This MDR hub explains how Regulation (EU) 2017/745 applies to a medical device, accessory, medical-device software or Annex XVI product, then connects that scope decision to classification, market access and lifecycle evidence.
Follow the recommended path from scope and operator role to classification, conformity assessment, technical and clinical evidence, /, post-market controls and conditional legacy-device transition. Since 28 May 2026, the EUDAMED Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance modules have been mandatory; the Clinical Investigations and Vigilance/PMS modules follow the separate gradual-rollout timetable. documents explain practical approaches but do not replace the binding Regulation or implementing acts.
Start with the manufacturer's and EU supply-chain role. Then justify the class, choose the Article 52 conformity route, and keep quality, technical, clinical and post-market records aligned for the device's full lifecycle.
Focused MDR guidance
Start with the Summary of Safety and Clinical Performance (), the public safety and clinical evidence summary required for specified devices under the EU Medical Device Regulation (MDR). Use the guide library below for qualification, classification, conformity assessment, clinical evidence, and lifecycle work.
requires an for implantable and devices, except custom-made and investigational devices. For example, a class IIb dental implant needs one because it is implantable, while a non-implantable class IIb imaging system does not. Follow Medical Device Coordination Group () guidance for the content, notified-body validation, translations, and publication process.
Read the SSCP answerTrack MDR application, Article 120 legacy-device conditions and the applicable 31 December 2027 or 31 December 2028 transition end date, application and agreement evidence, technical documentation updates, clinical evaluation and PMCF outputs, PMS/vigilance records, assignment, applicable mandatory actor and device registration, certificate status, and market-surveillance correspondence for each device family.
New to the MDR? Start by documenting , product qualification and economic-operator role. If scope is settled, jump to classification, conformity assessment, technical or clinical evidence, traceability, transition, post-market controls, enforcement or a focused comparison.
Decide whether the product is a medical device, accessory, medical-device software, Annex XVI product or an interface with another regime before classification begins.
Apply Annex VIII to the documented device facts, resolve software and special-rule questions, select the Article 52 route and confirm the notified body's designation scope where third-party assessment is required.
Turn manufacturer and supply-chain duties into owned controls, a traceable Annex II and III file, GSPR and risk evidence, supplier records and release gates that reopen when the device changes.
Connect the clinical evaluation plan and report to GSPRs, benefit-risk, equivalence limits, clinical investigations, PMCF, PMS signals and notified-body review.
Control actor and device data separately from conditional Article 120 transition claims, and distinguish fixed legal dates from recurring internal review events.
Route complaints and signals through PMS, PMCF, PSUR or PMS reporting, vigilance clocks, FSCA and CAPA decisions, technical-file updates and national enforcement follow-up.
Keep MDR qualification and evidence distinct from adjacent regimes, or go directly to the FAQ for a specific question about software, accessories, clinical evidence, UDI, EUDAMED or transition.
This hub helps route MDR work by device family, , risk class, economic-operator role, status, clinical evidence route and EU market path. Build a controlled device file that stays current throughout the lifecycle.
