May 20, 2011

Notified Bodies BSI, TÜV Rheinland, TÜV SÜD, LNE-GMED and DEKRA/KEMA have made public a code of conduct they drafted earlier this year in accordance with Directives 90/385/EEC and 93/42/EEC.

Although a majority of the Association of Notified Bodies members endorsed the Code of Conduct for Notified Bodies, the document did not garner enough support to become a condition of membership in the association. The Code was developed in response to concerns regarding notified body competency among EU regulators, governments and industry trade groups, according to BSI.

Although the Code was just published in recent weeks, the five notified bodies (the NB5) authoring the document plan to begin work on an “improved” version for release in October, with the goal of maximizing the adoption rate of the Code among European notified bodies.

In the current Code, the NB5 reaffirm their accountability to Competent Authorities, and their obligations to comply with all international standards, laws and regulations of member states.

The NB5 also identified various issues left out of the latest version of the Code, which they acknowledge renders the document incomplete in terms of covering all Notified Body activities. Issues to be addressed in the next version of the code include incorporating the IVD Directive, defining requirements for reviews of devices using animal or human materials, and addressing the Conformity Assessments laid out in MDD Annex III and AIMD Annex 3 (Type Examination), and also MDD Annex IV and AIMD Annex 4 (Batch Certification).

The extent to which those issues are addressed in the next iteration of the Code will no doubt help determine how influential this effort by the NB5 ultimately proves.


  • Stewart Eisenhart