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					EUROM VI-COCIR-EUCOMED-EDMA-CENELEC-NB-MED-EUROMCONTACT-FIDE Participant’s Meeting Report
EU Medical Devices Expert Group Meeting                                                                                         ISM 2003-51
Brussels / October 27 and 28, 2003                                                                                              Nov 4, 2003
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Participants
                                                                                                                                        NBM/017/04

62 delegates from AT, BE, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GR, HU, IR, IT, LX, MT, NL, NO, PT, SE,
SL, TR, UK, CENELEC, COCIR, EUCOMED, EUROMCONTACT, FIDE, EUROM VI
__________________________________________________________________________________________
Distribution
NARK 3.1, 3.2, 3.3, 3.6 via
Ms. Dr. V. Sattelmayer, DIN

K 810, K 812, K 812.3 & K 812.8 via
Dr. K. Neuder, DKE

EUROM VI / SPECTARIS members via
Mr. M. Wenzel, SPECTARIS

FIDE members via
Mr. D. Bellwinkel

COCIR members via
Mr. G. Strattner

ZVEI members via
Mr. A. Schröder

CENELEC TC 62 members via
Mr. C. Duncombe, BSI

EDMA members via
Ms. Christine Tarrajat / Ms. Howes

EUCOMED members via
Mr. R. Moore / Mr. D. Pirovano

EMIG WG members via
Mr. G. Strattner

NB-MED members via
Dr. H. Dinkler

Prof. Dr. H. Frankenberger, FHL / NARK 3
Dr. G. Fusato, UNI, IT / CEN TC 215/WG3
Dr. D. Peel, Ashdown Consultants, GB / CEN TC 215/WG3
Dr. P. Thompson, CEN CS, Brussels
Prof. Dr. E. Schwanbom, FHL / NARK 3.3
Mr. R. Virefleau, CEN CS, Brussels
Ms. K. Howes, CEC DG ENTR.
Mr. J.C. Pitres, AFNOR / CEN TC 215/WG2
Dr. T. Phelps, BSI / CEN TC 215/WG4
Dr. A. Lacerda, CEC DG ENTR.
Mr. C. Brekelmans, CEC DG ENTR
Mr. N. Anselmann, CEC DG ENTR.
Mr. H. Seitsonen, CEC DG ENTR.
Dr. E. Stösslein, BfArM
Dr. G. Schorn, BMGSS
Mr. H.G. Will, BMGSS
Mr. W. Reischl, BMGSS
Dr. U. Soltau, ZLG
Mr. J. Michalicek, AU
Mr. M. Ballereau, AFSSAPS

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Mr. J.C. Ghishlain, AFSSAPS
Dr. S. Mieke, PTB
Mr. R. Voelksen, Swissmedic
Mr. M. Freeman, MTC, Oxford
Mr. W. Higgins, CEC
Mr. M. Frellsen, DMA
Dr. R. Holland, NIOM
Mr. P. Samanides, CEN
Dr. W. Ecker, AT
Mr. P. Höfer, EUROMCONTACT
Mr. H.M. Tillotson, EUROMCONTACT
Dr. J. Rader, TÜV Product Service
Mr. H. Rentschler, mdc
Dr. K. Höxer, LGA
Mr. J. Bay, Gruner, CH
Mr. H. Junker, DE
Mr. P. Schmidt-Andersen, DK
Ms. Xiaoli Ren, TÜV Rheinland (Shanghai)
Mr. Yan Liang, SPAB, Shanghai
Prof. A. Dolan, ISO TC 210
Mr. P. Carstensen, FDA/IEC 62 A WG 5
Dr. M. Bazaral, FDA
Mr. G. Welyczko, US
Mr. M. Graber, Datex-Ohmeda/IEC 62 A WG 5
Dr. M. Weinger, UCSD / AAMI HFE
Mr. J. Nordan, Norway
Mr. A. Fields, NKKN
Mr. P. Rattke, MED-EL Medical Electronics
Mr. H. Thiemann, DMI
Dr. W. Reim, DW, Kst. 8015
Dr. P. Gebhadt, DW, Kst. 4130
Mr. F. Clanzett, DW, Kst. 4130
Mr. B. König, DW, Kst. 4020
Mr. H. Alt, DW, Kst. 8210
__________________________________________________________________________________________
Address
Albert Borchette
B-1040 Brussels
__________________________________________________________________________________________
Place / Date
Brussels / October 27 and 28, 2003
__________________________________________________________________________________________
Subject
EU Medical Devices Expert Group Meeting
__________________________________________________________________________________________

