EC Issues Rules on Standards, Audit Requirements for Notified Bodies

October 8, 2013
The European Commission moved to strengthen oversight and qualifications of notified bodies, adopting two rules one day ahead of a pivotal committee vote in Parliament on controversial changes in medical device and in vitro diagnostic devices regulations. The measures, adopted Sept. 24, further the goal of a January 2012 joint action plan between the commission and EU member states, following the PIP breast implants scandal: to ensure that called-for reforms of notified bodies go forward in the event the current legislative effort fails.
International Medical Device Regulatory Monitor