Ergebnisprotokoll by wanghonghx

VIEWS: 39 PAGES: 14

									                           
                               
                         NB-MED
                               
                          
                                                                                      NBM/038/ 06
                UNCONFIRMED DRAFT MI NUTES
           34TH MEETING OF NB -MED, 4TH AND 5TH APR IL 2006


1     WELCOME
The Chairman welcomed the participants, including the Commission representatives John Bren-
nan, Mr Catalani (medical devices) and Birgit Weidel (horizontal aspects) and gave apologies for
Mr Lacerda. He also pointed out that there was no Technical Secretariat for this meeting because
of contractual issues, and apologized for any consequent problems.

Because of attendance by different people, the order of the agenda would be adapted as neces-
sary.

John Brennan informs the NB’s of the change at the head of Cosmetics and medical device ( unit
F3) where Mrs Sabine Lecrenier has replaced Mr Carvalho.


2     GENERAL AND ORGANISATIONAL MATTERS

2.1   Roll call of the participants
Each participant presents itself mentioning the organisation represented.


2.2   Adoption of the draft agenda, supplements
(see NBM-013-06 )
An item about the Lübeck GHTF Conference was requested.by Mr Wallroth.


2.3   Approval of the minutes of the 33rd meeting of NB-MED
Document NBM-088-05 rev1 has been adopted with modifications raised during the meeting .
Mr Bos observes that on point 4.9 about classification of PACs: there was clarification of how
such a system might be Class IIb. However, since the last meeting, BfArM have made an inter-
pretation which may be in conflict.
NB-Med                                                                                 Draft Minutes


34. Meeting                                     2                             4th and 5th April 2006


2.4   Administrative questions: Update of NB official contacts and participants lists to NB-
      MED and NBRG
Mr Lambert remind the following duties of NB’s for good participation into MB-MED meetings
:
     - verify that the registration of the NB representative on the list is the correct oneif not get
         in touch with the administrative secretariat ( Mrs Terranova).
     - to have a single representative listed into CIRCA system registration is made by the ad-
         ministrative secretariat ( Mrs Terranova)
     - if the representative send an another person to the meeting he has to transfer on its own
         the invitation and the needed documents for the meeting.
     - volunteers to the NBRG meetings participation are requested to be registered on the cor-
         responding list held by the technical secretariat.
     - Works and quality of information exchanges can only progress if a sufficient number of
         notified bodies representatives are taking an active part to propose relevant topics, to
         write documents for discussion, to bring their expertise in the discussion .
In addition it has to be noted by all the participants that the funding of the NB-MED meetings
requires that
- A condition to participate on NB meetings is that a completed registration form was returned to
the administrative secretariat before the deadline.
- If participants have registered but are not able to participate, they are asked to notify the admin-
istrative secretariat about their cancellation one week before the meeting in order to keep in line
the costs of services with the effective use of participants. That points would be reminded by the
administrative secretariat with the invitation for the meeting.


2.5   Date and place of the next meetings of NB-MED, any other business
The next meeting would take place on 14 and 15 November 2006 in Brussels.
Dates of meetings for 2007 :
The proposals made by the chairman are accepted : 24th and 25th April 2007 - 13th and 14th
November 2007 in Brussels. Italian delegation mentions that 25th April 2007 is an holyday in
their country.

2.6 Next chairmanship
That point was discussed on the second day meeting. Due to his retirement end December 2006
Bernard Lambert was asking its colleagues to proceed with the designation for the Year 2007 of
a new chairman. He thanks Mrs Derdre Ni Bhroin for having assumed the function of vice-chair
and asked if she would be ready to pursue in that function. Mrs Bhroin announces that she will
not pursue the task so the question of vice-chairman may be discussed again in the next meeting.
As far as the chairmanship is concerned the discussion let appears that a candidate from South of
Europe would be welcomed and in the future from new joining Member States also.
Mr Lambert puts the question if there was volunteers to assume the chairmanship. From the floor
two names war suggested Mr Bos and Mr Worroll. Answering to the question Mr Bos from
Netherlands declares he was prepared to accept the duty with the consent of his manager. The
assembly confirms his designation by applauses.
John Worroll thanks the chairman for the work already done during the two last years.
NB-Med                                                                                  Draft Minutes


34. Meeting                                       3                            4th and 5th April 2006


2.7       New Approach revision
Presentation on the state of project and discussions by Birgit Weidel.from DG Enterprise

Mrs Weidel summarized the position, as in Certif 2005/16 2nd revision. (See NBM-025-06 joined
with the minutes)

She set out the main ideas which would lead to a proposal, probably for a Regulation, by the end
of 2006. The Regulation probably would not directly change existing Directives, but individual
Sectors would make their own decisions on any changes.