President:             Dr. Antonio Lacerda, CEC

Secretary:             Mr. Hannu Seitsonen, CEC

Participants:          61 delegates from AT, BE, CH, CZ, DE, DK, EE, ES, FI, FR, GR, HU, IR, IT, LX, MALTA,
                       NL, NO, PT, SE, SL, TR, UK, CENELEC, COCIR, EUCOMED, EUROMCONTACT, FIDE,
                       EUROM VI

0.         Executive Summary

           The Medical Devices Expert Group met October 27 an d 28, 2003 in Brussels with the following
           results.

                 Global Harmonization Task Force GHTF

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                  Preparation of the Steering Committee SC meeting San Francisco November 2003
                  Status of documents:
                  - information, source, status documents, e.g. on tissue engineering
                  - guidance documents (on best regulatory practice)
                  - implementation documents (recommended for coherent implementation of common
                      regulatory elements).

                  Industry request for score cards led to debate on document status.
                  Score card could be replaced by industry statement if system works or not.
                  NL. DE warned against implementation documents outside the regulatory framework. Europe
                  implemented the vigilance guidance as MEDDEV; this group of documents should be kept per
                  CH, EUROM VI, UK- common forms, AT ditto in the procedures, EUCOMED, FR –
                  recommended for implementation, COCIR – needed by industry and for outside countries, UK –
                  only to simplify procedures, M.F. – JA, CA, AU have already implement GHTF documents. CEC
                  concluded to argue for information and guidance documents.
                  Rapporteur from industry and regulators.
                  Progress sheet for GHTF documents.
                  SC activities to be reviewed.
                  Common data: QS, pre-clinical and clinical, demonstration of conformity with EP, usability,
                  registration of manufacturers and medical devices.
                  Harmonize standards and supporting...
                  Exchange and sharing of data.
                  Promoting projects for these goals: SG 4 – exchange of audit reports, SG 1 – clinical data,
                  registration, design evaluation.

                  European Chair 2004-2006
                  Review of Ottawa rules
                  Implementation of current priorities. i.e. STED.
                  Enhancing patient safety.
                  Meetings of SC and GHTF conference.
                  Membership on SC and SG: rotary participation of EU regulators in SC.
                  Enhancing patient safety – unifying scheme on revised vision for 2004-2006.
                  - designing for patient safety
                  - ensuring the safe use of medical software
                  - handling of new technologies: tissue engineering, pharmacogenetic testing, etc.
                  - global vigilance reporting NCAR, common form, WHO interest in participation.
                  DE: demonstration of efficacy to be added, i.e. safety and performance, to be considered in
                  addition.
                  GHTF conference: June 2006, Lübeck, global conference.
                  Regional conferences as needed and ASEHA, Latin America, China, WHO, Europe.
                  Lübeck was offered by European industry, C.B. did see premises, look interesting.
                  SC meetings:
                  June 04 FR, May 05 Sevilla, ES, November 05 UK, June 06 Lübeck, November 06 Brussels.
                  Members states could make offers e.g. for 05 Sevilla.

                  Study Group Progress reports
                  SG 1 regulatory systems, M.F.: definitions of medical device, principles of classification, STED to
                  become proposed documents, role of standards including IVDs ditto, essential principles including
                  IVDs ditto. Commission received a bible of documents for the SC meeting, being made available
                  via the CIRCA. MDEG supports publication on the web for three month consultation, need for
                  progress sheet reemphasized.
                  SG2 vigilance: reporting of use errors, universal data set already endorsed by MDEG earlier as
                  final document. N 54 adverse event reporting rules compilation of several approved documents.
                  SG 3 quality systems:
                  QMS and risk management, design control and process validation subcontracting draft. QMS and
                  risk management integration: EUROM VI concern about SG 3 and ISO TC 210 developing
                  overlapping (or even contradicting) guidance. Premeeting of European members in SC to explore
                  the status of this document, if preliminary draft or proposed document and then to develop a
                  European position. Design control – cosmetic change over previous final document: document not
                  being available, ergo European position before SC meeting.

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                  Process validation – ditto.
                  SG 4 auditing: auditing general requirements to be reviewed in light of new ISO 13485:2003
                  QMS standard; new proposed document on regulatory auditing strategy, new work item on audit
                  report. – EU pre-meeting to establish status of documents.

