Medical Device Directives

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					        Medical Device
          Directives
         Regulations
          Standards
             Wilf Higgins
          B.E.,M.B.A.,M.Sc.,F.I.E.I.
            Chartered Engineer
  Principal Engineering Adviser HSE
Chairman ACMD Irish Medicines Board
          Board Member IMB
   Chairman ABHS CEN Brussels
              Legislative Process
•   Commission
•   European Parliament
•   Council of Ministers
•   National Government
•   European Communities Act 1972
        Legislation governing Medical Devices
•   AIMD                           90/385/EEC
•   MDD                            93/42/EEC
•   IVD                            98/79/EC
•   Revision MDD                   2007/47EC
•   Implementing Legislation
•   Human Blood Derivatives           2000/70/ &
                                           2001/104EC
•   Common Technical Specs            2002/364/EC
•   Reclassification of breast implants    2003/12/EC
•   Tissues of Animal Origin.         2003/32/EC
•   Reclassification of hip, knee, and 2005/50/EC
    shoulder joints
  Irish Legislation for Medical Devices

• S.I. No. 252 of 1994 (MDD)
• S.I. No. 253 of 1994 (AIMD)
• S.I. No. 304 of 2001 (IVD)
• S.I. No. 444 of 2001 (IMB as CA)
• S.I. No. 576 of 2002      (Blood Products)
• S.I. No. 358 of 2003 (Reclassification of
                       Breast Implants)
• S.I. No. 554 of 2003 (Tissues of Animal Origin)
• S.I. No 92 of 2007   Reclassification of (TJ R)
         Competent Authority
• The body who acts on behalf of the
  government of a Member State to ensure that
  the requirements of the Medical Devices
  Directives are carried out in that particular
  Member State.
• The primary role of the CA is to ensure that all
  medical devices sold on the Irish market meet
  the Essential Requirements of the Directives
  and in doing so do not compromise the health
  and safety of patients, users and where
  appropriate, any other persons
Competent Authority Functions
• Register of -
      Class 1 Manufactures ,
      Custom Made Device Manufacturers
      Authorized Representatives,
  System & Procedure Pack Assemblers
• Inspection of Class I
• Vigilance
• Clinical Trials
• Notified Bodies
• Post Market Surveillance
What is a Medical Device?

Medical Devices can range from walking
sticks to bone cement to pacemakers to
in-vitro diagnostic kits. The range is
broad and complex. Examples include:
- surgical sutures, bandages, blood bags,
irrigation solutions intended for mechanical
rinsing, X ray equipment, drug delivery
pumps, HIV test kits, pregnancy test kits
               Medical Device
• 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
• 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.
• Accessory
• Custom Made Device
• AIMDD       Energy Source
              Permanent implant
•IVD
        'in vitro diagnostic medical device` means any
medical device which is a reagent, reagent product,
calibrator, control material, kit, instrument, apparatus,
equipment, or system, whether used alone or in
combination, intended by the manufacturer to be used
in vitro for the examination of specimens, including
blood and tissue donations, derived from the human
body, solely or principally for the purpose of providing
information:
•- concerning a physiological or pathological state, or
•- concerning a congenital abnormality, or
•- to determine the safety and compatibility with
potential recipients, or
•- to monitor therapeutic measures.
               Custom Made Device

• Device specifically made in accordance with a duly
  qualified medical practitioner's written prescription
  which gives, under his responsibility, specific design
  characteristics and is intended for the sole use of a
  particular patient.
• The above mentioned prescription may also be
  made out by an other person authorized by virtue of
  his professional qualifications to do so.
• Mass-produced devices which need to be adapted
  to meet the specific requirements of the medical
  practitioner or any other professional user are not
  considered to be custom -made devices.
             Manufacturer
• 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
    Authorized Representative
• natural or legal person established within
  the community who explicitly designated
  by the manufactured acts and may be
  addressed by authorities and bodies in the
  community instead of the manufacturer
  with regard to the latter's obligations under
  this directive
                Notified Body
• Certification organization which the
  Competent Authority has designated to
  carry out conformity assessment
  procedures.
• One designated in Ireland.
• National Standards Authority of Ireland
     AIMDD Annexes 2&5
     MDD         Annexes 2,5&6
     IVD         Annex II List A( Virology)
                 Annex II List B , Self Test.
               CE Mark