The exercise was necessary as there had been 25 years of New Approach and 25 Directives, lead-
ing to evolution and divergence over time. The main areas examined were:

      -    designation and monitoring of NB competence – more consistent and transparent proce-
           dures and more emphasis on post-notification surveillance are needed to increase confi-
           dence. It would be made explicit that NBs in all sectors should preserve confidentiality
           and respect the intellectual property rights of their clients. The view of the NBs was that
           the designation and monitoring should cover both QA and technical aspects of the NB
           competence
      -    The role of the accreditation bodies would be examined
      -    Market surveillance – this needs more focus with minimum Essential Requirements for
           national systems and extra cooperation between MS; the implementation of the Safeguard
           Clause could be streamlined
      -    There was consideration of expanding the scope of those addressed by the Directives to
           include importers and distributors, also to improve traceability to assist market surveil-
           lance
      -    Major changes are not expected in the Conformity Assessment modules, but an Inspec-
           tion Module is under consideration
      -    Activities subcontracted have to justify the independence aspect.
      -    The need for mandatory representation in the EU would depend from the sector

      New Approach (CERTIF 2005/16-rev2 bottom of page):
      http://europa.eu.int/comm/enterprise/newapproach/index_en.htm


3     REPORT OF NBRG (MEETINGS, ITEMS DEALT WITH, CHANGES IN MEM-
      BERSHIP)
Mr Worroll presents the minutes of the meeting held on 3rd April 2006.
See the minutes of NBRG (NBM-015-06). Any extra points or discussion arising during the
NBMED is recorded below.

3.1       Relationship to NBOG
(NBM-086-05, NBM-087-05)

Chairman will raise to the Commission the concern of NB’s on the use of GMDN regarding cer-
tificates.
NB-Med                                                                               Draft Minutes


34. Meeting                                    4                            4th and 5th April 2006




3.2   Role of NB in vigilance
(NBM-085-05 rev1 and)
Mr. Worroll apologizes Mr Rentschler which is absent for health reason. He recommends to send
comments on NBM-014 –06 to himself and Mr Rentschler before 21 April 2006 for communi-
cation to NBOG and Medical Devices Expert Group on Vigilance . It has to be reminded that the
NB’s have taken a position (refer to NBM-085-05 rev1).


3.3   Conformity Assessment of Own Brand Labelling
(NBRG/301/05)

The latest draft from Mrs Williams have to be commented by everybody up to 21 April 2006
allowing to transfer the document for the next meeting of NBOG in next June.

3.4   Renewal of EC Design and Type Examination Certificates
(NBM-086-05)

No new development . Wait for information coming from NBOG.

3.5   Certificates issued by Notified Bodies
(NBM-087-05)

The impact of GMDN on the management and registration of certificates has been underlines by
Mr Worroll as a result of the NBRG discussions. The Commission would be informed of our
concern.

3.6   E-Labelling
Waiting for a proposal from Mr Rueda.

3.7   Consultation procedure with Competent Authority , EMEA or Advanced therapies
      Committee
(NBM-016-06)
Mr Pirovano puts the question to know in which circumstances the document on drug eluting
stents have been issued by the Committee for Human Medicinal Products under the EMEA.
In particular he wants to understand under which mandate the document was issued.
Mr Bos brought the concern that the situation created could lead to confusion with the role of the
competent authority on the national level .
John Brennan observes that the matter was examined from the clinical point of vue and he will
try to get information on the origin of the consultation.
Mr Pirovano insist on the need to have a reaction on two aspects: first the consultation process is
not in line with the provisions set up in the directive 93/42/EEC for medical devices incorporat-
ing a medicinal substance, secondly the way the NB’S will comment on the document within the
time frame of the 31 May 2006.As a matter of fact the document have been recently circulated
into NBRG and have to be circulated via circa.
NB-Med                                                                               Draft Minutes