               Reclassification of total joint implants – state of play (info only)
                Update by the Commission; ES document was tabled; CA-only meeting with the Commission is
                planned. Complaint by DE about slow progress. EUCOMED: clarification that industry never
                agreed on the proposal. Meeting in the 2nd half of November 2003, Member States to put forward
                final position at that meeting.

               International relations
                China – state of play
                Meeting with the Commission planned for next week was deferred to next year. Commission has
                forwarded to China. European industry complains on Chinese market access. Invitation for
                preparatory meeting in due time. Medical devices were not yet on the agenda for next week’s
                meeting.

                  Chinese Taipei – state of play
                  EUCOMED is developing a pilot project following exchange of letters between Taipei and CEC
                  for the 15 members states. Request for certification of NB certificates by CA monitoring such NB
                  was turned down by the Commission. EU industry delegation to Taipei under consideration.
                  Chinese Taipei authorities to be invited for March 2004. No need to endorse because Competent
                  Authorities are free to do what they feel competent to do. FIDE: new 2004 regulation requires
                  unjustified information from manufacturers e.g. on work shop and machine plans. NL: ditto: from
                  CAs about their competence. EUCOMED got some positive feedback from Taipei delegation
                  visiting some weeks ago. Chair took silence of this group as concurrence.

               EU-accession countries: workshop on vigilance and market surveillance (Brussels, December
                4-5, 2003)
                Cochaired by Nicolas Pallikaris and Hector Costa. Meeting room facilities at Centre de
                Conférences A. Borschette – rue Froissart – 10-40 Brussels
                December 4 : vigilance, December 5 : market surveillance. Speakers have been identified and will
                be notified this week. Accessing countries can bring three persons with Apex tickets (Paid for
                three) and hotels paid for two because vigilance working group will meet December 3, 2003.
                Plan A: reception at the IT embassy. Q and A session? Reception with industry meeting regulators:
                EUCOMED sponsorship was welcomed by the chair.

               GMDN - EUDAMED progress report
                Translation funding into 10 EU languages is much higher than expected and needs high level
                clearance and might need to be done by priorities. EUDAMED WG Oct 7, 2003: feedback from
                about 11 member states, conclusions available on CIRCA site plus tabeled copy because
                Commission had difficulties with CIRCA access.
                GMDN progress report by M.F. about maintenance agency policy group meeting in London 29
                and 30 September. Quality control issues about maintenance and synchronization of multiple
                language translation. Copyright issues remain as well as user charges. CAs receive free copies but
                are not free to circulate it.
                Subcategories: first meeting of CEN TC 257 WG in Helsinki on September 15, 2003 for subgroup
                to start work November 17, 2003 in Paris for first draft by new year. Subcategory copyrights
                should not be an issue.

               BSE/TSE – reactivation and future work of working group
                Commission has no human resources for reactivation. About 200 medical devices with animal
                tissues. CA to evaluate SER in 12 weeks. EDMA and EUCOMED concerns to the steering
                committee. Commission’s plan for January 2004 considered too late, ergo in November after CA
                meeting invitation by or around Wednesday.

               Progress reports of last Working Groups and Task Forces meetings
               IVD Boarderline


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                  Report by J.K. on draft MEDDEV. UK opposed to gen chip examples to exempt military activity.
                  IR: removal of products for research only, application of biocide directive unclear. Document to be
                  revised.

               IVD Annex II
                Report by FR. End 2004 revision of TS? Combination with IVD boarderline? HIV kits to be
                discussed in IVD boarderline for software. Nuclear activation kits for HIV: more time needed. In
                house manufacturing on todays agenda. Majority of CAs not in favour of IVD only MDEG
                meetings. WHO is drafting standard of hepatitis B; bilateral agreement between WHO and
                Commission, meeting 20 Oct. : WHO will not publish without consultation of the Commission;
                Commission to participate in WHO Jan. 2004 meeting. Combination of Annex II and IVD
                boarderline meeting ok.

               NBOG
                Report by S.O.: NBOG work program substantially completed, 3 of 30 work items still pending.
                New work program for January 2004 CA meeting. MBOG annual report 2002 found great interest,
                therefore 2003 report for website presentation planned. NB-MED Chris Jepsen to participate, first
                contact on Wednesday.
                J.K.: NBOG to dissolve itself. S.O.: NBOG work items endorsed by CA group. EUCOMED
                enthusiastic about NBOG work. S.O.: NB-MED to be invited to speak for NBs and industry.
                NBOG to work with NB-MED and industry.

