The European marketing approval system for medical devices is less stringent than other regions of the world and because of that, at times it is viewed as a more attractive market for device manufacturers. However over the past few months, a new proposal has come up in Europe that could drastically change the approval process.

Currently in Europe, medical devices of all classes are approved by self-proclamation of conformity to specific safety standards. This conformity is verified and authorized by qualified notified bodies.

The proposal from EU Parliament suggests a new type of marketing authorization procedure which requires pre-market approval for class III devices as well as implantables, combination products and cell-based medical devices. Medical devices in the EU classified as class I, IIa and IIb would be subjected to the old approval process (conformity assessment).

This more stringent approach for the higher risk devices has many potential impacts on the industry and the manufacturers as well as on those governing bodies. It begs the question as to what length the EU is willing to go in order to ensure an increase in patient safety, and if this new proposal will provide the means to do so.

RAPS has been following this topic since the release of the draft report in April 2013. Continue reading their articles to learn more about the issue and the impact it can have.

RAPS1, RAPS2, RAPS3

-Jillian F. Walker

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