34. Meeting                                    5                            4th and 5th April 2006


Mr Lambert mentions the letter ( NBM-003-06) sent to the Commission for claiming a metho-
dology for consulting the EMEA in the case of medical devices with blood derivates or human
engineered tissues . The answer of the Commission (NBM-004-06) has been distributed to the
NB’s and refers to the procedure of medicinal substances as described in Meddev 2.1/3 rev 2.
NB’s have also observed the progress of the advanced therapy regulation for which they want to
preserve the role of notified bodies as expert on the evaluation of medical device aspects.
Mr Howlett draw the attention to possible overlapping of works between Clinical Evaluation
Task Force and CHMP committee on the drug eluting stents subject.


3.8    Change of Notified Bodies
(NBM-024-05)

Wait for NBOG last version . No further action is required for the moment.


4     TECHNICAL ISSUES RELATED WITH DEVICES (ENQUIRIES AND CONSEN-
      SUS STATEMENTS)

4.1    Regulatory issues raised by members for harmonization (medical device status,
       classification, interpretation of rules, assessment or audit problems, …)
Weighing Instruments

(NBM-007-06 rev1 , NBM-011-06)

There is an inquiry NBM-009-06 about weighing instruments for patient. That point was not ex-
amined by the NBRG because of other matters. The point is to determine whether patient weigh-
ing scales are medical devices, are body mass index calculators medical devices, patient scales
including body mass index calculators are medical devices. One competent authority considers
that a weighing scale with no other function on the patient weighing should refers to the non-
automatic weighing instruments directive and woul not be considered as a medical device re-
gardless of the intended environment. Some competent authorities consider the addition of body
mass index may make it a medical device. It is decided to consult the border line working group
to gather the view of the member states. The discussion indicates that Germany considers the non
–automatic weighing instrument regulation for the first aspect of the question, the second and the
third aspect which could be thought as therapy products and then considered as medical devices
but there are still discussions. The final status depends from the claims of the manufacturer.
Dutch authorities looks in addition how they are selling the product ., on the regular market they
are not medical devices , a very small part with formal claim for medical purpose may be a med-
ical device. In fact the problem is not for the home use but if it is specifically sold to weighen
patient in clinical site. In UK if it does a medical purpose then it is a medical device, the single
function of weighing patient is not a medical device but with addition of weighing fat or other
body index it is a medical device.
There was also pointed out the patient weight might be an important indicator in the loose or not
of water weight and gives indication for adjusting the medication and the treatment.

Action: ask to the Commission to get a consensus from the borderline group on weighing scales
on basis of an English abstract explaining the second and third aspect of the question .
NB-Med                                                                                  Draft Minutes


34. Meeting                                      6                             4th and 5th April 2006




IEC 60 601-1:2005 standard

(see document NBM-010-06 and Dratf proposal NBM-011-06 to be circulated for comments)

A question has been raised by Mr Hines in the context of risk management reference in the 3rd
edition of IEC 60 601-1:2005, there was not time to discuss the matter in NBRG and the prob-
lem has been evoked in the Team NB meeting which concluded that the understanding of NB’s
would be expressed in reaction to the publication on the article of Mr Rudolph and Siddebottom.
The article which has been circulated was partly written by TC 62 secretary who was responsible
for writing the 3rd edition standard and the question was the concern of prohibiting third party
certifiers from questioning the results of risk assessment. That point is related to the testing to the
standard because in many products the risk assessment to the standard may also be a majority of
what might be considered in the technical file itself and the principle not being able to question
the risk assessment is against normal operating practice where everything is open to question.

Action: let circulate documents , ask for comments, NB’s position to be sent to the editor.




