Regulatory Focus™ > News Articles > UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

Posted 06 January 2012 | By Alexander Gaffney, RAC 

European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals process that would require the sort of marketing authorization currently given to pharmaceutical products, according to Reutersarticles.

"I see an urgent need to regulate devices at the same level of science and attention as with drugs," said Rasi, the new head of EMA.

Currently, medical devices go through a less arduous approvals process than do pharmaceutical products, which need to prove both safety and efficacy to Europe's centralized regulatory body, the EMA.

Medical devices are approved by the decentralized regulatory bodies of each Member State, and only need to show adherence to quality standards and safety before being sold to the public.

The French regulatory authority, AFSSAPS, is currently embroiled in a scandal involving their handling of Poly Implant Prothese's (PIP) silicone breast implant products, which reports say are rupturing at an abnormally high rate and used industrial-grade silicone instead of the medical-grade silicone they were supposed to use.

The head of AFSSAPS, Dominque Maraninchi, mirrored Rasi's and Bertrand's calls, saying, "there was no regulation in place requiring manufacturers to implement proper controls."

Bertrand has called for the devices to receive approval by way of a Marketing Authorization Application-ordinarily reserved for pharmaceutical products-before being granted access to market.  The move could bring Europe's medical device approvals process more in line with the US, which has a risk-based approvals system for medical devices.


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