TÜV Rheinland is in “complete disagreement” with a ruling by the Paris Court of Appeal that found the German notified body found partly liable in the PIP breast implant case.
TÜV Rheinland Role
TÜV Rheinland is the notified body that had assessed the conformity of the PIP breast implants' design dossier and PIP's quality system against the EU Medical Device Directive. It did not detect the change in material from medical-grade silicone to a non-medically approved gel, when PIP fraudulently used the cheaper filling for some of its implants. Indeed, Medtech Insighthas learned that PIP used medical-grade silicone to conceal its fraud during each of TÜV Rheinland’s on-site audits. Employees at PIP also mentioned medical-grade silicone in the batch documents on a daily basis, even when they used another type of silicone. The producer is also alleged to have hidden barrels of industrial grade silicone that it was using in instead of medical grade silicone, behind its offices when the notified body visited.
The timing is unfortunate as it pits one of the medtech sector’s notified bodies against a high court just when...
