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									EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------

Participants                                                                                      NBM/002/05
                                                          0                        0
54 delegates and observers from AT, BE, CH, CZ, DE, DK, ES , FI, FR, HU, IT, IR, LT , LX, NL, NO, PT, SE,
SL, UK, CEN, CENELEC0, EDMA, EUCOMED, COCIR, FIDE, EUROMCONTACT, 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, FIDE

COCIR members via
Mr. G. Strattner, COCIR

EMIG members via
Mr. G. Strattner

ZVEI members via
Ms. M. Vedder, ZVEI

EDMA members via
Ms. K. Howes, EDMA

EUCOMED members via
Dott. D. Pirovano, EUCOMED

NB-MED members via
Ms Dr. B. Schmitz, VdTÜV

GHTF SG2 members via
Dr. J. Garcia, TGA
__________________________________________________________________________________________
Address
Tulip Inn Brussels Boulevard Hotel
Avenue de Boulevard 17
B-1230 Brussels
Tel. +32-2-205-1522
Fax +32-2-205-1525
__________________________________________________________________________________________
Place / Date
Brussels / 30 Nov. and 1. Dec. 2004
__________________________________________________________________________________________
Subject
CEC NB-MED Notified Bodies Medical Devices 31st Meeting
__________________________________________________________________________________________

Chair:                             Mr. Bernard Lambert, G-MED
Vice-Chairman:                     pending
Technical Secretary:               Dr. Hermann Dinkler, VdTÜV
Participants:                      54 delegates and observers from AT, BE, CH, CZ, DE, DK, ES 0, FI, FR, HU, IT, IR,
                                   LT0, LX, NL, NO, PT, SE, SL, UK, CEN, CENELEC0, EDMA, EUCOMED,
                                   COCIR, FIDE, EUROMCONTACT, EUROM VI
Place/Date:                        Brussels / 30 November and 1 December 2004



                                                                                                                                                     1
EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------


Executive Summary

The Medical Devices Notified Bodies NB-MED group met for the 31st time 30 November and 1 December 2004
and generated the following conclusions and results:

    Revision of NB-MED recommendation 2.12 Rec.1 Post Market Surveillance
     GHTF SG2 results to be awaited for. NB-MED recommendation to remain as is, MSOG to look into it.

    Transfer of annex II.4 certificate
     NBRG prepared first draft on 29 November 2004 meeting, based on a first draft by G.B. Comments by NB-
     MED members including industry federations by February 2005.

    NBOG liaison
     About a dozen of stage 3 NB-MED recommendations are considered of interest for NBOG to be blessed to
     become MEDDEV documents when blessed by NB-MED. John Worroll in liaising with Steve Owen,
     NBOG chair who is drafting NBOG members for specific reviews.

    Drug-device combination
     Anecdotal evidence of circular consultations between MD CA and drug CA in case of dispute between
     manufacturer / NB and CA without conclusions.

    CIRCA presentation
     NB-MED documentation and registration are exclusively via CIRCA.

    E-labelling
     MDD deletes ‘leaflet’ and has provision for ‘other means’. EC set up WG. There are pilot projects in some
     member states. Deletion of ‘leaflet’ is not final. E-labelling is a very broad term. MDD only addresses
     instruction for use.

    Hard-wire issue
     IEC 60601-1 amendment 2 subclause 56.3 c - Maarten Roelofs Heyrmans letter was resubmitted by
     EUCOMED but apparently not received yet, to be circulated for comments on the proposed exception (for
     hard wired defibrillators).

    Multiple NB numbering of BTTE equipment
     Letter was drafted by the chair to the Commission, response pending. Awaiting internal legal review. Blue
     guide allows several NB numbers on the CE mark if applicable for several directives.
     e.g. 93/42/EEC MDD, 90/385/EEC AIMD and 99/5/EC RTTE.

    Status of sterilization indicators - NBM 090/04 enquiry 69
     Some manufacturers consider them under the MDD while others do not. Sterilization indicators may be used
     for demonstrating the sterile state of medical device; could be considered an accessory of a MD with a
     measuring function. MDEG did not concur except for DE or FR. M.F. ten years ago considered an accessory
     to a MD, i.e. a sterilizer; issue got raised again five years ago with Mr. Putzeys present.

     EUROM VI supported the view that sterilizers are MDs class IIa, see MEDDEV 2.1 citing sterilizers if
     intended for medical use.
     Indicators not to be a MD, straw vote: more than 30 NB, but does not help a manufacturer in FR.
     Issue to be raised at the next meeting.