5     COHERENT APPLICATION OF DIRECTIVES (RECOMMENDATIONS)




5.1   Audit report content

(GHTF / SG4/N30R16: 2005 and NBM-008-06)

The objective was to make observation to support the maintaining of type-examination module
which is in the European medical device directive. In fact there was comments asked by Cana-
dian authority which are active in the GHTF and there was also a formal inquiry coming from
the GHTF itself. The chairman has made the comment for keeping the module in the frame of
GHTF recommendation.
John Worroll who participates to the GHTF, mentions that it might be worse reporting on the
results of those comments , the subject being controversial.
NB-Med                                                                                Draft Minutes


34. Meeting                                     7                            4th and 5th April 2006


5.2     Implementation of Directive 2005/50

(NBRG-303-06)

John Worroll resumes the discussions in NBRG with two representatives of the orthopaedic in-
dustry. The points exchanged were focused on :
    - the experience already gained by NB’s in design examination for class II products,
    - the points which are not in line with the directive text for example :abbreviated EC design
        evaluation , letter of intent or conditional certification, design dossier have to be distin-
        guished from technical dossier, time frame and modus operandi to be agreed by the par-
        ties and need for manufacturers to have a provisional plan to getting on time certificates.
Mr Pirovano underlines the realities of manufacturers in short terms : the high number of files,
the existence of old products on the markets since 30 years, the risk of withdraw from the market,
the amount of information to be gathered, the need for finding solutions in a reasonable way.

John Brennan expressed the views of the Commission saying that the directive only classify up in
class III the concerned prosthesis, and the guidance will not change the regulatory implementa-
tion of directive 2005/50, neither the way of functioning of NB’s or the expectations of the com-
petent authorities. The change in the classification will reinforce the design evaluation required
for implantable devices.
Mr Brennan takes note of the demand from industry for cooperation with member states but re-
quires from the manufacturers clear and concrete points demonstrating the need of discussing a
guidance for the implementation of the directive.


6     INFORMATION FROM LEGAL ADMINISTRATION AND COMPETENT AU-
      THORITIES

6.1     Development of directives

6.1.1    Medical devices directive revision


(NBM-009-06)

J. Brennan presents the state of discussions within the revision of directive 93/42/EEC; the pro-
posal of the Commission was issued on 22 December 2005. There was already about 5 meetings
in the Council and the objective is to obtain a political agreement for the next Counci of Health
ministers in June under the Austrian presidency. The discussions are also linked with New Ap-
proach revision and the advanced therapy draft regulation, both item may have influence on the
final adoption.
The Parliament have to start with the discussion within two months; it is expected that the re-
vised directive would be adopted in the beginning of 2007.The European Economic and Social
Commitee is also consulted and Mr Braghin from Italian Cofindustria industry representative is
the rapporteur assisted by Mr Pirovano as medical device expert. It is intended to issue the
Committee opinion for mi-May 2006.
Mr Verdonck underlines the concern of industry on the actual text of the revision which compris-
es elements producing new impacts.the Commission defend its proposalon custom made devices.
NB-Med                                                                              Draft Minutes


34. Meeting                                        8                       4th and 5th April 2006


Mr Pirovano express the view that there is a contradictory overlapping between MDD 93/42/EEC
and the project of regulation on advanced therapy products, considering that NB’s have the skill
to treat medical devices comprising as an ancillary action engineered tissues.
Mr Lambert mentions the action of NB’s the rapporteur in Parliament Mr Mikolasik on the last
subject.
Nanomedicines products are not covered by the advanced therapy draft regulation.



6.1.2   Directive 2005/50


The presumed difficulties of implementation on the reclassification of joint replacement of hip,
knee or shoulder prosthesis has been already examined in point 5.2 reporting about the work of
NBRG.
Mr Lambert remind its proposal made during the last MDEG meeting to have the possibility of
opening common approach between manufacturers , NB’s and some Members States representa-
tives on the implementation of the directive.

6.1.3   Directive on Advanced Therapies


(NBM-017-06 and NBM-018-06)

Mr Lambert give a brief overview on the advanced therapy regulation actually drafted ( see
NBM-018-06).
The powerpoint presentation is annexed to the minutes.(NBM-017-06).
EMEA would be the decision maker of the product market authorization.

6.1.4   Directive on electric / electronic waste


No new development have been registered on that directive since last NB-MED meeting.

6.1.5   RoHS directive
 On the subject of hazardous substances the DG G4 have sent an invitation for a representative of
NB’s to the presentation of the interim report to be made during the expert workshop of 26 April
2006.
Mr Verdonck from Eucomed indicates that he will go to that meeting for its organization.
Mr Lambert ask for an information back to the NB-MED.


