psur

MDCG 2020-21 PSUR Guidance has been published

The guidance document MDCG 2020-21– Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 which is highly anticipated has been published on 16 December 2022 by MDCG. The guidance document, which provides information about the content, format and frequency of preparation for the PSUR, which must be prepared during and after the …

PMCF, PMS and PSUR Requirements

PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and market surveillance.  The importance of the clinical data shows its effects for post market surveillance as a more detailed PMCF process. Of course this shall …