1 the european association medical devices - notified bodies

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The European Association Medical devices

-

Notified Bodies

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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 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