Home › Blog

PIP - Articles about PIP on the EmergoGroup.com Blog

Europe
November 30, 2012
by Stewart Eisenhart
European Commission Plans Greater Oversight of Notified Bodies
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.
Read full post
Europe
June 27, 2012
by Stewart Eisenhart
EU PIP Scandal - Will PMA System Be The Result?
As we recently reported, the effects of the recent PIP scandal continue to ripple across the European Union.
Read full post
Europe
May 17, 2012
by Stewart Eisenhart
UK Medical Device Regulatory Improvements Urged Following PiP Scandal
A UK Department of Health review of how British regulators managed PiP defective b
Read full post
Europe
May 14, 2012
by Stewart Eisenhart
Regulatory Updates for Europe: OJEC, Borderline Products, and PIP Scandal
Standards in OJEC The Official Journal of the European Union (OJEC) recently published updated lists of harmonized standards relating to the Directives on
Read full post
Brazil
March 29, 2012
by Stewart Eisenhart
ANVISA Gets Strict on Breast Implant Sales in Brazil
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
Read full post
Europe
February 13, 2012
by Stewart Eisenhart
Tighter EU Regulatory Controls Proposed following PIP Controversy
European Union member states should take immediate steps to
Read full post