EU MDR Transition Deadlines: What Regulation (EU) 2023/607 Means for Your Legacy Devices
MDR transition deadline explained: the 2027 and 2028 dates under Regulation (EU) 2023/607, the conditions legacy devices must meet, and the common traps.
EU MDR Technical Documentation: Building an Annex II and III File That Survives Review
What EU MDR Annex II and III require in a technical file, how notified bodies expect it laid out, and the gaps that cost manufacturers a review cycle.
EU MDR Classification Rules: Annex VIII Applied to Four Real Devices
How to classify a medical device under Annex VIII of the EU MDR, with worked examples for needles, dressings, monitors and software, and the usual errors.
How to Choose a Notified Body Under EU MDR: The Checks to Do First
Which notified body should you apply to for CE marking? A step-by-step selection method using NANDO designation codes, Article 52 routes and fees.
EUDAMED: the 28 November 2026 deadline for devices already on the EU market
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: Compliance Guide for IVD Manufacturers
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: Compliance Guide for Manufacturers (2026)
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.
Technical Documentation under EU MDR 2017/745
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:…
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: Post-Market Surveillance System Importance of Technical Documentation The…
