Expert Panels To Offer Some Device Manufacturers Scientific Advice Under EU Pilot

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.

The pilot project, which is set to launch in February, will enable manufacturers of certain high-risk devices to receive advice on clinical development strategies from EU expert panels in the context of the Medical Device Regulation.

High-risk devices that fall into class III or are class IIb devices that are designed to administer or remove medicinal...

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