Expert panels: First opinion on Class III implantable device released

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:

  1. 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 . . .

    Oh! It looks like you do not have access to this page.
    Find the membership plan that suits you, and within a few minutes you are good to go.
    Are you a member already? Log in here.