6.1.6   Other directives impacting medical devices
John Brennan draw our attention to the final revision of directive “machines” from which elec-
trical and electronic machines were up to now excluded. The changes in the directive will make
no exceptions so that the medical devices may fall under the directive.
It was suggested after discussion that a sentence will be added to the MDD giving the status of a
specific directive as it is used with respect to the personnel protective equipments directive.
NB-Med                                                                              Draft Minutes


34. Meeting                                    9                           4th and 5th April 2006


6.2     Competent Authorities works

6.2.1    Senior Officials meeting


(NBM-020-06 , NBM-021-06, NBM-022-06, NBM-023-06, NBM-024-06)

The Senior Officials Group on standardization meets regularly and the last edition was on 30
January 2006 . Among the subjects which are debated, there are several documents related to the
internal market completion and which might impact the NB role . These documents are joined to
the minutes for the information of NB’s and are concerning:
    - market surveillance CERTIF 2005-7 draft
    - role and significance of CE marking CERTIF 2005- 11
    - community accreditation policy CERTIF 2005-12
    - designation of NB CERTIF 2005-3 and 4


6.2.2    WG on nanotechnology


(NBM-019-06)

Report from meeting on 29 March 2006 was given by Mr Wetzel. The points examined were
focused on adequacy of MD existing regulations (including IVD) with nanotechnology develop-
ment, need for specific risk analysis, borderline issues, examples of MD utilizing nanotechnolo-
gies, classification issues.
The document NBM-019 -06 is joined to the minutes .


6.2.3    WG Notified Bodies Operation Group


The next NBOG meeting would be held in conjunction with MSOG meeting in June 2006.

6.2.4    Working group IVD
The IVD technical Group last meeting on 08 February 2006 has discussed two main topics the
revision of CTS in which list B product should enter later on, and the classification of genetic
testing. Definition of rapid test and limits of performance are also considered. John Brennan is
collecting comments on the amended CTS document which could be ready for end of 2006.


6.3      MDEG
The MDEG meeting has taken place on 28 March 2006 after a break of 8 months. The Clinical
Evaluation Task Force is working on a guide for stents incorporating active principles drugs and
in GHTF clinical evaluation discussions have started. The Working Group on vigilance will meet
in May. The next meeting would be in autumn.
On teeth bleaching products no decision has been taken for the moment, the opinion of scientific
committee would be asked to define the borderline with the cosmetic directive.
NB-Med                                                                              Draft Minutes


34. Meeting                                   10                           4th and 5th April 2006


6.4   GMDN
The objective is to have a database implemented for facilitating the cooperation between the
Member States .
Mr Catalani refers to the progress made end of last year in the management of the maintaining
agency which have adapted its website and which easily accessible on www.gmdn.org



7     GLOBAL HARMONIZATION AND INTERNATIONAL RELATIONS

7.1   Status of Global Harmonisation/GH Taskforce (GHTF)

GHTF/Study Group 1 “Regulatory Requirements”


Johann Rader told the meeting take place in Sydney during 4 days , last week.
Two documents were examined :
- classification of medical devices
 - conformity assessment for medical devices

Both documents have been on GHTF website as proposed drafts for several months , 81 com-
ments were received for classification, all comments have been discussed , and an agreement has
been reached. ,The major debate was about the classification of X-ray diagnostic equipment. Ja-
pan was in favour of down classification from C to B. Mr Jeffery consider that equipment as
dangerous technology. At the end the concerned equipment remain in C but with opening clause
saying that some jurisdiction may on certain conditions allow class B .
Other comments could clarify the document which is with a highly degree identical to what we
have in Europe, there are some minor variations like blood bags and surgical instruments.
The document is addressed to the steering committee and would be put on the website as final
document.

