Will the Periodic Safety Update Report (PSUR) need to be included in the Clinical Evaluation Report (CER) under MDR? 1.72K 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 MDR requires that the Clinical Evaluation is updated periodically based on Post Market Surveillance (PMS) data. However, inclusion of the PSUR in the CER is optional. The PMS data which the PSUR is based on should be used to update the CER. Spread the love Login
