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1
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
• 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)
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List of Team-NB members
*(Identification number - Country)
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Context of TEAM-NB
TEAM-NB representatives
G
GHTF
Commission
CEN CENELEC
EMEA
NBRG
CPME
Health Professionals
Team-NB
VI, EUROM Contact,Assoc = EUCOMED,
FIDES, EDMA, EUROMUEAPME, Eur Assoc of
Auth Repr
Notified Bodies Manufacturers
National Accreditation
Bodies
27 Competent Authorities
MRA
- Switzerland- Canada- Australia- New Zealand- USA- Japan, …
Authorised Reprentatives
NB-MED
Notification
MDEG
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
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Commission
CEN CENELEC
EMEA
NBRG
NB-MED
NB-MED (Notified Bodies Medical Devices)
Aim : Recommendations to Notified Bodies active in the medical devices fieldDocuments provided: Guidelines, Recommendations and preparation of MEDDEV’s Stakeholders :- Experts- NB’s- Members states representatives- Industry representatives- Commission representatives
MDEG
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
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Commission
CEN CENELEC
EMEA
NBRG
NB-MED
NB-RG (Notified Bodies Recommendation Group)
Aim : Preparing in smaller expert group Recommendations paperDocuments provided: Guidelines, Recommendations and preparation of MEDDEV’s Stakeholders : Experts
MDEG
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
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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
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
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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: GuidelinesStakeholders :- Members states representatives- NB-Med representative accepted as observer for some subjects
MDEG
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
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Commission
CEN CENELEC
EMEAMDEG
NBRG NBOG MSOGExperts 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 practicesDocuments provided: GuidelinesMembers states representatives (National Competent Authorities)
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Commission
CEN CENELEC
EMEAMDEG
NBRG NBOG MSOGExperts 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 issuesCEFT: Clinical Evaluation Task Force
Stakeholders :- Experts- NB’s- Members states representatives- Industry representatives- Commission representatives
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Commission
CEN CENELEC
EMEAMDEG
NBRG NBOG MSOGExperts 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 »
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Commission
CEN CENELEC
EMEA
NBRG
NB-MED
EMEA (European Medicines Agency)
Decentralised body in LondonProtection and promotion of public and animal health - evaluation and supervision of medicines Responsible for scientific evaluation -> approvalPharmacovigilance monitoring
MDEG
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
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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 ".
TEAM-NB’s website
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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
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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
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Contacts Management:• President : Chris Jepson at [email protected]• Treasurer : Aud Loken Eiklid at
[email protected]• Vice-president : Werner Kexel at [email protected]
Secretary: Gero Viola at [email protected]
Director and Secretariat:• Françoise Schlemmer at [email protected]