EC Issues Rules on Standards, Audit Requirements for Notified Bodies

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