Medical Device Regulation (MDR)
The EU regulation governing the placing on the market of medical devices, applying since May 2021 in place of the Medical Devices Directive. It raises the bar on clinical evidence, post-market surveillance, unique device identification (UDI), and the role of notified bodies, and requires a compliant quality management system throughout the device lifecycle.
Medical devices placed on the EU market — from classification and conformity assessment through clinical evaluation, UDI, and post-market surveillance.
- 01Determine device classification and the correct conformity-assessment route
- 02Maintain clinical evaluation and post-market clinical follow-up evidence
- 03Operate post-market surveillance and vigilance/incident reporting
- 04Assign UDI and register devices/actors in EUDAMED
- 05Maintain an ISO 13485-aligned quality management system
Applying since 26 May 2021 (transition provisions extended by Regulation (EU) 2023/607), replacing Directive 93/42/EEC with stronger clinical, PMS, and traceability requirements.
Regulation (EU) 2017/745: frequently asked questions
Quick answers to common questions about Regulation (EU) 2017/745.
What is Regulation (EU) 2017/745?
Regulation (EU) 2017/745 — Medical Device Regulation (MDR) — is a regulation issued by the European Commission — EudraLex (European Union). The EU regulation governing the placing on the market of medical devices, applying since May 2021 in place of the Medical Devices Directive. It raises the bar on clinical evidence, post-market surveillance, unique device identification (UDI), and the role of notified bodies, and requires a compliant quality management system throughout the device lifecycle.
Who does Regulation (EU) 2017/745 apply to?
Medical devices placed on the EU market — from classification and conformity assessment through clinical evaluation, UDI, and post-market surveillance.
What are the key requirements of Regulation (EU) 2017/745?
EC Regulation (EU) 2017/745 requires, among other things: Determine device classification and the correct conformity-assessment route; Maintain clinical evaluation and post-market clinical follow-up evidence; Operate post-market surveillance and vigilance/incident reporting; Assign UDI and register devices/actors in EUDAMED.
When was Regulation (EU) 2017/745 last updated?
The current version of Regulation (EU) 2017/745 dates from May 2021. Applying since 26 May 2021 (transition provisions extended by Regulation (EU) 2023/607), replacing Directive 93/42/EEC with stronger clinical, PMS, and traceability requirements.
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When Regulation (EU) 2017/745 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.