Glossary · EU medical devices: MDR
Medical Device Regulation (MDR)
Also known as: MDR, EU MDR, Regulation (EU) 2017/745, EU Medical Device Regulation
The EU Medical Device Regulation, Regulation (EU) 2017/745, is the EU law that sets the requirements for placing medical devices and certain products without a medical purpose on the EU market. It has applied since May 26, 2021 and replaced the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC.
- EU
- MDR
In one sentence
The EU Medical Device Regulation (EU) 2017/745 governs medical devices on the EU market. It has applied since May 26, 2021, replacing two directives.
Example
A manufacturer of infusion pumps that held a certificate under Directive 93/42/EEC rebuilds its technical documentation to MDR Annexes II and III, sets up an MDR-compliant post-market surveillance system and applies to a notified body for MDR certification.
How it applies
- Scope: The MDR covers medical devices, their accessories and the products without an intended medical purpose listed in Annex XVI. In vitro diagnostics fall under the separate IVDR.
- Lifecycle obligations: It places duties on every economic operator, from classification and conformity assessment through clinical evaluation to post-market surveillance and vigilance.
- Transparency: Devices carry a UDI, and actors, devices, certificates and incidents are registered in EUDAMED.
- Transition: Legacy devices with valid directive certificates may stay on the market until the end of 2027 or 2028 under conditions; see transition periods. Regulation (EU) 2024/1860 added Article 10a on the anticipated interruption or discontinuation of supply.
- Change ahead: In December 2025 the European Commission proposed a targeted revision of MDR and IVDR. It is a proposal, not applicable law; check the current status.
- Technical documentation: The MDR requires technical documentation to Annexes II and III, kept up to date across the device lifecycle, as the basis for the EU declaration of conformity and CE marking.
MDR vs. Medical Devices Directive
The directive had to be transposed into national law and left room for national differences; the MDR applies directly in every member state. It also tightened the rules on clinical evidence, notified body oversight, post-market surveillance, traceability through UDI and public transparency through EUDAMED. A device certified under the directive is not automatically MDR-compliant.