A 'chance discovery'

A ‘chance discovery’

HIGH-RISK, Category III,
Surgically implanted
Medical Devices  


A ‘chance discovery’ on 17 March 2010

TÜV Rheinland‘s involvement as a Notified Body ensured that if PIP had manufactured its products according to the reviewed design dossier and quality assurance processes, the implants would have complied with all legal requirements.

Over the years TÜV Rheinland’s experts reviewed more than 10.000 pages of documentation provided by PIP, conducted more than a dozen on site audits to review compliance with the quality assurance system and delivered respective audit reports. Where deviations were found these were diligently followed up. At no time there was an indication of criminal or unlawful behaviour by PIP.

This was also established by the French competent authority Agence nationale de sécurité sanitaire des produits de santé (“AFSSAPS”) in its report dated 1 February 2012. Despite its extensive powers and the findings resulting from the official market surveillance activities, the French authority did not detect any inadmissible variation of the device until it made a chance discovery on 17 March 2010.”