    Medical gas supply units
     SE manufacturer classified supply units as class I based on a recommendation of SE NB; contradicts
     consensus statement 06/99. Moral obligation to stick to the consensus. C.F.W. and C.J.: active devices are
     involved, e.g. terminal units, ergo rule 9 and 11 applies, consensus statement should stay.
     SEMKO was asked by SE CA for opinion and responded with class I not recognizing any active MD
     component. C.F.W. offered visit to Stockholm to meet with CA and NB using Ryanair direct flight from
     Lübeck to Stockholm-S.Skavsta, e.g. 16 or 17 Dec. 2004.



                                                                                                                                                     2
EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------

    European NB association TEAM-NB
     25 NBs are members (of more than 70), one from a new country, i.e. CZ. Group will meet after the first day
     NB-MED meeting.

    Requirements for technical documentation to be kept available for CA
     Draft proposal by the chair. Obligations of the directive on the own brand labeller as in NB
     recommendation.

    Audit duration determination
     IAF recommendation exists. GHTF cancelled topic at Ottawa 2000 meeting because of lack of consensus
     between industry and regulators. Topic could be discussed within TEAM NB and between NBs and NBOG.
     Benefits should be identified before topic is brought back to this group. Dr. Egid Hilz might be brought back
     to the debate.

    Own brand labelling
     might help the relationship with CA; comments by February 2005.

    Bankruptcy manufacturers
     debated while industry participants were running for the European parliament to observe the 25 th
     anniversary of EUCOMED.

    Medical Device Directives
     Sometime in the future MDD and AIMDD will be combined, but not at this stage.
     MDD: design dossier review - MDOG is developing some text on what is already obvious; safeguard clause
     being reviewed; borderline issues; definitions including authorized representative, ‘importer’ deleted; lay
     users; administrative issues e.g. for funding MSOG, MBOG, GHTF; EMEA; article 14b - CA concern;
     custom made devices excluded from EUDAMED.

     Guidance: distributor, expiration date and stability data for sterile products, definition on disease, risk
     consideration for lay users, GLP.
     Future timetable: impact assessment, new task, almost complete; final proposal for potential approval:
     December 2004.

     Inter-service consultation, TBT and translation.
     Proposal to Council and Parliament - spring 2005.
     Spring in IE lasts from February to May - john.brennan@cec.eu.int Tel. +32-2-298-5024.
     Original directive number will be maintained.
     Next consolidated MDD text for 15 and 16 December 2004 or 12 January 2005 MDEG meeting.

    Directive electric / electronic waste
     Exemption of certain medical devices from ROZ directive is being reviewed, study might be launched in
     spring 2005, not yet out for tender. Enquiry by DG Environment, exemptions need proper justification and
     time frame for compliance.

    WG on vigilance
     MEDDEV 2.12/1 is being reviewed, role of the NB, presentation by H.R. manufacturer to report incidents
     and recalls to NB in case they are related to the certification granted.
     Manufacturers do not comply, no systematic data access; NBOG is developing guidance to NB in parallel.

     NB should verify existence and abeyance of vigilance procedures. NBs have been charging for receiving
     vigilance reports from manufacturers. H.R. would like to have systematic access to all vigilance data and
     postulated that this should be free of charge for manufacturer.
     How much is in line with GHTF guidance? - does not know.
     Comments to hr@mdc-ce.de by 5 January 2005 on H.R. presentation.

    DG ENTR reorganisation
     New structure to be announced 21 December 2004. DG ENTR will be spirit. MD will presumably combined
     with consumer products, automotive, pharmaceuticals ….
     C. Brekelmans’ reassignment is based on 5 year rotation of units heads.


                                                                                                                                                     3
EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------

    Software working group of European Commission
     Chair Prof. N. Pallikarakis had to resign. Standalone software can be regarded as medical device with the
     change of the medical device definition at the October 2004 MDEG meeting.

    Working group of BSE/TSE
     Discussion about transition period; cut off date for products on the market is apparently on the 13 December
     2004. Draft MEDDEG on the web, probably the better version of interpretation of the BSE/TSE directive.

    Notified Bodies Operations Group NBOG
     Letter to NBOG draft by J.W.: handling by NB of own brand labelling and transfer of certificate
     coordination between vigilance WG and NBOG. D.P. encouraged J.W. to provide written report from the
     NBOG meeting.

    Market Surveillance Operation Group
     Mostly confidential issues are discussed, CA will contact NB directly.

    EUDAMED
     GMDN needs translation into 20 European languages, copyright with CEN, GMDN is a living document
     managed by maintenance agency, what is the status of such agency, is it legal to give regulatory tasks to
     such agency - pending questions. Certificate information is fed into DIMDI in DE, transfer semi-automated.
     M.F.: some progress on legal issues, AU is putting GMDN into its regulation, FDA is transferring towards
     GMDN, JA has translated into JA.
     Commission decision needed.

    Global Harmonization Task Force - GHTF
     SG1 - regulatory systems, M.F.: last meeting in October (in Lisbon) classification document is mostly
     completed, will not be published until conformity assessment guidance is complete.
     STED guidance on length and depth: JA is hovering towards two groups MD definition: comments come
     from trade organization represented at SG1. IVD risk based classification rules guidance evolving.

