EU

Revised Code of Conduct for Notified Bodies

In European Market, Regulatory by batzenhoefer@namsa.com

Version 3.2, of the Code of Conduct for Notified Bodies was released in July of 2014. The origin of the Code of Conduct for Notified Bodies derives from Directives written by the European Parliament and is adopted by The European Association for Medical Devices of Notified Bodies (Team-NB) to reinforce the requirements for the European CE marking certification of medical devices.

The changes added to this latest version were implemented immediately by the member organization. Some of the changes include:

  • The addition of external experts, such as clinical specialists, for the review of a design dossier;
  • Two partial audits can replace one full audit as long as all necessary chapters of the Directive are acknowledged during both audits and they were determined successful;
  • Increased maintenance for qualification renewals;
  • Additional qualification requirements for product assessor MDD (Medical Device Directive) and IVDD (In Vitro Diagnostic Directive);
  • Unannounced audits focusing on products;
  • The required frequency of unannounced visits for high risk devices was changed;
  • Class I sterile/ Class I measuring devices and IVD self-test devices added under unannounced visit scheme;
  • Normal conditions resume when non-compliance is no longer appropriate for devices; and
  • Affiliated legal entities within a company are viewed as external organizations.

Version 4.0, currently under review by Team NB members, will include more significant guidance and changes in the following areas:

  • Define criteria to review technical knowledge and criteria for training and proofs.
  • Specific need to review of files under sampling regime.
  • Clarify the qualifications of auditors based on Technical areas.
  • Time needed for class I sterile device reviews in annex II.
  • Review minimum time spent on technical file reviews.

Version 4.0 is expected to be released in October and have a 6 month transition period.

Next Steps

Authors:
Barb Atzenhoefer