• Devices meeting the Essential
  Requirements of the Directives will be
  entitled to carry the “CE Marking” which
  indicates conformance with the
  appropriate Directive. Once devices are
  CE Marked they can be freely marketed
  anywhere in the EEA without further
  control
                      Classification
Class      Type              Conformity Assessment


  I      Low risk                  Manufacturer


 IIa    Medium risk         Notified Body at production


 IIb     High risk     Notified Body at design and production



 III     High Risk     Notified Body at design / production +
                           verification of design dossiers
              Classification
• Class I      Irish Medicines Board
• Class I      Notified Body
               (measuring function or sterilisation)
• Class IIa    Notified Body
• Class IIb    Notified Body
• Class III    Notified Body
              Determine Conformity
               Assessment Route
       Class I                       Annex VII + Annex V
       Sterile / Measuring           for Sterile / Measuring
                                     aspects

       Class II a                    Annex II
                                     Annex VII + V
                                     Annex VII + VI

       Class II b                    Annex II
                                     Annex III + V
                                     Annex III + VI

       Class III                     Annex    II
                                     Annex    III + V




Annex II Full QA : Annex III Type Examination : Annex V Production QA
Annex VI Product QA:     Annex VII Declaration of Conformity
 Steps to Obtaining a CE Mark
• Determine correct classification
• Clinical investigation or literature review
  needed?
• Choose a Notified Body
• Put in place a site quality system
• Choose Conformity Assessment Route for
  the medical device
• Prepare and submit application
• Post Market follow up after CE marking
            Aids to Determine
              Classification
• Directive 93/42/EEC and S.I. No. 252 of 1994
  – Annex or Schedule 9
• Med.Dev 2.4/1 Rev 8 July 2001
• Discuss with Notified Body
• Review similar devices on the market
      What is Risk Analysis?

Results should be used to to determine
whether the risks associated with the use of
the product (according to intended use) are
acceptable when evaluated against the
benefits of the device to the user. Should be
based on recognised standards, and be
appropriate to the complexity and risk class
of the device
         Tools to Assist
   Determination of Conformity
             Route
• Directives and Regulations
• Standards and guidance
  – Med.dev guidance
  – EN: harmonised standards
  – ISO: standards
  – National guidance
• Notified Body guidance
  Requirements of a Low Risk
     Device Manufacturer
• Registration with the IMB

• CE Marking

• EC Declaration of Conformity

• Technical Documentation / File

• Post Market Surveillance Records
    Requirements for Class IIa

• Site Quality System approved by a Notified Body
  i.e full quality system approval production quality
  assurance or product quality assurance (type
  testing) with declaration of conformity.

• Site audit

• Declaration of conformity

• Clinical investigation not normally required
        Class IIb and Class III

• Site quality assurance i.e full quality
  assurance or EC type testing and production
  quality assurance

• Require clinical investigations

• Design dossier is required
    Notified Body Procedure

• Application accepted
• Application reviewed and questions
  issued
• Site audit
• Design dossier review
• CE marking granted
• Ongoing surveillance audits – approx 18
  month cycle
           CE Certification

• Three to five year period of validity

• Manufacturer must report vigilance /
  recall activities to Competent Authority

• Post Market Surveillance is fundamental
  to the use of the system
                     Vigilance
• New MEDDEV 2.12-1 rev.5 04-2007
• 1. The structure

•   Introduction
•   Definitions
•   Manufacturers role
•   Responsibilities of the Competent Authority
•   Role of the Notified Body
•   Role of the Commission
•   Role of the users

