Manufacturers Can Now Apply For Clinical Advice Under EU Expert Panel Pilot
Five successful applicants will be selected in April, followed by five more in September
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.
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The role of expert panels under the EU’s Medical Device Regulation in adopting opinions for innovative high-risk devices is well established. But manufacturers can benefit now from a second swathe of opportunities as these groups continue to gear up to also provide scientific advice.
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?
Manufacturers of high-risk class III medical devices and class IIb active medical devices that administer or remove medicinal products from the human body will be able to access expert panel advice prior to applying for CE-marking under a newly-announced European Medicines Agency pilot scheme.