Tag Archives: Notified Bodies

EU Medical Devices Regulation Series on Key Issues

It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key … Continue Reading

European Court of Justice To Clarify Device Liability of Notified Bodies

A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence. Last week, a German court referred a liability case involving breast implants to the Court of Justice of the European Union (CJEU) to provide further clarity on the responsibilities and liability scheme for medical devices in … Continue Reading

French Court Finds Notified Body Liable in Breast Implants Scandal

On November 14, 2013, the Toulon Commercial Court found TÜV Rheinland liable towards victims of the PIP (Poly Implant Prothèse) scandal.  The Court concluded that TÜV Rheinland had been negligent in carrying out its duties as a “notified body,” a key element of the European medical devices regulatory framework.  This in turn allowed PIP, a … Continue Reading

Stricter and Clearer Rules for Notified Bodies in the EU

The European Commission has recently adopted new measures as part of the Joint Plan of immediate actions intended to restore patient and professional trust in medical devices and improve their safety, after events like the French breast implant scandal have shaken up the industry. Both initiatives, adopted on 24 September 2013, aim at clarifying and … Continue Reading

“Notified Bodies” Under EU Device Regulations: Under Stricter Control But With More Power

Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure.  For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified Bodies,” are involved. What are Notified … Continue Reading