               MSOG
                Report by PT representative: class I, annex VII and VIII, inspection, criteria for distributors,
                miracel cure products addressed. Opening of the MSOG meeting for informal NB and industry
                contacts to be discussed with chair Hector Costa when present. Document on custom made devices
                and dentistry is being addressed.

                  Transparency
                  Meeting on 16 Oct. 2003, supposedly the last one. EUCOMED drafted proposal for pilot on class
                  III devices including IVDs. Proposal to be redrafted for five examples for December 3, 2003
                  meeting. English performed language.

                  Workshop EU – accession countries Budapest July 2003
                  Good meeting. Ten of 13 accession countries attended, one of the three missing was not funded.

                  Tooth whitener
                  Ruling of a lower court in DE in opposition of high court ruling in the UK;
                  DE: MD, UK: cosmetics. Consumer protection might apply when a product is not considered to
                  treat illness: Mr. Cavallo, CEC cosmetic directive. Peroxide content links tooth whitener to
                  cosmetic directive. If content above 6 % situation becomes unclear. UK position: concentration
                  secondary issue, principal intended purpose, i.e. cosmetic to bleech teeth, complicated also from
                  obelescence (?) claim. Therefore banned from the UK market per house court ruling.
                  DE CA position: also not an MD but more a cosmetic product (below 6%), above unclear;
                  therefore unhappy about DE court ruling, based on weakness in MD regulation. Court followed the
                  argument that patients with black or bad teeth are under ‘leidensdruck’, i.e. suffering.
                  Amendments of MPG considered but difficult under DE court ruling. Some relief because
                  normally only applied under the direction of a dentist. PT: even 40 % products on the market, but
                  exclusively used by dentists. NL: CE marked = cosmetic, high concentration = pharmaceutical raw
                  material; products banned.
                  SE court case: legal procedure to apply CE mark was legally correct in DE.
                  BE: agrees with UK position.
                  IR: cosmetic products, recently MD certificate removed, planning to take CE marked products
                  from the market.
                  HU: not medical device, share UK position.
                  IT: higher than 6 % only for professional use.
                  FR: below 6 % cosmetic, above product safety directive could apply.
                  FIDE: cosmetic under 3 %, up to 15 % for home bleeching without danger of teeth flesh. Up to 40
                  % only for professional use with black teeth opened by the dentist. Dentist can mix it himself,


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                  without control; buy on ebay without control; buy it under the counter, e.g. in UK, without
                  control; or: class IIa MD as in DE with control.
                  EUCOMED: customer safety for products available freely or used by professional.
                  DE: risk control is covered; this group does not consider it MD, but court ruled otherwise.
                  Commission should bring manufacturer to court. Chair: this group cannot decide on other
                  denomination of a product. Mr. Cavallo: 0,1 % max. H2O2 concentration per cosmetic directive
                  (actually 0,3 %), higher is illegal; not lawful unless it is proved that it is safe.
                  EUROMCONTACT: cosmetic directive revision to cover eyes? If so contact lenses to change eye
                  colour to be included? Answer: do not know.
                  Chair: this group does not consider tooth whitener as medical devices regardless of H 2O2
                  concentration.
                  FIDE: companies follow MDD with class IIa in line with social responsibilities, pity if this would
                  be changed again. Ergo industry and MDEG disagree.

               Tissue engineering WG – progress reports
                Didier Bouis, CEC: March 2004 target for Council presentation in March / April 2004. 113
                companies in EU, 54 as core business. Products to come to the market in 2006, e.g. arteries,
                kidneys, livers, small companies, only a few with more than 100 employees, 15-20 the average.
                Bioengineering companies, competing with conventional treatment, but improve life quality;
                reimbursement issues; business model mixture of pharmaceutical and medical industry; high R&D
                cost. No EU regulation. UK, DE, FR, ES priority research funding; ethical issues in procurement
                e.g. embrional stammcells, trained personnel needed.
                Three stamms of regulations: tissue banking directive, medicinal products 2001/83/EC; tissue
                engineering.
                Scope and definition: main characteristics is the regeneration of tissues for replacement of …,
                market authorization, centralized procedure preferred, EMEA will have to adapt and set up
                committee for tissue engineering.
                Potential market: 100 to 300 bio Euro market, similar to MD.
                Manufacturing license.
                SE: why old approach, not new approach? – non convincing answer. January 2004 all actors to be
                invited under Commissioner Likainen. Efficacy is not being used because better performance over
                existing products is too difficult to demonstrate, per AT querry. Most companies are located in the
                US, how can they be inspected in the US or JP? via EMEA to be decided …

               Competent Authority Meeting (Rome, October 23-24)
                Brief report by the chair: various topics, e.g. reducing WGs and Task Forces, GHTF and oncoming
                chair, 12 and 13 Jan 2004, meeting with CAs GHTF SC members …

               Latex
                Document was finalized in 2002 and circulated. To be put on the Commission website: UK in
                support and general silence considered approval. Ms. Howes to assign number because chair does
                not know the indexing of MEDDEV documents.