• 2.   The removal of the term ‘near incident’
                              Vigilance
•   3.    Field Safety Corrective definition
•         A „field safety corrective action‟ taken by a manufacturer to prevent or
    reduce the risk of death or serious deterioration in the state of health
    associated with the use of a medical device. These 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 manufacturer 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)

•   4.    Reporting Criteria - three basic reporting criteria
•         a)        An event has occurred
•         b)        The manufacturer‟s device is suspected to be a contributory
    cause of the INCIDENT
•         c)        The event led, or might have led, to death or serious
    deterioration in health
                      Vigilance
5. Reporting Methods
   – Standard vigilance reports
   – Summary report
   – Trend report

6. User error – USE ERROR and abnormal use are
   now reportable

7. Reporting timelines clarification e.g. immediate
   within 2 days for serious issues
                  Clinical Trials
•   Investigation plan
•   Ethics Committee Approval
•   Risk Assessment
•   Clinical investigation, clinical evaluation
    Guide for manufacturers and notified bodies 2.7.1
    March 03
         Key Issues that Arise
• Risk Analysis require specific attention
• Label claims – classification issue
• Drug / device combinations
  – Correct classification
  – Is the product a medical device, medicine, cosmetic,
    other
• Design dossier – must have adequate
  information
• Low numbers in Clinical Investigations leads to
  ongoing monitoring in vigilance
• Technical File particularly for class I devices -
  must have adequate information
      Revision of Medical Devce
              Directives
Changes proposed to:
  •   Definitions e.g. medical purpose
  •   Conformity assessment
  •   Clinical evaluation requirements
  •   Post market surveillance
  •   Transparency
  •   Co-operation
           MDD review – Clinical
             Investigations
• Increasing emphasis on specific clinical data for all
  devices

• Need to demonstrate equivalence – may need to do
  both

• Enhanced post-market clinical follow up to gather data

• Increased adverse event reporting

• Increased communication – databank
Increasing emphasis on specific clinical data for
all devices

Need to demonstrate equivalence – may need to
do both

Enhanced post-market clinical follow up to gather
data

Increased adverse event reporting

Increased communication – databank
 Impact of Changes to the Medical
   Devices Directive 93/42/EEC
• Improved clarity for all parties
• More data to be supplied regarding clinical
  performance of devices and subsequent
  changes
• Focus on representative sampling of technical
  data by NB and control of sub-contractors
• EUDAMED to be made functional / available
• Improved co-operation and sharing of CA
  resources in the EU – impact on market
  surveillance
• Confidentiality and transparency
              Way Forward

• Be familiar with legislation
• Consultation with all parties at an early stage,
  particularly Notified Body
• Carry out appropriate risk analysis related to
  the class of device
• Prepare product for CE submission keeping in
  mind legislative requirements and standards
• Check similarity to other similar products on
  market
    Harmonised Standards
Part of “New Approach” Directives
EC Directives define “essential
 requirements”
Protection of health
Safety
European Standards Bodies draw up
 corresponding technical specifications or
 “harmonised standards”
        Harmonised Standards
“Harmonised standards” are European
  standards, adopted by CEN, CENELEC or
  ETSI, following a mandate issued by the
  European Commission after consultation
  of Member States”
CEN:       Comité Européen de Normalisation
CENELEC:   Comité Européen de Normalisation Electrotechnique
ETSI:      European Telecommunications Standards Institute
   Harmonised Standards
 Only harmonised when published in the
  Official Journal of the communities
  ( Approx 200)
 Can be withdrawn
 Web site but official list is the OJ
 http://ec.europa.eu/enterprise/newapproa
  ch/standardization/harmstds/reflist/medde
  vic.html
 Harmonised Standards
Notified Body Expectations


 Knowledge of applicable standards (feedback)

 Implementation (not retrospectively unless
  mandated)

