Medical Devices and the EU Path

Over the past decade it has become common for some medical device companies to introduce a product to the European market prior to attempting to gain FDA approval and sell the same device in the United States. In some cases, depending on the classification and technology of the device, Europe can provide a quicker route to marketability.

It’s easy to see how the potential of quicker approval and the associated cash infusion offered by European sales is tempting to a large number of medical device companies interested in generating income after a long research and development cycle. However, it would be wrong to think that obtaining an EU CE Mark is in any way a simple procedure, or one which is without its unique challenges. Not all devices will enjoy the same rapid review, and in some cases, obtaining the CE Mark could be as lengthy as obtaining 510(k) approval from the FDA. This is why submitting a device in both Europe and the United States simultaneously is a solid strategy for medical device manufacturers.

Some of the differences between CE Marking and FDA approvals can be associated with the competition between independent commercial notified bodies that can introduce a degree of uncertainty into the approval process, and in some cases result in quicker time to market for a given product. Some high-risk class III devices can also be held to a different standard of safety and performance in the pursuit of the CE mark, which may require less complex – and shorter – clinical trials than in the U.S. Some moderate- and lower-risk devices, class IIa,b, and I respectively, may be able to satisfy the clinical evaluation requirement through a critical evaluation of relevant scientific literature and not require clinical data. It should also be noted that a successful EU clinical trial does not necessarily indicate certain U.S. FDA acceptance of the same EU clinical information.

Industry, government, and lobby groups have been calling for the FDA to streamline the 510(k) process in order to maintain an American lead in medical device innovation. The European model is often pointed to as an example of what the United States should try to achieve, in large part due to the rapidity with which certain products can reach the market. Recent changes to the EU Medical Device Directive have added new complexities to the CE Marking approval process, however, the CE Mark pathway still has the potential for a quicker route to market for certain medical devices, particularly given the potential changes by the FDA to the 510(k) process which could result in a more conservative route to U.S. marketability.

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adapted and republished from Aptiv Solutions Blog

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