               Electronic labelling – industry position paper
                Presentation by B.O., EDMA. Scope for devices for professional use only. Reluctance by CAs to
                accept proposal e.g. as MEDDEV. Issue becomes even more pressing with accessing countries in
                May 2004.
                Chair: if information is available on paper in all EU languages upon request electronic instruction
                is acceptable. NL to specify its objections. 14 member states might agree with proposal. DE has
                formal objection per NL. DE is not against but cannot agree to present proposal, needs to be
                evaluated. BE would accept CD-ROM where per definitionem a computer has to be used.
                EUCOMED proposes amendment of the directive to allow CD-ROM, internet, to allow for
                regulatory stability.

                  D.P.: Handling the distribution is more expensive than the device. Wish to change the directives,
                  not all languages required on the device itself. Ask for first solution in electronic way, e.g. with
                  CD-ROM.
                  EDMA: facility security – server quality , certification as state of the art, like homebanking
                  -       external provider needed, e.g.
                  -       file safety via PDF e.g., with relevant safety parameters

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                  -         users require already electronic versions
                  -         only for professional use!

                REACH: (registration, evaluation, authorization of chemicals)
                 The DG Environment plans to draw all existing chemical directives into one. The proposal is the
                 REACH Directive with about 1200 pages. Years before the discussion run between the
                 Commission and chemical industries. The down stream users (the users of the chemicals like
                 IVD’s dental material and others) had in the first draft the same requirements like the producers of
                 the chemicals. With the new draft (Oct. 2003) the requirements decreased somewhat to the safety
                 data sheet (SDS), but are still to high for MD. EDAMA, EUCOMED and FIDE asked the
                 Commission for support to exclude MD from the REACH directive.


                Next meetings MDEG etc. in Brussels

                                        3    December 2003                 MDEG vigilance - tentative
                                        4    December 2003                 EC vigilance workshop
                                        5    December 2003                 EC vigilance workshop - tentative
                                        15   December 2003                 MDEG
                                        16   December 2003                 MDEG
                                        17   December 2003                 MDEG classification




signed                               signed                                present                               signed


M. Wenzel                                                                  Christine Tarrajat                    Michael Tillotson
C.F.Wallroth                         Peter Linders                         Benny Ons

EUROM VI                             COCIR                                 EDMA                                  EUROMCONTACT




signed                               signed                                signed                                present



                                     Philippe Auclair
                                     Roland Gerard
                                     Thierry Chignon
                                     Maurice Wagner
                                     Dr. Philippe Verdonck
Dierk Bellwinkel                     Dario Pirovano                        Hans Jaeckel                          Francoise Slemmer
                                     Jean Iyes Carenz

FIDE                                 EUCOMED                               CENELEC                               EA NB MED




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           0.1              Participants (kommt von M. Wenzel)