The other document discussed was principle of conformity assessment for medical devices which
was also a proposed document. 63 comments were received and one third was about the subject
type-examination which was challenged by some parties. Europe and Australia are in favour of
type-examination . Strong opposition comes from Canada, FDA and Japan. The end point is to
have a text saying that type–examination could replace the design control part of the quality sys-
tem which could be justified in cases where the product existing already in its design when the
quality system was put in place because it is ridiculous to retrospectively create quality system
documents for product already designed many years ago.
Type–examination will not appear in the tables of the conformity assessment modules, the pre-
ferred route remains the quality assurance with the design dossier where appropriate, but as a
compromise type-examination will refers to an option in a limited case.
Product verification as an option to replace a production quality system has been noted for a dis-
cussion in the next meeting and for the revision of the document. The product verification case
may be useful for product in the research . Mr Bos gives comment for the next discussion dealing
with authorities getting more and more structured hospital and identifying some product which
was not CE marked because nobody realise that they might be medical devices. They were
forced to get off the market and the only solution was to make a product verification on a batch
NB-Med                                                                               Draft Minutes


34. Meeting                                   11                            4th and 5th April 2006


level .The document is addressed to the steering committee and would be put on the website as
final document.

Mr Kexel comments on the interest of preserving such an option in the system for small and me-
dium companies. Mr Lambert agree on the view expressed but points out the dual situation in the
regulatory field : the European regulation which permit the use of various modules and the inter-
national situation which sometimes takes a diverging orientation . Mr Rader indicates that the
compromise was the result of a strong fight. Mr Wallroth adds that the major objection coming
from US industry is the misuse of the concept by China , they mandate the type-examination for
any product entering the market but the reason for that is to keep their 60 000 test engineers busy
so the document make clear that it is only an option for the manufacturer but cannot be an option
for regulator. The Australian representative mentions a list of companies using type-examination
in which there was manufacturers from all over the world. It was also confirmed that 3 to 6 % of
certification are type–examination certificates and they gather also product verification certifi-
cates. The way it is written now is a transient option only for existing products. The trend for
quality system is strong in USA , Canada and Japon.

.
GHTF/Study Group 2 “vigilance – pms”

Mr Wallroth gives a report on the meeting held in Niasaki in Japan.
The group is oriented on the exchange of vigilance information.
The revision of adverse event was discussed and Mr Stösslein have brought some change in the
wording of definition in line with the Meddev document.
The GHTF revision and the European revision would be done in parallel. The frequency may fall
from 3 to once a year to maintain the documents and the vigilance exchange.
They organizes the vigilance report exchange, the topics are more administrative scheme for
exchanging information, they have a listing of how much adverse event reported rules have been
implemented on worldwide scale, there is also discussions about Japan which not accept medical
device stopping their function and sounding an alarm as specified in the national standard like
for ventilators, they consider this as a reportable event.



GHTF/Study Group 3 “quality systems”


There was no report on this group for which the objective remains the guidance on risk manage-
ment aspects within the quality management system audits



GHTF/Study Group 4 “Auditing”

The last meeting was held in Taiwan in February and the major items addressed were comments
on the Audit Strategy and the Audit Report documents. Canada entered major comments on the
Audit Strategy documents, including:
     It is too much based on the FDA QSIT model
NB-Med                                                                            Draft Minutes


34. Meeting                                   12                         4th and 5th April 2006


      There is confusion between “conformity” and “compliance”
      There is confusion in the logic and terminology of the document between “systems” and
       processes”. The quality system may be broken into subsystems and these may (or should)
       be audited by the “process approach”.

John Worroll gave his opinion that the document had been improved by the discussion of these
points, especially in respect of the third one. However, because of the Canadian view that some
of these comments may not have been sufficiently addressed, there has been a post-meeting
email discussion about whether the document should proceed to the next stage – at the moment it
seems likely that it will.

John Worroll also questioned withdrawal of the document on observed audits which had been
agreed at the Lubeck meeting which took place in 2005 but which Mr Worroll had not attended.
After discussion, it was agreed to reinstate the document as it continued to be useful to CABs
who are increasingly subject to shadow audits by DAs.

The next meeting will be in Lûbeck in June.


GHTF/Study Group 5 “Clinical evaluation”

There was no specific report.This group is oriented on harmonized guidance for clinical evalua-
tion and works on definitions and concepts.


