EMA Takes Over Permanent Secretariat For Medical Device And IVD Expert Panels
Despite resistance from the medtech industry, the European Medicines Agency now has a key role in the medical device and IVD expert panels, which have only recently been set up.
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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.
Is it time to reflect on how the EU can take measures to escape a situation where regulation threatens innovation, product availability and product costs and to stop this trajectory of ever increasing the regulatory bar?
The task force, which is a key component of the European Medicines Agency’s extended mandate, will include experts in the fields of vaccinology, antivirals, clinical trials, immunology and immunotherapy.