Firstname         Name                   Affiliation                                Country           27.10.03               28.10.03
Cornelis          Brekelmans             CEC CD ENTR., Brussels                     CE/NL                  1                      x
Joseph            Putzeys                CEC CD ENTR., Brussels                     CE/BE                  x                      x
                  Lacerda De
Antonio           Queiroz                CEC CD ENTR., Brussels                     CE/PT                  x                      x
                                         (CEC CD ENTR., Brussels)
Karen             Howes                  EDMA since July 2003                       (CE)/UK                x                      x
Hannu             Seitsonen              CEC CD ENTR., Brussels                     CE/FI                  x                      x
Michel            Vitucci                CEC CD ENTR., Brussels                     CE/IT                  x                      x
Markus            Zobrist                Swissmedic, Bern                           CH                     x                      x
Brian             Matthews               Alcon Laboratories                         UK                     x                      x
                                         COCIR / Philips Medical
Peter             Linders                Systems, Best.                             NL                     x                      x
Adrianna          Rademakers             Menta Medical Systems, B.V.                NL                     x                      x
Adolf             Schröder               COCIR c/o ZVEI, Frankfurt                  DE                     x                      x
Günter            Strattner              COCIR c/o ZVEI, Frankfurt                  DE                     x                      x
Dierk             Bellwinkel             FIDE c/o VDDI, Köln          DE                                   x                      x
                                         EUROM VI c/o SPECTARIS,
Marcus            Wenzel                 Köln                         DE                                   x                      x
                                         EUROM VI c/o Dräger Medical,
Carl F.           Wallroth               Lübeck                       DE                                   x                      x
Hilde             Boone                  EMEA London                                UK                     x                      x
Roy               Holland                NIOM Certification, Haslum                 NO                     x                      x
Peter             Ruys                   KEMA Medical, Arnheim                      NL                     x
                                         Ministry of Social Affairs of
Leida             Roos                   Estonia, Tallinn                           EE                     x                      x
Ayhan             Kocak                  Ministry of Health, Ankara                 TR                     x                      x
Isabel            Scuntaro               Swissmedic, Bern                           CH                     x                      x
Rainer            Voelksen               Swissmedic, Bern             CH                                   x                      x
                                         Consulant to CEN, chair GHTF
Maurice           Freeman                SG 1                         UK                                   x                      x
                                         Norw. Dirct. For Health and
Sissel            Dyrnes                 Social Welfare, Olso         NO                                   x                      x
Klaus             Stinshoff              Swissmedic, Bern                           CH                     x                      x
                  Hagerup-               Norw. Dirct. For Health and
Ingeborf          Jenssen                Social Welfare, Olso                       NO                     x                      x
                                         Authority for Medical Devices,
Peter             Bunyitai               Budapest                                   HU                     x                      x
                                         Authority for Medical Devices,
Laszlo            Raduj                  Budapest                                   HU                     x                      x
                                         Ministerio de Sandad y
Carmen            Abad Luna              Consumo, Madrid                            ES                     x                      x
                  Cepeda                 Ministerio de Sandad y
Teresa            Murtado                Consumo, Madrid                            ES                     x                      x
Hans-Kristian Andersen                   Danish Medicines Agency                    DK                     x                      x
Jarkko            Ihalainen              National Agency for Medicines FI                                  x                      x
I.                Soetaert               CENELEC, Brussels              BE                                 x                      x
                                         National Agency for Medicines,
Kirsti            Kotaniemi              Helsinki                       FI                                 x                      x
Ancko             de Fries               Minist. Van VWS, The Hague                 NL                     x                      x
                                         Inspectorate for Health Care,
Jos               Kraus                  The Hague                                  NL                     x                      x
                                         Ministry of Health and Social
Brigitte          Wittorp                Affairs, Stockholm                         SE                     x                      x


