GMP for Medical Devices - Lessons learnt from the PIP Scandal?

The scandal of falsified breast implants is making waves. The EU Commission has asked its "scientific committee on emerging and newly-identified health risks (SCENIHR)" for a scientific opinion about the risks for the safety of these breast implants. The results should be available shortly.

Already last year, a member of the "Committee on the Safety of Devices" from the British Medicines and Health Care products Regulatory Authority (MHRA) had criticised the European regulations for medical devices. In the minutes of a meeting there is a part entitled "The Current Regulatory System: Fit for Purpose?" in which he concludes that the system is indeed fit but only when the requirements are met and not treated as "paperwork" to get the CE marking.

Steve Owen, Devices Policy Director at the MHRA, expects proposals for revisions of the medical devices regulations to be published at the beginning of 2012. According to him, the implementation would take place in 2016. His points of criticism - from Great Britain's view - have been recorded in the above mentioned minutes.

Compiled by
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

PS: The EU has published the MEDDEV document 2.1/6 on medical devices with a decision diagram regarding the qualification of stand alone software as medical device or in vitro diagnostic.