 Evidence of conformity
    Harmonised Standards
            How to keep track

Look at the web-site
Membership of industry organizations (IMDA,
  EUCOMED)
Participate in HCSC /ETCI
Standards Information Service
Trade Journals
    Standardisation in Ireland
• National Standards Authority of Ireland
  (NSAI)
• Health Care Standards Consultative
  Committee follows CEN & ISO work
• ElectroTechnical Council of Ireland (ETCI)
• TC 10 & TC 2 follow CENELEC & IEC
  work
    Harmonised Standards
How to use harmonised standards
 Annex‟s: Normative or informative (A to Z)
 Z - Links Standard to Directive (Normative)

 Incorporate appropriately into the organization
  design
  management
 Indicate their application against the essential
 requirements
Harmonised Standards
 Pecking Order

 Harmonised Standard
 EN standard
 ISO standard
 National Standard
 Other Standard
 Industrial
   Harmonised Standards
Harmonized standard        =   presumption of conformance


Deviation                     presumption of conformance


Deviation + Scientific  =      presumption of conformance
     justification
Non-Harmonized standard       presumption of conformance
Non-Harmonized standard + = presumption of conformance
proof of equivalence to HS
Harmonised Standards

 In Summary:

  Know your standards

  Apply in full or in part with justification

  Have readily available proof of compliance
 Harmonised Standards ISO
          CEN
       Main Reference Standards
EN 13485-2003 Quality Management
 Systems
EN 14971-Application of Risk Management
 to Medical Devices
EN 10993 part 1 – 11
  Biological Evaluation
    Harmonised Standards

ISO 13485-2003 Quality Management
 Systems)
ISO 14155-1-2003 Clinical Investigation of
 Medical Devices
EN 550/552/554/556- Sterilization
EN 980-Graphical Symbols
EN 1041-Information supplied
EN 1174 1-3-Sterilisation
EN 12442-1-3- Animal Tissues
     Harmonised Standards IEC
             Cenelec
• Electrical Standards
• 60601-1 (1-4) General Requirements
• 60601-2 (xxx) Particular Requirements

• Electrical Installations
• IEC 60364-7-710
• 3rd Edition National Wiring Rules
           Quality Systems
• The ISO 9000 family is primarily concerned with
  "quality management". This means what the
  organization does to fulfil:
• - the customer's quality requirements, and
  - applicable regulatory requirements, while aiming to
  - enhance customer satisfaction, and
  - achieve continual improvement of its performance in
  pursuit of these objectives.
• ISO 9001:2000
• ISO 13485-2003 Quality Management Systems)
     Quality System Requirements
•   Management responsibility       •   Planning of product realization
•   Management commitment           •   Design and development
•   Customer focus                  •   Purchasing
•   Quality policy                  •   Production and service
•   Planning                            provision
•   Responsibility, authority and   •   Control of monitoring and
    communication                       measuring devices
•   Management review               •   Customer-related processes
•   Provision of resources          •   Measurement, analysis and
•   Human resources                     improvement
•   Resource management             •   Monitoring and measurement
•   Infrastructure                  •   Control of nonconforming
                                        product
•   Work environment                •   Analysis of data
•   Product realization             •   Improvement
     Environmental Management

• The ISO 14000 family is primarily concerned
  with "environmental management". This
  means what the organization does to:
• - minimize harmful effects on the
  environment caused by its activities, and to
  - achieve continual improvement of its
  environmental performance.
       Obtaining Information
• By IMB website www.imb.ie
• By Medical Devices Information Packs
• By telephone or by e-mail with IMB at
  medicaldevices@imb.ie
• Useful websites e.g. EU Commission,
  MHRA, FDA
  – All links can be found at www.imb.ie
         Standards Information
•   http://www.nsai.ie
•   http://www.etci.ie
•   http://www.iec.ch
•   http://www.iso.ch
•   http://www.cenelec.org/
•   http://www.cenorm.be/