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.
Tag: classification
2 posts
How FDA classifies medical devices
How FDA assigns devices to class I, II or III under 21 CFR Part 860, covering classification regulations, De Novo requests and 510(k) exemptions.