In vitro diagnostic medical devices

Draft Commission Implementing Regulation amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council; (4 page(s), in English), (41 page(s), in English)

This draft Commission Implementing Regulation adds common specifications for some high-risk in vitro diagnostic medical devices in accordance with Art. 9 of Regulation (EU) 2017/746, notably in relation to their performance evaluation. It also makes a number of editorial corrections to existing specifications.