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                                         Fed. Min. of Social Security &
Wolfgang          Ecker                  Generations, Vienna                        AT                     x                      x
                                         Sc. Inst. Public Health, CA IVD,
Anne              van Nerom              Brussels                                   BE                     x                      x
                                         State Agency of Medicines,
Sulev             Jaksman                Tartu                                      EE                     x                      x
                                         State Agency of Medicines,
Siim              Aid                    Tartu                                      EE                     x                      x
                                         Norw. Dirct. for Health and
Vibeke            Dalen                  Social Affair, Olso                        NO                     x                      x
                                         Norw. Dirct. for Health and
Tove              Farstad                Social Affair, Olso                        NO                     x                      x
David             Fennera                INFARMED, Lisboa                           PT                     x                      x
Heitor Ribeiro Costa                     INFARMED, Lisboa                           PT                     x                      x
J.P.              Vesuypens              CENELEC, Brussels                          BE                     x                      x
Maria Judith      Neves                  INFARMED, Lisboa                           PT                     x                      x
Hans- Georg Will                         BMGS, Bonn                                 DE                     x                      x
Wilfried          Reischl                BMGS, Bonn                                 DE                     x                      x
Matthias          Neumann                BMGS, Bonn                                 DE                     x                      x
Ekkehard          Stösslein              BfArM, Bonn                                DE                     x                      x
                                         Ministrie for Health of NRW,
Reinhard          Kasper                 Düsseldorf                                 DE                     x                      x
Roger             Grase                  BfArM, Bonn                                DE                     x                      x
Steve             Owen                   MDA, London                                UK                     x                      x
David             Jefferys               MDA, London                                UK                     x                      x
                                         Dept. Of Health & Children,
Wilfrid           Higgins                Dublin                                     IR                     x                      x
Ann               O'Connor               Irish Medicines Board, Dublin              IR                     x                      x
Anthony           Camilleri              Malta Standard Authority, Malta MT                                x                      x
Benny             Ons                    EDMA c/o BD Evenbodegen                    NL                     x                      x
Mustafa           Zuhurat                GAYCI, Ankara                              TK                     x                      x
Sarah             Onians                 CEC, Brussels                              CE/BE                  x                      x
Kimmo             Linnavoori             NAM, Helsinki                              FI                     x                      x
Jean Claude Ghislain                     AFSSAPS                                    FR                     x                      x
            Maontagnier-                 Min. Santé Direction
Catherine   Perissans                    Génératede, Paris                          FR                     x                      x
                                         Ministrie v. Volksgezondheid,
Christine         Duerinck               Brussels                                   BE                     x                      x
                                         Direction de la Santé,
                  Scharll                Luxembourg                                 LX                     x                      x
                                         EC Joint Research Centre
David             Rickerby               (IHCP)                                     IT                     x                      x
Philippe          Verdonck               EUCOMED / Baxter, Brussels                 BE                     x                      x
Glenda            Silvester              EMEA, London                               UK                     x                      x
Roa               Marbellyz              CEC DG ENTR                                CE/ES                  x                      x
Suzan             Eichenstein            CEC DG ENTR                                CE/UK                  x                      x
Marvelise         Ruve (?)               CEC DG ENTR                                CE/?                   x                      x
                                         EUCOMED c/o Guidant,
Philippe          Auclair                Diegum                                     FR                     x                      x
Nicolas           Pallikarakis           University of Patras                       GR                     x                      x
Konstantin        Kladiuras      Representive of Grece to EU                        GR                     x                      x
                                 Nat. Organuzation for
Theodore          Ktenas         Medicines, Athens                                  GR                     x                      x
                  Hoekstraxvan Min. of Health and Wellfare and
Sabina            den Bosch      Sport, The Hague                                   NL                     x                      x
                                 Nat. Agency for Medicines,
Hely              ReinikkaxRailo Helsinki                                           FI                     x                      x

                                                                                                                                                                9
           EUROM VI-COCIR-EUCOMED-EDMA-CENELEC-NB-MED-EUROMCONTACT-FIDE Participant’s Meeting Report
           EU Medical Devices Expert Group Meeting                                                                                         ISM 2003-51
           Brussels / October 27 and 28, 2003                                                                                              Nov 4, 2003
           -------------------------------------------------------------------------------------------------------------------------------------------------------

