Presentation is loading. Please wait.

Presentation is loading. Please wait.

11 The European Association Medical devices Notified Bodies.

Similar presentations


Presentation on theme: "11 The European Association Medical devices Notified Bodies."— Presentation transcript:

1 11 The European Association Medical devices Notified Bodies

2 2 Aims: Communication with –European Commission –Competent Authorities –Industry Promote technical and ethical standards Participate in improving the legal framework Contribute to harmonization Represent Notified Bodies Team-NB-Presentation on Code of Conduct V3-ppt TEAM-NB

3 3 Context of TEAM-NB TEAM-NB representatives logo I M D R F Commission CEN CENELEC EMEA NBRG CPME Health Professionals Team-NB VI, EUROM Contact, Assoc = EUCOMED, FIDES, EDMA, EUROM UEAPME, Eur Assoc of Auth Repr Notified BodiesManufacturers National Accreditation Bodies 27 Competent Authorities M R A - Switzerland - Canada - Australia - New Zealand - USA - Japan, … Authorised Reprentatives NB- MED Notification MDEG NBOGMSOG Experts Groups EUDAMED, IVD, Vigilance Team-NB-Presentation on Code of Conduct V3-ppt

4 Mandatory to sign for TEAM- NB members Available on website Changes and additions: –Extension to IVD –Unannounced visits –Product Verification –Supervisory Structure –Peer assessment 4 Code of Conduct V3 Team-NB-Presentation on Code of Conduct V3-ppt

5 Detailed content CoC V3 Implementation, enforcement and monitoring of the Code of Conduct Qualification and Assignment of Notified Body Assessment Personnel Minimum time for Notified Body assessments Unannounced visits Sampling of class IIa and IIb technical files Design Dossier Reviews Rules for subcontracting Rules for Certification Decisions 5 Team-NB-Presentation on Code of Conduct V3-ppt

6 Quality of Notified Body work Code of Conduct addresses where NBs diverge Detailed requirements with less room to interpret Result must be more consistent Requires consistency in oversight => cross-inspections IndependenceIntegrityCompetence Time spent Quality Interpretation 6 Team-NB-Presentation on Code of Conduct V3-ppt

7 Team-NB main commitments TEAM-NB members are committed to ensure the safety of Medical Devices on the EU market TEAM-NB members abide by regulatory and ethical aspects by law as well as on voluntary basis TEAM-NB members agree to be submitted to a strong and harmonized assessment and surveillance system by member states and commission TEAM-NB members are fully aware of their responsibility to ensure certification of medical devices complies with the Directives 7 Team-NB-Presentation on Code of Conduct V3-ppt

8 8 Contacts Management: Gert Bos – president Hans Heiner Junker – vice president Guy Buijzen – assistant vice-president Aud Løken Eiklid - treasurer Corinne Delorme – secretary Françoise Schlemmer -Director and Secretariat Team-NB-Presentation on Code of Conduct V3-ppt


Download ppt "11 The European Association Medical devices Notified Bodies."

Similar presentations


Ads by Google