T he E uropean A ssociation M edical devices - N otified B odies

1. TEAM NB The European Association Medical devices - Notified Bodies

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. List of Team-NB members • 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) *(Identification number - Country)

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

5. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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

6. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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

7. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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,…

8. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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

9. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • CEN CENELEC : • CEN : “Centre Européen de Normalisation” - Integrated system for European standardization to deliver formal standards. • CENELEC : « Centre Européen de Normalisation Electrique »

12. Commission CEN CENELEC NB-MED MDEG EMEA NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance • 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

13. TEAM-NB’s website

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

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. Contacts Management: • President : Chris Jepson at Chris_Jepson@sgs.com • Treasurer : AudLokenEiklidat aud.loken.eiklid@dnv.com • Vice-president : Werner Kexelat Kexel@eurocat.de Secretary: Gero Viola at gero.Viola@de.tuv.com Director and Secretariat: • Françoise Schlemmer at Schlemmer@quasys.com