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1 The European Association Medical devices - Notified Bodies.

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1 1 The European Association Medical devices - Notified Bodies

2 2 TEAM-NB To improve communications with –the EC Commission, –Industry, –Competent Authorities and –User Groups To promote high technical and ethical standards Members are Notified Bodies under any or all of the 3 medical devices directives: –90/385/EEC –93/42/EEC –98/79/EC

3 BSI (0086 – UK)* CERMET (0476 – I) DGM (0543 – DK) DNV ( 0434 – N) DQS (0297 – D) ECM (0481 – D) EUROCAT (0535 – D) ITC (1023 – CZ) INTERTEK AMTAC CERT (0473 – UK) INTERTEK ETL SEMKO (0359 – UK) INTERTEK SEMKO AB (0413 – S) KEMA (0344 – NL) LNE - G-MED (0459 – F) LRQA (0088 – UK) MDC (0483 – D) MEDCERT (0482 – D) NSAI ( 0050 – IRL) ORKI (1011 – HUN) SGS (0120- UK) SNCH (0499 – L) TÜV AUSTRIA (0408 – A) TÜV NORD CERT( 0044 – D) TÜV Rheinland (0197 – D) TÜV Süd Product Service (0123 – D) UL International (0843 – UK) VTT AUTOMATION (0537-FI) 3 List of Team-NB members * (Identification number - Country)

4 4 Context of TEAM-NB TEAM-NB representatives GGHTFGGHTF Commission CEN CENELEC EMEA NBRG CPME Health Professionals Team-NB VI, EUROM Contact, Assoc = EUCOMED, FIDES, EDMA, EUROM UEAPME, Eur Assoc of Auth Repr Notified BodiesManufacturers National Accreditation Bodies 27 Competent Authorities M R A - Switzerland - Canada - Australia - New Zealand - USA - Japan, … Authorised Reprentatives NB- MED Notification MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance

5 5 Commission CEN CENELEC EMEA NBRG NB- MED  NB-MED (Notified Bodies Medical Devices) Aim : Recommendations to Notified Bodies active in the medical devices field Documents provided: Guidelines, Recommendations and preparation of MEDDEV’s Stakeholders : - Experts - NB’s - Members states representatives - Industry representatives - Commission representatives MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance

6 6 Commission CEN CENELEC EMEA NBRG NB- MED  NB-RG (Notified Bodies Recommendation Group) Aim : Preparing in smaller expert group Recommendations paper Documents provided: Guidelines, Recommendations and preparation of MEDDEV’s Stakeholders : Experts MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance

7 7 Commission CEN CENELEC EMEA NBRG NB- MED  MDEG (Medical Devices Expert Group) Aim : assist the Commission on questions arising from the implementation and practical applications of MDD. Documents provided: MEDDEV’s (almost law) Stakeholders : - Members states representatives - Industry representatives - Standardisation bodies (CEN/CENELEC). - NB’s - Occasionally patients representatives, health care professionals,… MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance

8 8 Commission CEN CENELEC EMEA NBRG NB- MED  NBOG (Notified Bodies Operational group) Aim : to improve the overall performance of the Notified Bodies in the MD sector by identifying and promulgating examples of best practices to be adopted by both Notified Bodies and those organisations responsible for their designation and control. Documents provided: Guidelines Stakeholders : - Members states representatives - NB-Med representative accepted as observer for some subjects MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance

9 9 Commission CEN CENELEC EMEAMDEG NBRGNBOGMSOG Experts Groups EUDAMED, IVD, Vigilance NB- MED  MSOG (Market surveillance Operation Group) Aim : Cooperation between Member States ->carrying out market surveillance. - To increase efficiency of surveillance - To minimise the effect of different surveillance practices - To spread best practices Documents provided: Guidelines Members states representatives (National Competent Authorities)

10 10 Commission CEN CENELEC EMEAMDEG NBRGNBOGMSOG Experts Groups EUDAMED, IVD, Vigilance NB- MED  Other groups  EUDAMED Database Compilation of approved devices --> market surveillance  IVD In Vitro diagnostic technical group, technical and specialist input for other groups  Vigilance Experts Group, improve member states cooperation on vigilance  MDEG-Classification and Borderline issues  CEFT: Clinical Evaluation Task Force Stakeholders : - Experts - NB’s - Members states representatives - Industry representatives - Commission representatives

11 11 Commission CEN CENELEC EMEAMDEG NBRGNBOGMSOG Experts Groups EUDAMED, IVD, Vigilance NB- MED  CEN CENELEC : CEN : “Centre Européen de Normalisation” - Integrated system for European standardization to deliver formal standards. CENELEC : « Centre Européen de Normalisation Electrique »

12 12 Commission CEN CENELEC EMEA NBRG NB- MED  EMEA (European Medicines Agency) Decentralised body in London Protection and promotion of public and animal health - evaluation and supervision of medicines Responsible for scientific evaluation -> approval Pharmacovigilance monitoring MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance

13 13 TEAM-NB stated for The European Association Medical devices - Notified Bodies. We are a non-profit association. Our members are Notified Bodies (see list) under any or all of the three medical device new approach directives: 90/385/EEC; 93/42/EEC; 98/79/EC. list Our aims are : " To improve communications with the EC Commission, Industry, Competent Authorities and User Groups by acting as a focal point and the single voice of Notified Bodies". " To promote high technical and ethical standards in the functioning of Notified Bodies " " To protect the legal and commercial interests of Notified Bodies in their vital role in the functioning of the three medical device directives ". TEAM-NB’s website

14 14 Future developments -Best Practice Guide -Relation with national association -Development of closer contact with European Commission -Development of closer contact with European Parliament representatives -Development of closer contact with industry associations -Web site with availability of MEDDEV & NB-Med Recommendations

15 15 Advantages to protect the legal and commercial interests of Notified Bodies in their vital role in the functioning of the three medical device directives. to join an association which is seen as the authentic and representative voice of Notified Bodies in the field of medical devices

16 16 Contacts Management: President : Chris Jepson at Treasurer : Aud Loken Eiklid at Vice-president : Werner Kexel at  Secretary: Gero Viola at Director and Secretariat: Françoise Schlemmer at


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