     SG4 - auditing, J.R.: last meeting in November in Canberra, auditing strategy guidance completed, auditing
     risk management still pending joint SG3 - SG4 meeting planned in spring 2005.
     J.B.: STED usefulness, FDA pilot process with limited feedback, European feedback embarrassing, because
     it is not known, NB information feedback requested on STED use; same is true for AU; JA is building
     STED into JA regulation. On next NB-MED agenda. How does STED relate to NB recommendation on
     technical documentation, part 1 or part 2 or both? Is now with NBOG.

    GHTF SG5 clinical evaluation
     Mr. Schuber, G. Boss substitute as NB representatives to follow.

    Mutual Recognition Agreement MRA
     J.B.: MRAs they are not working well.
     US: send e-mail to J.B.
     AU: updated joint implementation plan with NBOG, article 233 Committee review next, NBs on the list do
     not need reconfirmed.

     Taiwan: NB-MED plans to staff training of Taiwan auditors in Brussels.
     CN: meeting last week in Brussels on pressure vessels, not MD; C. Brekelmans Chair, Michael Gropp
     presenter. Such meetings take place twice a year, next time in China, half day on MDs.

    Standardization
     M.F. had just left. European Journal to publish all particular and collateral standards in support of the
     medical directives.

    European Co-operation of accreditation EA
     Some feedback via the chair from R.H. who had already left.

    New mandated
     On mattresses, to be signed in a week, to see a resolution of the (flammability) problems.


                                                                                                                                                     4
EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------

    Problems with harmonized standards
     EN 980:2003 appears to allow to use logo instead of full name and address. J.R. had complained in writing
     some 5 years ago to the Commission.
     EMIG had also intervened some time ago. Documents to be recirculated.

    ISO 13485:2003 quality systems and ISO 14971:2000 risk management
     Non-conformity to be considered major non-compliance to lead to loss of certificate, ISO 13485:2003
     requires risk management but ISO 14971 is only a recommendation. Compliance with EN 1441 risk analysis
     might be sufficient for low risk devices.

    Standard to be de-harmonized
     Dr. Peter Ruys, former NB-MED KEMA member, asked via e-mail why EN 46003 is harmonized under the
     AIMDD, no reason found, might lead to de-harmonization.

    ISO 9001:200 certificates
     Module H compliance without design control confusion. Commission is asking for experience with
     modules, e.g. H +.

    IVD matters
     Left for small group to consider.

    Next meetings
     5 and 6 April 2005                        Brussels
     29 and 30 November 2005                   Brussels



signed                                         present                                        present

                                               Dr. Philippe Verdonck
Dr. Carl F. Wallroth                           Dott. Dario Pirovano                           Jesus Rueda Rodriguez
EUROM VI                                       EUCOMED                                        EDMA


signed                                         present                                        signed

Michael Tillotson                              Meike Vedder                                   Dott.ssa Linda Sanin
Anne-Marie Wolters
EUROMCONTACT                                   COCIR                                          FIDE




