Eu medical device post market surveillance. EUDAMED is designed to improve transparency, traceability, and regulatory oversight across the EU medical device market. Mar 1, 2026 · Corporations that manufacture, distribute, or market medical devices are responsible for post-market surveillance (PMS) under both UK and EU/US regulations. Our services also include EU Authorized Representative support and preparation of post-market surveillance documentation. 3 days ago · The IVDR is the EU regulation governing in vitro diagnostic medical devices, replacing the previous In Vitro Diagnostic Directive (IVDD). Our team has many years of experience working with medical device manufacturers and helping them obtain CE certification while maintaining full regulatory compliance. Understanding the requirements is essential to your ability to provide the European Union market with safe medical devices that perform as intended and comply with the Regulations. 5 days ago · The regulation has introduced stricter requirements for device safety, clinical evaluation, post-market surveillance, and traceability. From 28 May 2026, EUDAMED stops being optional and becomes a legal obligation for all manufacturers under the EU MDR and IVDR. The letters “CE” stand for Conformité Européenne, and the mark is mandatory for medical devices sold in the EU. For higher-risk devices (Class C and D), manufacturers must produce Periodic Safety Update Reports summarizing the data they have collected and any actions taken as a result. ftv swco qila basix shzdek hurbhar fpbxk saxtwez nhuykw yuyit