EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination

| 17 January 2012 |  By 

The European Commission (EC) will investigate whether or not to recommend regulating higher-risk medical devices such as pacemakers and implants differently than lower-risk medical devices, reports InPharm.

Regulated medical devices in the EU and US are classified according to risk, with Class I devices representing the lowest probable risk, and Class III medical devices representing the highest probable risk.

EC Health and Consumer Policy Spokesperson Frederic Vincent said that the Poly Implant Prothese (PIP) scandal "reinforces our opinion that we have to be tougher on medical devices, particularly class III."

Breast implants sold by PIP have been reportedly rupturing at an abnormally high rate, and further reports have indicated that the company used unapproved industrial grade silicone instead of the approved medical grade silicone.

Currently, medical devices in the European Union 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 European Medicines Agency (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. Once a medical device has received marketing approval, it is the responsibility of each Member State to monitor the safety of the medical device. Vincent noted that new proposals could seek to make new recommendations for Member States to coordinate their activities more closely, as well as new recommendations regarding the use of notified bodies in order to prevent episodes like the PIP scandal from occurring again.

The new proposal would bring the EU's medical device regulations in to closer alignment with the US's Premarket Approval (PMA) system, which regulates medical devices that are determined to be "high risk"-usually Class III medical devices and some Class II devices-with a stricter level of scrutiny than devices cleared by the 510(k) program.

Medical devices cleared by the 510(k) program only need to show that they are "substantially equivalent" to predicate devices in order to be cleared.

It is unclear, however, if the proposed EC recommendations would have done much to stop the PIP scandal. "We are dealing with a case of fraud. It means that what happened in France could have happened even with a more stringent pre-market assessment of the products," said Vincent.

The EC's move toward recommending stricter product regulation mirrors calls made by EMA Executive Director Guido Rasi, UK National Health Service Secretary Andrew Lansley and French Health Minister Xavier Bertrand.


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