European Commission Issues New Medical Device Guidelines
Thursday, September 27, 2012
The European Commission issued proposed measures recently that called
for moving towards a centralized pre-market authorization system
similar to the United States.
The measures are currently being examined, but many stakeholders have
already raised concerns that they would delay patient access to medical
technologies and unnecessarily thwart innovation in Europe.
"The existing regulatory framework has demonstrated its merits but it
has been in place for 20 years and like any regulatory regime dealing
with innovative products, needs revision," according to the Commission's
proposal. "Moreover, it has recently come under harsh criticism in the
media and the political arena."
Special attention was paid to a proposed measure known as "scrutiny
procedure," where a central panel of advisors would monitor the various
assessment agencies that currently oversee medical device control in the
MDMA continues to work with FDA and our partners to address concerns
with regulatory bodies as they examine their processes to ensure they