for illustrative purposes only, and are for the guidance of the
manufacturer in determining whether a report should be made to a Competent Authority. The
examples are intended to show that there is a considerable judgmental element in the
decision on whether to report.

1. A patient dies after the use of a defibrillator and there is an indication of a problem with the
defibrillator. The incident should be reported.

2. A patient receives a burn during the use, in accordance with the manufacturer's
instructions, of surgical diathermy. If the burn is significant, this should be reported as such
an injury is not normally expected.

3. An infusion pump stops, due to a malfunction of the pump, but fails to give an appropriate
alarm; there is no patient injury. This should be reported as a "near incident" as in a different
situation it could have caused an injury.

4. An infusion pump delivers the wrong dose because of an incompatibility between the
pump and the infusion set used. If the combination of pump and set used was in accordance
with the instructions for use for either pump or set, then the incident should be reported.

5. An aortic balloon catheter leaked because of inappropriate handling of the device in use,
causing a situation which was potentially dangerous to the patient. It is believed that the
inappropriate handling was due to inadequacies in the labelling. The incident should be
reported as a "near incident".

6. A catheter fractured during insertion, with no suggestion of inappropriate handling. The
fracture occurred in such a position that the broken part could easily be withdrawn. However,
this was clearly a fortunate circumstance as if the catheter had fractured in a slightly different
position then surgical intervention would have been necessary to retrieve the broken end.
This should be reported as a "near incident".

7. Glass particles are found in a contact lens vial. This should be reported as a “near
incident”.

8. A defect is discovered in one (hitherto unopened) sample of a batch (lot) of a contact lens
disinfecting agent that could lead to incidence of microbial keratitis in some patients. The
manufacturer institutes a recall of this batch. The recall should be reported.

9. Loss of sensing after a pacemaker has reached end of life. Elective replacement indicator
did not show up in due time, although it should have according to device specification. This
incident should be reported.

10. On an X-ray vascular system during patient examination, the C arm had uncontrolled
motion. The patient was hit by the image intensifier and his nose was broken. The system
was installed, maintained, and used according to manufacturer’s instructions. This incident
should be reported.


                                                                                                   41
11. The premature revision of an orthopedic implant is required due to loosening. Although
no cause is yet determined, this incident should be reported.

12. The manufacturer of a pacemaker has identified a software bug in a pacemaker that has
been placed on the market. The initial risk assessment identified the risk of a serious injury
as remote. Subsequent failure results and the new risk assessment carried out by the
manufacturer indicate that the likelihood of occurrence of a serious injury is not remote. This
should be reported.

13. Fatigue testing performed on a commercialised heart valve bioprosthesis demonstrates
premature failure, which resulted in a risk to public health. This should be reported as a “near
incident”.

14. Manufacturer provides insufficient details on cleaning methods for reusable surgical
instruments used in brain surgery, despite obvious risk of transmission of CJD.




                                                                                             42
APPENDIX 6 SIMPLIFIED FLOWCHART ILLUSTRATING THE REPORTING OF
RECALLS

      DECISION TREE – IDENTIFICATION OF RECALLS TO BE REPORTED BY
             MANUFACTURERS UNDER THE VIGILANCE SYSTEM




                                            No
                      RECALL FOR
                      TECHNICAL/
                                                 NO REPORT
                       MEDICAL
                       REASON




                              Yes




                   DUE TO RISK OF
                     DEATH OR               No
                     SERIOUS                     NO REPORT
                      INJURY




                              Yes



                    INCLUDES AT
                     LEAST 1 CE-            No    NO REPORT
                       MARKED
                      ITEM/ UNIT




                              Yes



                  VIGILANCE RECALL
                   (Report on or before
                issue of Advisory Notice)




                                                                    43
APPENDIX 7 EXTRACTS FROM DIRECTIVES RELATING TO "MEDICAL DEVICES
VIGILANCE"

1. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the
Member States relative to active implantable medical devices

A. Article 8

1. Member States shall take the necessary steps to ensure that information brought to their
knowledge regarding the incidents mentioned below involving a device is recorded and
evaluated in a centralised manner:

a) any deterioration in the characteristics and performances of a device, as well as any
inaccuracies in the instruction leaflet which might lead to or might have led to the death of a
patient or to a deterioration in his state of health;

b) any technical or medical reason resulting in withdrawal of a device from the market by the
manufacturer.

