RegulationIllustrative imageMedical Device Regulation (MDR)
The core EU framework for medical devices, covering classification, conformity assessment, clinical evaluation, post-market surveillance and traceability through UDI.
The regulation applies to devices and accessories placed on the Union market, and sets out obligations for manufacturers, authorised representatives, importers and distributors according to their role in the supply chain. Classification follows Annex VIII, with risk class driving the conformity assessment route and the level of notified body involvement.
Manufacturers must establish and maintain a quality management system, compile technical documentation for each device, and carry out a clinical evaluation supported by clinical data. For higher-risk devices the assessment includes scrutiny of the clinical evaluation by the notified body, and for class III implantable devices an additional consultation procedure applies.
Post-market obligations are continuous rather than one-off. A post-market surveillance plan, periodic safety update reports at defined intervals, and a post-market clinical follow-up plan are required, with serious incidents reported through the vigilance system within the statutory timelines.
Traceability rests on the unique device identification system. A basic UDI-DI identifies the device grouping, UDI-DIs identify each configuration, and the identifiers must be registered in EUDAMED and carried on labelling and, for reusable devices, on the device itself.
Important: this page is an editorial summary for demonstration purposes. It is not legal advice and does not replace the official text. Always rely on the consolidated version published in the Official Journal of the EU and on qualified regulatory advice.