GHTF Conference in Lübeck 28 June 2006

Mr Wallroth mentions they have set up a 15 people team to manage the Conference and gives an
the latest updated programme.
The programme, the hotel booking information, the registration form, information for coming in
Lübeck are available on the website www.ghtf.org
Hotel reservations were supposed to be done for end March , a negotiation with the majority of
hotels have permitted to obtain an extension up to end April 2006. There is still 154 rooms
available. People have to negotiate directly with the Hotels asking for the GHTF rate. About 15
persons in the room are already registered to the conference.
Documents for the conference will be added to the meeting minutes.See NBM 026-06 up to NB-
30-06)
GHTF conference gives also the possibility to present a poster, the chairman of the group being
Dr Stösslein ( BfArM) , the abstract should be 200 word and be linked with GHTF regulatory
objectives. It is also an opportunity to represent the NB group at the international level.
Concerning the workshops it is mentioned that there is a limitation of 50 persons for each and
two of them are already booked out namely : technical documentation and risk management.
NB-Med                                                                                   Draft Minutes


34. Meeting                                      13                            4th and 5th April 2006


7.2   Progress on MRA

Discussions between Europe and Australia for the renewal of the MRA agreement are going on .
In the agreement there would be included a clause concerning the rule of Origin in order to limit
the use of Australian CAB by foreign countries for entering into the European market. The list
of CAB will be updated due to the changes occurred since the beginning of the agreement and
also for taking into account the enlargement of Europe. The Member States have to complete the
designation of CAB as necessary.
Taking in consideration the discussion between Australia and New Zealand for setting up a
common Agency, the agreement would also be extended to New Zealand who is also involved
in a similar MRA .


8     STANDARDIZATION

Mr Catalani mentions the useful websites:

Harmonised standards:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

Mandates database:
http://europa.eu.int/comm/enterprise/standards_policy/mandates/index.htm




8.1   Mandates
Mr Catalani report on the EC Commission standardization mandates and remind that the man-
dates are managed by the standardization unit in DG Entreprise.
Coming from the IVD WG a mandate has been given to CEN to elaborate a European standards
on colour codes for IVD receptacles.
 About the mandate 305 concerning protection of people from magnetic field where medical de-
vices are excluded it has been asked to check if there was no intention of modifying it.
The commission bears also attention to maintain consistency and coherence in the management
of standardization.
Publication of standards are mentioned in the DG enterprise website a new policy for publication
revised standards would be applied. Mr Rueda ask for indicating also the first date of publication
The initiative of CEN to revitalize the health sector approach in cooperation with CENELEC
and ETSI has been welcomed.
NB-Med                                                                                Draft Minutes


34. Meeting                                    14                           4th and 5th April 2006


8.2   Advisory Board for Healthcare Standards

(NBM-006-06)

The Advisory Board for Healthcare Standards have met for first time on 16 March 2006.
ABHS replaces the CEN healthcare forum and is chaired by Mr Phelps and have the purpose to
consolidate the cooperation between standards organisation in the field of health , to orientate the
strategy for standardisation programme according to the needed priorities identified in health-
care, to recommend and support the works to be developed in the health area.
The report of the meeting is joined to the minutes.

8.3   Healthcare Technology Task Force
(NBM-006-06)

Under the aegis of ISO a platform for World Standards Cooperation in the Heath sector has been
set up . The report giving recommendation to concerned standardisation bodies have been issued
in January 2006 and circulated for information of stakeholders on Circa.


9     OTHERS

The relationship with Taïwan has been raised by mr Jepson.
Mr Lambert mentions there would be a workshop end august 2006 with the purpose to inform
Taïwanese on the MD CE marking legislation as an exchange of information. He was asked to
talk about the clinical evaluation. He also remind the particular commercial and political context
in which the partnership between 11 NB’s and 4 Taïwanese Bodies has been built. The designat-
ed Bodies are those who have fulfill an observed audit by Taïwanese representatives.
It is a lighted procedure which permit the endorsement of audit report on ISO 13485 including
the NB cover letter , the CE certificate and the governmental free sales certificate.
Some difficulties for having access to the allievated procedure for manufacturer from EFTA
countries occurs recently. Mr Lambert have approached his contact in Taïwan trying to explain
that CE marking is a joint cooperation between European Union and EFTA since the origin of
MD directives and therefore it would be better to give the same access for EFTA manufacturers
certified by NB’s Partners of the agreement. The decision is pending.

PS: few days after the meeting a complementary information indicating that Swissmedic is ne-
gotiating with Taïwan since April 2005 an arrangement could be reached in the next months.

								
To top