2. Member States shall, without prejudice to Article 7, forthwith inform the Commission and
the other Member States of the incidents referred to in paragraph 1 and of the relevant
measures taken or contemplated.

B. Annexes 2, 4, 5

Extracts :

- an undertaking by the manufacturer to institute and keep up-dated a post-marketing
surveillance system. The undertaking shall include an obligation for the manufacturer to
notify the competent authorities of the following incidents immediately on learning of them :

i) any deterioration in the characteristics or performances, and any inaccuracies in the
instruction leaflet for a device which might lead to or have led to the death of a patient or a
deterioration in his state of health;

ii) any technical or medical reason resulting in withdrawal of a device from the market by the
manufacturer.

2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

A. Article 10 : Information on incidents occurring following placing of devices on the market

1. Member States shall take the necessary steps to ensure that any information brought to
their knowledge in accordance with the provisions of this Directive, regarding the incidents
mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally :

a) any malfunction or deterioration in the characteristics and/or performance of a device, as
well as any inadequacy in the labelling or the instructions for use which might lead to or
might have led to the death of a patient or user or to a serious deterioration in his state of
health;

b) any technical or medical reason in relation to the characteristics or performance of a
device for the reasons referred to in subparagraph (a), leading to systematic recall of devices
of the same type by the manufacturer.



                                                                                                  44
2. Where a Member State requires medical practitioners or the medical institutions to inform
the competent authorities of any incidents referred to in paragraph 1, it shall take the
necessary steps to ensure that the manufacturer of the device concerned, or his authorized
representative established in the Community, is also informed of the incident.

3. After carrying out an assessment, if possible together with the manufacturer, Member
States shall, without prejudice to Article 8, immediately inform the Commission and the other
Member States of the incidents referred to in paragraph 1 for which relevant measures have
been taken or are contemplated.

B. Annexes II, IV and V

Extracts :

- an undertaking by the manufacturer to institute and keep up to date a systematic procedure
to review experience gained from devices in the post-production phase and to implement
appropriate means to apply any necessary corrective action. This undertaking must include
an obligation for the manufacturer to notify the competent authorities of the following
incidents immediately on learning of them :

i)any malfunction or deterioration in the characteristics and/or performance of a device, as
well as any inadequacy in the instructions for use which might lead to or might have led to
the death of a patient or user or a serious deterioration in his state of health;

ii) any technical or medical reason connected with the characteristics or performance of a
device leading for the reasons referred to in subparagraph (i) to systematic recall of devices
of the same by the manufacturer.

3. Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices

A. Article 11 : Vigilance Procedure

1. Member States shall take the necessary steps to ensure that any information brought to
   their knowledge, in accordance with the provisions of this Directive, regarding the
   incidents mentioned below involving devices bearing the CE marking is recorded and
   evaluated centrally:

(a) any malfunction, failure or deterioration in the characteristics and/or performance of a
    device, as well as any inadequacy in the labelling or the instructions for use which,
    directly or indirectly, might lead to or might have led to the death of a patient, or user or of
    other persons or to a serious deterioration in their state of health;
(b) any technical or medical reason in relation to the characteristics or performance of a
    device for the reasons referred to in subparagraph (a), leading to systematic recall of
    devices of the same type by the manufacturer.

2. Where a Member State requires medical practitioners, the medical institutions or the
   organisers of external quality assessment schemes to inform the competent authorities of
   any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that
   the manufacturer of the device concerned, or his authorised representative, is also
   informed of the incident.
3. After carrying out an assessment, if possible together with the manufacturer, Member
   States shall, without prejudice to Article 8, immediately inform the Commission and the
   other Member States of the incidents referred to in paragraph 1for which appropiate
   measures, including possible withdrawal, have been taken or are contemplated.



