FDA—considers medical devices for clearance or approval through a few different
routes ranging from less-stringent 510(k)s
to clinical trial-backed premarket approvals,
Europe’s system gives that responsibility to
private companies known as notified bodies, which are paid by medical device manufacturers to carry out their reviews.
In the past, notified bodies sometimes
would hire subcontractors to carry out the
assessment of devices. The new rules would
require these bodies to have in-house experts to carry out the work. The legislation
also limits the number of notified bodies allowed to handle review of implantable devices, and requires them to be supervised by
the European Medicines Agency, the regulator that oversees pharmaceutical safety.
The new rules would allow for unan-
nounced inspections of device makers, and
would require every patient receiving an im-
plant to be registered in a central database,
so they could be contacted quickly in case of
a problem. During the PIP scandal, officials
had difficulty tracking patients who had re-
ceived the breast implants.
Carl Heneghan, a physician and professor of evidence-based medicine at Oxford
University, called the rules a“step forward”
but criticized officials for leaving the review
process in the hands of private firms that
are paid by the medical device industry. This
allows companies to“shop around” for the
most compliant firm, he said.“If a company
doesn’t get you approved, you’ll go else-where,”he told the Journal.
Europe, he said, should have one central, taxpayer-funded device regulator, like
the FDA. Some members of the European
Parliament also pushed for this but it didn’t
garner enough support.
Officials of the European Confederation
of Medical Device Associations (Eucomed)
welcomed the vote’s outcome. “The parlia-
ment has voted for many improvements
that will effectively improve patient safety,”
said Eucomed CEO Serge Bernasconi. “We
believe that this paves the way for further
needed improvements to be discussed ... We
congratulate the parliament in finding more
clarity and positive approaches in important
areas supporting safety of patients and in-
novation for patients in what has been a
very complex and highly technical dossier.
We are looking forward to seeing contin-
ued evolution on a future strengthened EU
framework for medical devices.”
Eucomed officials noted that, from
their perspective, there was still work to be
done—particularly in the area of medical
device reprocessing. The group argues that
reprocessors aren’t held to the same strict
standards as device companies and that the
proposed legislation needs “clarified” language in the area of reprocessing.
Bard Boosts Third-Quarter
Sales, Hires in N.Y. State
Medical device maker C.R. Bard Inc.