                                         Medicinal Products Agency,
Lars              Johansson              Uppsala                                    SE                     x                      x
Markus            Sievert                EUCOMED                                    DE                     x                      x
Michael           Tillotson              EUROMCONTACT, Romsey                       UK                     x                      x
Davis             Philipson              FPPD                                       UK                     x                      x
Lennart           Philipsson             Medical Products Agency                    SE                     x                      x
Dario             Pirovano               EUCOMED, Brussels                          IT                     x                      x
Marcello          Pani                   U.O. Pharmaceutica, Pisa                   IT                     x                      x
Christine         Tarrajat               EDMA, Brussels               BE                                   x                      x
                                         UEAPME Health Committee,
David             Smith                  Brussels                     UK                                   x                      x
                                         CENELEC c/o Olympus Optical,
Hans              Jaeckel                Hamburg                      DE                                   x                      x
Thierry           Chignon                EUCOMED                                    FR                     x                      x
                                         (EUCOMED c/o Quintiles
                                         Consulting)/ since July 2003
Mika              Reinikainen            EAAR                                       FI                     x                      x
Anthony           Camilleri              EUCOMED                                    BE                     x                      x
Roland            Gerard                 EUCOMED c/o St. Jude                       BE                     x                      x
Michael           Gropp                  EUCOMED c/o Guidant Corp.                  US                     x                      x
                                         Dept. Of Health, Med. Dev.
Richard           Gutowski               Agency, London                             UK                     x                      x
                  Fernandez-             SANCO DG / European
Eduardo           Zincke                 Commission                                 EC-ES                  x                      x
Jozef             Slany                  MZ SR, Bratislava                          SL                     x                      x
                                         Minsitriy of Health od Czech.
Danuse            Drahotová              Rep. Prague                                CZ                     x                      x
Robin             Linden                 National Agency for Medicines FI                                  x                      x
Margerita         Pepe                   Ministero della Salute                     IT                     x                      x
Ennio             Bellocci               Ministero della Salute                     IT                     x                      x
                                         Ministero Attiva Produttive,
Chiesi            Riccardo               Roma                                       IT                     x                      x
Bernard           Lambert                G-MED                                      FR                     x                      x
Elke              Lehmann                BfArM, Bonn                                DE                     x                      x
Gordon C.         Tuck                   EDMA                                       ?                      x                      x
Jean-Jacques Herremans                   UEAPME, Brussels                           BE                     x                      x
Johannes          Jonkheer               CEC DG SANCO, Luxembourg LX                                       x                      x
Barry             Hatt                   INAMED / EUCOMED                           IR                     x                      x
Philippe          Bauwin                 Ministère de la Santé publique             BE                     x                      x
                                         EUCOMED c/o Dery
Sally             Hunter                 International, Leeds                       UK                     x                      x
                                         EUCOMED c/o Zimmer
Suzan             Burnstead              Swindon                                    UK                     x                      x
Didier            de Buis                CEC DG ENTR                                FR                     x                      x
Hermann           Stamm                  IRC ISPRA                                  DE                     x                      x
                  Cordosa
Isabel            Oliviera               INFARMED, Lisboa                           PT                     x                      x
Günter            Siegemund              BMGS, Bonn                                 DE                     x                      x
Michel            Letort                 AFSSAPS, Denis                             FR                     x                      x
                                         NB-MED, NBRG c/o VdTÜV,
Bodo              Mestmacher             Essen                                      DE                     x                      x
                                         Dir. For Health and Social
Bjorn Kristian Berge                     Affairs, Oslo                              NO                     x                      x
A. Fihri          Bakir                  SKYPRO, Brüssel                            TK                     x                      x
                                         EUCOMED c/o Guidant,
Gildas            Sterrinon              Brüssel                                    BE                     x                      x


                                                                                                                                                              10
           EUROM VI-COCIR-EUCOMED-EDMA-CENELEC-NB-MED-EUROMCONTACT-FIDE Participant’s Meeting Report
           EU Medical Devices Expert Group Meeting                                                                                         ISM 2003-51
           Brussels / October 27 and 28, 2003                                                                                              Nov 4, 2003
           -------------------------------------------------------------------------------------------------------------------------------------------------------

                                         EUCOMED c/o Stryker,
Jean Yves         Carentz                Immevble Delta                             FR                     x                      x
Maurice           Wagner                 EUCOMED, Brussels                          BE                     x                      x
Linda             Worley                 Malta Standard Authority, Malta MT                                x                      x
                                         National Agency for Medicines,
Kirsti            Kotanniemi             Helsinki, NAM                      FI                             x                      x
                                         Scientific Inst. Publ. Healt-Louis
Jean-Claude Libeer                       Pasteur/iph.fgov                   BE                             -                      -
Winfried          Mientus                BfArM, Bonn                                DE                     -                      -
Katrin            Westphal               BMGS, Bonn                                 DE                     x                      x
Michael           Cox                    Danish Medicines Agency                    DK                     x                      x
                  Montagnier-            Ministre Sante-Direction
Cathrine          Petrissans             Generale Sante                             FR                     x                      x
Alain             Prat                   Afssaps                                    FR                     x                      x
Helge             Bornhof                PEI                                        DE                     x                      x
                                         Authority for Medical Devices,
Enikö             Halaghy                Budapest                                   HU                     x                      x
Andreas           Schlegel               Swissmedic, Bern                           CH                     x                      x
Birgitte          Andersen               EFTA                                       NO                     x                      x
Christofides      Stelios                Ministry of Cypros                                                x                      x
                                         State Health Care Accreditation
Angele            Kazlauskiene           Agency                          LT                                x                      x
Ludger            Möller                 EAAR, Hannover                             DE                     x                      x
                                         Europ. Ass. Of NB for MD,
Francoise         Schlemmer              Brussels                                   BE                     x                      x
Desmond           Kenny                  CEN Delegation                             IRL                    x                      x
Brice             Paul          MHRA, London                                        UK                     x                      x
                                Ministry of Health, Welfare &
Miranda           Alphenaar-Ras Sports, The Hauge                                   NL                     x                      x
Mr.               Cavallo                                                           CE/PT                  x                      x



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