                                                                                                 45
4. Where, in the context of notification referred to in Article 10, a device notified, bearing the
   CE marking, is a “new” product, the manufacturer shall indicate this fact on his
   notification. The competent authority so notified may at any time within the following two
   years and on justified grounds, require the manufacturer to submit a report relating to the
   experience gained with the device subsequent to ist being placed on the market.
5. The Member States shall on request inform the other Member States of the details
   referred to in paragraphs 1 to 4. The procedures implementing this Article shall be
   adopted in accordance with the procedure referred to in Article 7(2).

B. Annexes III, IV, V and VII

6. The manufacturer shall institute and keep up to date a systematic procedure to review
   experience gained from devices in the post-production phase and to implement
   appropriate means to apply any necessary corrective actions, taking account of the
   nature and risks in relation to the product. He shall notify the competent authorities of the
   following incidents immediately on learning of them:

(i)    any malfunction, failure or deterioration in the characteristics and/or performance of a
       device, as well as any inadequacy in the labelling or the instructions for use which,
       directly or indirectly, might lead to, or might have led to, the death of a patient or user
       or other persons or to a serious deterioration in his or their state of health;
(ii)   any technical or medical reason connected with the characteristics or the
       performance of a device for the reasons referred to in subparagraph (i) leading to
       systematic recall of devices of the same type by the manufacturer.




                                                                                                46
   APPENDIX 8 SUGGESTED NATIONAL COMPETENT AUTHORITY REPORT FORMAT

                  SUGGESTED COMPETENT AUTHORITY REPORT FORMAT

   Insert link to GHTF N9R11 form together with a cross reference link to N20R10 and 8.4.

   Advise to Eudamed (NO); The Competent Authority Reporting Form (N9R11) should be
   used. When the European database for Medical Devices (EUDAMED) is in full operation, the
   database should be used for information exchange. (NO)


                    THE MEDICAL DEVICES VIGILANCE SYSTEM REPORT
        Ref AIMD 90/385/EEC, art 8, MDD 93/42/EEC, art 10 and MEDDEV 2.12/1 3/93-rev 2
     This form should be used for the exchange of information between National Competent
                                        Authorities only
1. Report from CA of: __________ 2. Ref no: _____________________ 3. Sent by:
___________________________
                     (country)            (national seq. no.)              (date)                 (sign)
4. Contact point: _________________________ 5. Contact person: __________________
6. Tel:________________________ 7. Fax:____________________ 8. E.mail:
    ____________________


                                                                                   18. Concerned
DEVICE DATA                                                                        Notified Body no:
9. Generic name/ kind of device:

10. Nomenclature id:____________________ 11. No: _____________                     1. Was the
      (which nomenclature)                  (code)                                    Safeguard
                                                                                      Clause used?
                                                                                      No      Yes

12. Type:                                                                          2. Is the device
                                                                                   CE-marked? :
13. Software version:                                                              No      Yes

14. Serial no:                         15. Lot/batch no:                           Class:

16. Manufacturer/authorized rep:                 17. Country:
    _______________________Tel: _________________
For pt 21-22-23 use additional pages if necessary.
21a. Background information / reason for this report:


21b.: Serious risk to patient safety


22a. Conclusions/corrective action:


22b. Corrective action to be taken in the following Member States:

CA in               is willing to take the lead and coordinate the investigation


                                                                                                47
23. Recommendation to receivers of this report:




24. This report has been sent to the following MDVS Contact Points:
All EEA states A B D DK E EL F FIN IRL
IS I L NL N P S UK EC ESA EFTA as well as
The manufacturer/                                                CA in:
authorized rep:


   MEDICAL DEVICES VIGILANCE REPORT FORM

   Instructions for filling in the Competent Authority report:

   Format – General remarks
   This form should be used by Competent Authorities only when exchanging information about
   relevant measures and/ or recommendations relating to the prevention of adverse incidents
   concerning medical devices.
   The Competent Authority filling in and sending the form will be responsible for the quality of
   the content as well as the appropriateness of sending such a message. The content should
   normally be considered to be <<commercial in confidence>> and hence handled accordingly.
   Before releasing any information from a received report, careful note should be taken
   concerning the most appropriate way to do this.

