Is the Technical Documentation assessment for Class IIb implantable devices based on a representative sample of the generic device group under MDR? 1.47K viewsOctober 10, 2022Medical Device 0 Sam Smith11.38K October 19, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 19, 2020 0 Comments Spread the loveThe language in the MDR suggests that Class IIb implantable devices will need a detailed Technical Documentation review analogous to a Class III device under the current MDD. Hence sampling may not be possible. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login