Tag Archives: France

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … 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