📋 Quick Summary
EU MDR and IVDR requirements for medical device manufacturers. Clinical evaluation, technical documentation, notified body selection, and EUDAMED registration.
📬 Get daily updates like this in your inbox. Subscribe to RegWatch Daily →
The Regulatory Landscape After MDR and IVDR
The EU Medical Device Regulation (MDR 2017/745) fully replaced the Medical Device Directive in May 2021. The EU In Vitro Diagnostic Regulation (IVDR 2017/746) completed its transition in May 2022 for the highest-risk IVD classes, with lower-risk classes continuing on a rolling timeline through 2027.
The transition is not cosmetic. MDR and IVDR impose substantially higher clinical evidence requirements, expanded notified body audit scope, ongoing post-market surveillance obligations under Articles 83 through 86, and mandatory registration in EUDAMED for all devices on the EU market. Manufacturers operating under legacy MDD or IVDD CE marks must have transitioned or are working under transitional provisions.
Clinical Evaluation Under MDR Article 61
MDR Article 61 requires manufacturers to demonstrate conformity with the general safety and performance requirements in Annex I through clinical evaluation. For most Class IIa, IIb, and III devices, this requires a Clinical Evaluation Report (CER) that systematically appraises published literature on the device and equivalent devices, along with clinical investigation data where literature evidence is insufficient.
The equivalence pathway under MDR is substantially narrower than under MDD. To claim equivalence with another manufacturer's device, you must have a contract providing access to their technical documentation. Most manufacturers do not have such contracts. This has forced many Class IIb and III manufacturers into clinical investigations who previously relied on equivalence.
Technical Documentation Structure Under MDR Annex II
MDR Annex II defines the structure of the technical documentation that must be maintained and made available to competent authorities and notified bodies. The structure differs meaningfully from MDD technical files. Key additions include the Summary of Safety and Clinical Performance (SSCP) for implantable devices and Class III devices, which must be publicly available in EUDAMED.
Notified body audits under MDR have broader scope than under MDD. Auditors review the entire quality management system under ISO 13485, the technical documentation for a sample of products, and your post-market surveillance system. The surveillance audit cadence has increased — most notified bodies conduct unannounced audits at least once per certification cycle.
Get this intelligence in your inbox every morning.
Daily regulatory briefings for QA managers, SaMD teams, and startup RA leads — personalized, actionable, free.
Subscribe Free →Free forever. Unsubscribe anytime.
Post-Market Surveillance Requirements Under Articles 83-86
MDR Articles 83 through 86 establish mandatory post-market surveillance requirements that go significantly beyond what MDD required. Article 83 requires a PMS plan for every device. Article 84 requires a Post-Market Surveillance Report (PMSR) for Class I devices updated annually, and a Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices.
The PSUR must summarize all complaints, field safety corrective actions, post-market clinical follow-up data, and benefit-risk conclusions. For Class IIb and III devices, PSURs must be submitted to your notified body. This ongoing obligation means your complaint handling system, PMCF methodology, and benefit-risk analysis process need to be designed to feed PSUR generation from the start of commercial distribution.
📚 Sources & References
Get this intelligence in your inbox every morning.
Daily regulatory briefings for QA managers, SaMD teams, and startup RA leads — personalized, actionable, free.
Subscribe Free →Free forever. Unsubscribe anytime.
Get the EU MDR/IVDR Compliance Kit — 6 documents covering IVDR transition, clinical evaluation, technical documentation, and notified body preparation.
Get the EU MDR Compliance Bundle — $347