What is the Code of Conduct for Notified Bodies?
TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization in which the members are Notified Bodies (EU bodies accredited to certify for CE marking). It has recently published the version 3.0 of the code of conduct for Notified Bodies.
The document may be considered by many as a “reply” of Notified Bodies to the recent adoption of the new proposals for medical device regulations, 2012.541 & 2012.542 by the European Commission. These proposals bring forth even stricter criteria for Notified Bodies as opposed to those currently present within the medical device directives, MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
The Code of Conduct presents the following elements (amongst others):
- General principles of conduct
- Implementation and monitoring of the Code of Conduct
- Qualification and Assignment of Notified Body Assessment Personnel
- Assignment of personnel
- Minimum time for Notified Body assessments
- Unannounced inspections
- Sampling of class IIa and IIb technical files
- New clients – Initial review and subsequent audits
- Product line additions
- Re-certification process – State of the art and Technical File Maintenance
- Assumed clients – Initial review and subsequent audits
- Design Dossier Reviews
- Rules for subcontracting
- Rules for Certification Decisions
The aim of the document can be extracted from its title: “Improving implementation of the European CE certification of medical devices through harmonization of quality and competence of Notified Bodies”.
Taking into account that not all Notified Bodies are members of TEAM-NB and that not all members of TEAM-NB itself, have signed the Code of Conduct as of yet – A question mark remains as to the real “value” of this initiative by TEAM-NB.