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

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

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)

Context of TEAM-NB Commission TEAM-NB representatives CEN CENELEC 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 H T F Health Professionals Notified Bodies Manufacturers Authorised Reprentatives Notification National Accreditation Bodies 27 Competent Authorities TEAM-NB representatives

NB-MED (Notified Bodies Medical Devices) 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

NB-RG (Notified Bodies Recommendation Group) 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

MDEG (Medical Devices Expert Group) 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,…

NBOG (Notified Bodies Operational group) 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

MSOG (Market surveillance Operation Group) 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)

Commission Other groups Stakeholders : Experts EUDAMED Database 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

CENELEC : « Centre Européen de Normalisation Electrique » 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 »

EMEA (European Medicines Agency) Decentralised body in London 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

TEAM-NB’s website 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. 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 ".

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

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

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