   Items 1-8 – concerning the Reporter
   These items must clearly identify the Competent Authority responsible for this Report and
   making it possible for the receiving Competent Authority to contact the Originating
   Competent Authority for further information.

   Items 9-17 – Device Data
   To make certain the device in question is properly identified by all, these items must give as
   much accurate information as possible. If the device can be classified in a recognized
   nomenclature (e.g. GMDN, NKKN, UMDNS) this will be of value (no 10). 14-15 identifies
   devices affected by this report. Items 16-17 points to who is legally responsible for placing
   the device in question on the market in the area where the incidents occurred. Telephone
   number will ease follow-up contact.

   Item 16
   Manufacturer or Authorized Rep should be deleted as appropriate.

   Item 18
   Give four digit number of the Notified Body concerned.

   Item 19
   State here if the Safeguard Clause is used.

   Item 20
   CE-marking and Risk Class of the device concerned should be notified here.




                                                                                                48
Item 21 - Reason for this report
Here a description of what has happened, as well as factual background information, should
appear. Such information might lead to a better understanding on how to make an
appropriate follow-up. Similarly, who has done the investigation leading to this report could
be of importance for further action.

Item 22 - Conclusions or corrective actions
This will describe the outcome or the conclusions of the investigation, including any
corrective actions, for example recalls. Normally at this stage the investigation will have
reached some conclusions or be finalised. There can, however, be reasons for disseminating
an alert at an earlier stage, even without conclusive evidence of a serious risk to patient
safety. Sometimes an Authority volunteers for a role as a coordinator of any further
investigation.

Item 23 - Recommendations to receivers of this report
Here should appear what action the receiving Authority is recommended to do nationally
upon being informed. If known, it should appear here in which countries the device has been
sold.

Item 24 – This report has been sent to the Competent Authorities in
Normally it will be of help, or of support, to know who else has received this Report. The
manufacturer, or his authorized representative, should always be provided with a copy.




                                                                                             49
APPENDIX 9 DIAGRAM OF THE VIGILANCE SYSTEM

                                      MEDICAL DEVICE VIGILANCE – INCIDENT RESPONSE

     Role of manufacturer                               Role of Competent Authority          PROCEDURE
                             either     Incident   or


     Informed of incident                  1            Informed of incident                 1 – INFORM

Initial assessment/report                  2            Informed by manufacturer within      2 – ASSESS
                                                        agreed timescales – see text for
                                                                    details

  Propose/implement action                 3            Monitor initial action
                                                                                             3 – REVIEW

       Full investigation                  4                  Informed of progress
                                                                                             4 – INVESTIGATE

  Propose/implement action                 5                  Informed consultation
                                                                                             5 – ACTION

      Final report issued                  6             Receive (or prepare) final report
                                                                                             6 – CONCLUSION

                                           7                 Inform other European
                                                             Competent Authorities           7 – INFORMATION


                                           8                                                 8 – FILE
               END                                                    END
           (File report)                                          (File report)




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APPENDIX 10 SPECIFIC REQUIREMENTS FOR IN VITRO DIAGNOSTIC DEVICES

10.1    Introduction

This section deals only with aspects of vigilance reporting that are specific to in vitro
diagnostic medical devices (IVD). It must be read in conjunction with the generic guidelines.

Vigilance reporting for IVDs may be more difficult since IVDs do not generally come into
contact with patients. Therefore, it can be difficult to demonstrate direct harm to patients,
unless the device itself causes injury. Harm to patients is more likely to be indirect - a result
of action taken on the basis of an incorrect result obtained with an IVD. Whether as a result
of direct or indirect harm, incidents and near incident should be reported.

With IVDs, it is common for two or more separate devices (and/or accessories) to be used in
combination – often from different manufacturers. In this instance refer to generic guidance
(section 4.1.5).

10.2   Direct harm

For incidents and near incidents involving direct harm to patients, users and third parties,
manufacturers are directed to the generic vigilance guidelines which provide guidance on
which types of incidents and near incidents should be reported.

