EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination
New changes are emerging from the French scandal involving breast implants. 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. Food Court reported on the potential for changes last week which would bring the EC process inline with the US process (click here).
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 told Inpharm 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, known as notified bodies, 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.
InPharm reports the Commission will set out new proposals later this year that are likely to recommend tougher rules on similar medical devices, but it could take up to three years before they are adopted by member states.
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.
Medical device developers should begin to plan their device approval strategies with these changes in mind. Approving a device before the changes may be less burdensome, but will still likely face scrutiny in the post-PIP regulatory climate.
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