What is the role of Expert panels?
According to articles 106 and 48(6) of the Medical Device Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR), the European Commission is required to design expert panels with the aim to:
- Give opinions and views on key documents of the technical files for certain high risk medical devices, i.e., Class III implantable devices and class IIb actives devices which are intended to administer and/or remove a medicinal product and certain in vitro diagnostic medical devices, i . . .
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