The Medical Device Regulation (MDR) 2017/745 has significantly enhanced requirements for post-market surveillance (PMS) to ensure the continuous safety and performance of medical devices in the European Union. Manufacturers must establish a robust post-market process to comply with these regulations, maintain market access, and improve patient outcomes. The post-market surveillance system shall be suited to …
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 (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 …