Manufacturers of high-risk medical devices who would benefit from advice on their intended clinical development strategies for innovative products are being invited to submit a letter of interest to the European Medicines Agency under a pilot scheme. The deadline for applications within the first round is 15 April.

Ten medical device manufacturers will receive scientific advice from expert panels on their product clinical development strategies under a new European Medicines Agency pilot scheme. But who will it ultimately benefit and what does the scheme entail?

Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the ­new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.