Presentation is loading. Please wait.

Presentation is loading. Please wait.

The European Association Medical devices - Notified Bodies

Published byBrennen Buckingham Modified over 9 years ago

Similar presentations

Presentation on theme: "The European Association Medical devices - Notified Bodies"— Presentation transcript:

1 The European Association Medical devices - Notified Bodies
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 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

5 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

6 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

7 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,…

8 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

9 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)

10 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

11 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 »

12 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

13 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 ".

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 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  Secretary: Gero Viola at gero.Viola@de.tuv.com 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

Download ppt "The European Association Medical devices - Notified Bodies"

Similar presentations

The European Qualifications Framework (EQF)

The European Qualifications Framework (EQF)
Standardization in China

Standardization in China
EPAA Annual conference November 2007 1 Regulatory acceptance of alternative approaches for pharmaceuticals Jean-Marc Vidal Safety & Efficacy of Human Medicines.

EPAA Annual conference November Regulatory acceptance of alternative approaches for pharmaceuticals Jean-Marc Vidal Safety & Efficacy of Human Medicines.
HISPC-Illinois II The Public-Private Partnership Moves Forward on Privacy and Security.

HISPC-Illinois II The Public-Private Partnership Moves Forward on Privacy and Security.
1 NECOBELAC Project WORK PACKAGE 3 Cross-national advocacy infrastructure.

1 NECOBELAC Project WORK PACKAGE 3 Cross-national advocacy infrastructure.
11 The European Association Medical devices Notified Bodies VISION on REVISION.

11 The European Association Medical devices Notified Bodies VISION on REVISION.
The European Association Medical devices - Notified Bodies - www.Team-NB.org Medical Device Survey 2013 data from 28 NBs.

The European Association Medical devices - Notified Bodies - Medical Device Survey 2013 data from 28 NBs.
European COoperation in the Field of Scientific and Technical Research Role and rules of procedure for Management Committee Carine Petit Science Officer.

European COoperation in the Field of Scientific and Technical Research Role and rules of procedure for Management Committee Carine Petit Science Officer.
Medical Devices Regulation in the European Union Albuquerque - 10 April 2012 Emmanuel Grimaud Perfea Innovation Lyon, France – Albuquerque, NM

Medical Devices Regulation in the European Union Albuquerque - 10 April 2012 Emmanuel Grimaud Perfea Innovation Lyon, France – Albuquerque, NM
The European Association of Medical device Notified Bodies

The European Association of Medical device Notified Bodies
The European Association Medical devices

The European Association Medical devices
Special populations- What makes them so special? AGAH Association for Applied Human Pharmacology Annual meeting 2004 Berlin 29. Februar 2004 Birka Lehmann.

Special populations- What makes them so special? AGAH Association for Applied Human Pharmacology Annual meeting 2004 Berlin 29. Februar 2004 Birka Lehmann.
1 The Data Protection Officer at work Experience, good practices and lessons learnt Pierre Vernhes – former DPO at the Council of the EU Workshop on Data.

1 The Data Protection Officer at work Experience, good practices and lessons learnt Pierre Vernhes – former DPO at the Council of the EU Workshop on Data.
RES-H Policy Background and Objectives of the Project 1. Project Meeting Freiburg, 21 October 2008 Veit Bürger

RES-H Policy Background and Objectives of the Project 1. Project Meeting Freiburg, 21 October 2008 Veit Bürger
Center for Clinical Research - Clinical Trials Center (CTC) Clinical Research and Clinical Trials in Switzerland Jürg Lustenberger, PhD Dipl. Pharm. Med.

Center for Clinical Research - Clinical Trials Center (CTC) Clinical Research and Clinical Trials in Switzerland Jürg Lustenberger, PhD Dipl. Pharm. Med.
Modular Urban Transport Safety and Security Analysis 1 SiT - Safety in Transportation 2012.

Modular Urban Transport Safety and Security Analysis 1 SiT - Safety in Transportation 2012.
Standards. A definition A standard is a collection of specifications that has been endorsed by some group so that they may all agree on these issues and.

Standards. A definition A standard is a collection of specifications that has been endorsed by some group so that they may all agree on these issues and.
A Health Professional’s Perspective Dr Michael Wilks CPME www.cpme.eu.

A Health Professional’s Perspective Dr Michael Wilks CPME
UDI and the GMDN (Global Medical Device Nomenclature)

UDI and the GMDN (Global Medical Device Nomenclature)
An introduction to the EU and its legislation. Member States currently 15 –Austria- Ireland –Belgium- Luxembourg –Denmark- Netherlands –Finland- Portugal.

An introduction to the EU and its legislation. Member States currently 15 –Austria- Ireland –Belgium- Luxembourg –Denmark- Netherlands –Finland- Portugal.

Similar presentations

Ads by Google