PIP - Articles about PIP on the EmergoGroup.com Blog

by Stewart Eisenhart
October 23, 2013
The European Parliament has voted in favor of implementing stricter requirements for Notified Bodies, but not for recommended medical device registration reforms that would create an approval process similar to Premarket Approval in the US.
by Stewart Eisenhart
November 30, 2012
The European Commission has drafted additional reforms (“PIP Action Plan”) aimed specifically at greater control of Notified Bodies. These changes are expected much sooner than the impending legislative revisions. The Commission documents are expected to be released before the end of 2012 and the changes will likely be implemented as soon as 2013.
by Stewart Eisenhart
June 27, 2012
As we recently reported, the effects of the recent PIP scandal continue to ripple across the European Union.
by Stewart Eisenhart
May 17, 2012
A UK Department of Health review of how British regulators managed PiP defective b
by Stewart Eisenhart
May 14, 2012
Standards in OJEC The Official Journal of the European Union (OJEC) recently published updated lists of harmonized standards relating to the Directives on
by Stewart Eisenhart
March 29, 2012
Brazilian medical device market regulatory ANVISA has announced tighter controls over sales of breast implants in the country following revelations of defective implants manufactured by French firm
by Stewart Eisenhart
February 13, 2012
European Union member states should take immediate steps to