EU medical device regulation explained: MDR 2017/745, IVDR, technical documentation, EUDAMED, UDI, notified bodies and CE marking for manufacturers.
EUDAMED registration for devices already on the EU market closes on 28 November 2026. What MDR and IVDR manufacturers, authorised representatives and importers must check now.
EU IVDR 2017/746 explained: Annex VIII classification, transition deadlines to 2029, performance evaluation under Annex XIII, Class D obligations and EUDAMED registration.
EU MDR 2017/745 explained for non-EU manufacturers: transition deadlines to 2027 and 2028, the 27 November 2026 EUDAMED deadline, Authorised Representative and PRRC duties, and technical documentation.
Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device’s conformity to the regulations. It’s essential for both pre-market and post-market compliance. This documentation must be readily accessible to regulatory authorities for inspection. Annex II: Technical Documentation Annex III:…
Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device’s conformity to the regulations. It’s essential for both pre-market and post-market compliance. This documentation must be readily accessible to regulatory authorities for inspection. Annex II: Technical Documentation Annex III: Post-Market Surveillance System Importance of Technical Documentation The…