In addition, the following specific examples should be considered as serious injury:
                infection with biological agents (for example, when potentially biohazardous,
                or toxic material including specimens for analysis enters into a mucus
                membrane, eye, or open wound or penetrates the skin of a user or other
                person).

10.3   Indirect Harm:

In these incidents, the IVD does not act directly upon the individual who is harmed or could
be harmed. Instead harm occurs as a consequence of the medical decision, or action, taken
on the basis of information provided by an IVD. Examples include
       misdiagnosis,
       delayed diagnosis,
       delayed treatment,
       inappropriate treatment,
       transfusion of inappropriate materials.
Note that, for self-testing devices, a medical decision may be made by the user of the
device-who is also the patient

Incorrect results obtained with an IVD may arise from a faulty or inappropriately designed
IVD, for example, the device does not achieve the claimed sensitivity or specificity or gives
rise to user/device interface problems.

It may be difficult to determine if a serious deterioration in the state of a patient’s health was
or could be the consequence of an erroneous result obtained with an IVD, or if the harm was
the consequence of an error by the user or third party.

In the case of potential errors by users or third parties, labelling and instructions for use
should be carefully reviewed for any possible inadequacy. This is particularly true for devices
used for self-testing where a medical decision may be made by the patient. Inadequacies in




                                                                                                51
the information supplied by the manufacturer that led or could have led to harm to users,
patients or third parties should be reported.

In particular, it can be extremely difficult to judge potential near incidents in which no harm
was caused, but where harm could result if the incident was to occur again elsewhere. For
example, when an incorrect result is obtained with a IVD and no medical action is taken but
there could have been severe adverse medical consequences if the result had been acted
upon.

10.4 Examples of reportable incidents involving IVDs

10.3.1 A batch of out-of-specification blood glucose test strips is released by manufacturer.
       A patient uses the strips according to the manufacturer’s instructions, but the
       readings provide incorrect values leading to incorrect insulin dosage, resulting in
       hypoglycemic shock and hospitalization. This incident should be reported.
10.3.2 A customer reports a wrong assignment of analytical results to patient codes by an
       automated analyzer. An evaluation could reproduce the effect and indicated that
       under specific conditions a data mismatch could occur. Due to the data mismatch a
       patient suffered from wrong treatment. This incident should be reported.
10.3.3 During maintenance of a self-testing analyzer for patients it was detected that a screw
       which places the heating unit of the analyzer in exact position had come loose. Due
       to this fact, it may happen that the heating unit leaves it’s position and the
       measurement is performed under non exact temperature, which would lead to wrong
       results. As this could lead to wrong treatment of the patient this should be reported as
       a near incident.
10.3.4 During stability testing of a CRP test the internal quality control found that after
       several months of storage false increased values are measured with neonatal
       samples. This could lead to the wrong diagnosis of the existence of an inflammatory
       illness and to a wrong treatment of the patient. This should be reported as a near
       incident.




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Appendix

Titles of Global Harmonisation Task Force, Study Group 2 documents used in the
development of this MEDDEV


   SG2/N31R8 Medical Device Postmarket Vigilance and Surveillance: Proposal for
    Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized
    Representative
   SG2/N32R5 Medical Device Postmarket Vigilance and Surveillance: Universal Data Set
    for Manufacturer Adverse Event Reports
   SG2-N36R7 Manufacturer's Trend Reporting of Adverse Events
   SG2-N9R11 Global Medical Device Competent Authority Report
   SG2-N33R11 Medical Device Postmarket Vigilance and Surveillance: Timing of Adverse
    Event Reports
   SG2-N20R10 Medical Devices: Post Market Surveillance: National Competent Authority
    Report Exchange Criteria
   SG2-N7R1 Minimum Data Set for Manufacturer Reports to Competent Authority
   SG2-N8R4 Guidance on How to Handle Information Concerning Vigilance Reporting
    Related to Medical Devices
   SG2-N21R8 Adverse Event Reporting Guidance for the Medical Device Manufacturer or
    its Authorized Representative




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