Incomplete Scope Another factor affecting the viability of the notified bodies’ code of con

Incomplete Scope

Another factor affecting the viability of the notified bodies’ code of conduct is the breadth of the document’s scope—does it adequately cover all major components of notified bodies’ business activities? The more comprehensive the code’s requirements, the more convincing these firms’ intent to self-regulate would seem to outside observers.

But the code of conduct in its current, public version is not complete. This is because, according to Team NB, the association could not muster a majority of members to adopt the document as a requirement for membership.As such, the NB5 opted to sign on to the code and make it public while continuing work on the document for an October 2011 re-release designed (hopefully) to attract more notified body signatories.

If the NB5Plus Group cannot attract more adherents—or at least an NBOG endorsement of its efforts—it is difficult to envision a successful outcome for the code of conduct.

Issues that the next version of the code will need to cover include incorporation of the IVD Directive; defining and setting rules for review of devices using human or animal components; incorporation of conformity assessments described in MDD Annex III or AIMD Annex 3 as well as MDD Annex IV or AIMD Annex 4; discrepancies between different notified body reviews of clinical evaluations under MEDDEV 2.7.1; and rules for own-brand-labeling manufacturers.

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NB5 has two key goals to meet byOctober: adequately addressing the outstanding issues previously mentioned in an improved version of the code of conduct and achieving critical mass in terms of getting enough notified bodies to sign on to the rules in order to make them viable—and convince EU regulators that Team NB as a whole takes self improvement seriously.