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a set of peer review criteria and a harmonized reporting structure to improve
communications between designated authorities. Clearly despite the NB5Plus
Group's new code of conduct, NBOG is
pursuing its own ideas for how to improve notified body performance.
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 be-
cause, according to Team NB, the associa-
tion could not muster a majority of
members to adopt the document as a re-
quirement 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-re-
lease designed (hopefully) to attract more
notified body signatories.
NB5 has two key goals to meet by
October: 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.
One strategy to consider for New Year’s
resolutions in 2012: Issue them a half-year
later, in the summer of 2012. ;
Stewart Eisenhart is regulatory editor and
Evangeline Loh, Ph.D., RAC, is vice president
of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and
distribution consulting services. Evangeline can
be reached at evangeline@emergogroup.com.
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