                                                                                                                                                     5
EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------

0.1        Participants

Name                                           Affiliation                              Country                                   30 Nov./1 Dec.
Hannu Seitsonen                                DG Enterprise                              FI                                             -
John Brennan                                   DG Enterprise                              UK                                             x
Dr. Antonio Lacerda                            DG Enterprise                              PT                                             -
Bodo Mestmacher                                RWTÜV Systems GmbH                         DE                                             -
Dr. Hermann Dinkler                            VdTÜV                                      DE                                             x
Dr. Birte Schmitz                              VdTÜV                                      DE                                             x
Pascale Terranova                              ECTA                                       IT                                             x
Michael Pötzleitner                            TÜV Österreich                             AT                                             x
Dr. Norbert Leitgeb                            PMG Austria                                AT                                             -
Rudy Dequirez                                  APRAGAZ                                    BE                                             x
Kaarle Kylmälä                                 VTT Industrial Systems                     FI                                             x
Bernard Lambert                                G-MED                                      FR                                             x
Johann Rader                                   TÜV Product Service                        DE                                             x
Claus-Uwe Hinrichs                             LGA                                        DE                                             x
Kuno Münch                                     LGA                                        DE                                             -
Dr. Gero Viola                                 TÜV Rheinland Product Safety GmbH          DE                                             x
Hans-Peter Bonifer                             DQS GmbH                                   DE                                             x
Stefan Hofmann                                 VDE Testing and Certification Institute    DE                                             x
Harald Renschler                               mdc medical device certification GmbH      DE                                             x
Vilmos Darday                                  ORKI-Inst.for Medical and Hospital Eng. HU                                                -
Zoltan Czaganyi                                ORKI-Inst.for Medical and Hospital Eng. HU                                                x
Deirdre Ni Bhroin                              NSAI                                       IR                                             x
Dr. Paolo Gianoglio                            IMQ S.p.A.                                 IT                                             -
Maurizio Bianchi                               IMQ S.p.A.                                 IT                                             -
Dr. Daniele Zerbi                              Istituto di Ricerche e Collaudi M.Masini   IT                                             -
Dr. Vincenzo Barbaro                           ISS-Istituto Superiore di Sanita           IT                                             -
Dr. Massimo Neroni                             ISS-Istituto Superiore di Sanita           IT                                             -
Claudio Raponi                                 CERMET SCRL                                IT                                             -
Laurent Linden                                 SNCH                                       LX                                             -
Eugenie W. Husebye                             Det Norske Veritas                         NO                                             x
Dr. Roy Holland                                NIOM Certification                         NO                                             x
Isabel Oliveira                                INFARMED                                   PT                                             x
Dr. Rok Hrovatin                               SIQ-Slovenian Institute of Qual.&Metrol. SL                                               x
Maria Jesus Cantalapiedra                      AEMPS                                      ES                                             -
Karl-Gustav Strid                              SV.Provnings- & Forskningsinstitut         SE                                             x
Nils Bromander                                 Intertek SEMKO AB                          SE                                             x
Dr. Karin Schulze                              SQS-Swiss Assoc.f. Quality Managem.Sys. CH                                                x
René G.M. van Melick                           TNO Certification Medical                  NL                                             -
Gert Bos                                       KEMA Quality B.V.                          NL                                             x
John Howlett                                   BSI                                        UK                                             x
John Worroll                                   BSI                                        UK                                             x
Sharon Williams                                LRQA-Lloyd’s Register Quality Assur.       UK                                             -
Christopher Jepson                             SGS United Kingdom Ltd.                    UK                                             x
Geoffrey Hines                                 Intertek Testing and Certification         UK                                             x
Henry Marshall                                 UL International (UK) Ltd.                 UK                                             x
Václav Kahánek                                 Institute for Testing and Certification    CZ                                             x
Ota Stastny                                    EZU (Electrotechnical Testing Inst.)       CZ                                             x
Stasys Kaseta                                  SERTIKA                                    LT                                             -
Philippe Bauwin                                SPF Santé Publique                         BE                                             x
Teresa Cepeda                                  Agencia Española de Medicamentos           ES                                             -
Dr. Stephan Mieke                              PTB                                        DE                                             -
Dierk Bellwinkel                               FIDE                                       DE                                             -
Dott.ssa Linda Sanin                           FIDE                                       IT                                             x
Francoise Schlemmer                            EA NB-MED                                  FR                                             x
Dott. Dario Pirovano                           EUCOMED                                    IT                                             x
Philippe Verdonck                              EUCOMED                                    BE                                             x
Ditte Norgaard-Andersen                        EUCOMED                                    DK                                             -

                                                                                                                                                     6
EUROM VI-COCIR-EUCOMED-EDMA-FIDE-EUROMCONTACT Participants’ Meeting Report                                                                  dr.cfw-mö
CEC NB-MED Notified Bodies Medical Devices 31st Meeting                                                                               ISM 2004-61
Brussels / 30 November and 1 December 2004                                                                                      11 December 2004
-------------------------------------------------------------------------------------------------------------------------------------------------------

Richard de Grood            COCIR                               NL                   -
Meike Vedder                ZVEI and COCIR                      DE                   x
Karen Howes                 EDMA                                UK                   x
Michael Tillotson           EUROMCONTACT                        UK                   x
Dr. Carl F. Wallroth        EUROM VI                            DE                   x
Jennifer Laurent            ECTA                                BE                   x
Isabelle Demade             DG Enterprise                                            x
Ronan Maquestiau            CEBEC                               BE                   x
Carsten Worm                DGM                                 DK                   x
Jens Grothues               TÜV Nord Cert.                      DE                   x
Dr. Thomas Feldman          RWTÜV Systems GmbH                  DE                   x
Jürgen Botzler              DEKRA-ITS Certif.Servives           DE                   x
Klaus-Dieter Ziel           MEDCERT GmbH                        DE                   x
Istvan Seres                MEEI                                HU                   -
Frank Skarpsno              NEMKO AS                            NO                   x
Frantisek Suba              VUTCH-CHEMITEX                      SL                   x
Matej Pollak                VUTCH-CHEMITEX                      SL                   -
Peter Korbel                EVPU                                SL                   -
Marie Olsson                INTERTEK SEMKO AB                   SE                   x
Ronald Nash                 AMTAC Cert.Servives                 UK                   x
Maurice Freeman             CEN Observer                        UK                   x
Anne-Marie Wolters          EUROMCONTACT                                             x
__________________________________________________________________________________________
total                                                                                54




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