What evidence the EU requires for medical devices
How Regulation (EU) 2017/745 sets the clinical evidence for a CE marked device, covering clinical evaluation, investigations, equivalence and PMCF.
Tag: eu
3 posts
EU rules for clinical studies of medical devices
How Regulation (EU) 2017/745 governs clinical investigations of medical devices, which studies it covers and when authorisation or notification is needed.
How the EU classifies medical devices
How Annex VIII of Regulation (EU) 2017/745 assigns medical devices to class I, IIa, IIb or III, and the rules that decide which class applies.