EU Regulation · MDR
Medical Device Regulation
Regulation (EU) 2017/745
The Medical Device Regulation governs the safety and performance of medical devices in the EU. Conformity routes scale with risk class, and most classes above the lowest require a Notified Body to assess conformity before CE marking.
What it covers
Medical devices and their accessories of any risk class placed on the EU market.
How it applies to your product
Under the MDR the conformity route scales with risk class: most Class I devices self-declare (sterile, measuring or reusable-surgical Class I still need limited Notified Body involvement), while Class IIa and above require a Notified Body to assess the technical documentation or quality system before CE marking. Software can itself be a medical device, and its classification drives the whole route.
Authoritative source
Always confirm against the primary text on EUR-Lex — the official EU legal database.
Read Regulation (EU) 2017/745 on EUR-Lex ↗See also the MDR entry in the glossary.
Guides on MDR
From the Library
tutorial
How to check NANDO for Notified Bodies
Step-by-step guide to NANDO — the Commission's public database of Notified Bodies. Search by Directive, by 4-digit ID, by country, and verify a quoted NB number on a DoC.
guide
CE marking medical wearables — MDR + CRA overlap
How CE marking works for a medical wearable: MDR is binding, CRA is carved out by Article 2(2), and RED still applies to the wireless side.
guide
EC REP cost guide 2026: what you pay, what you get, what to avoid
Cost guide for EU Authorised Representative services in 2026 by directive — CRA Article 18, RED Article 11, MDR Article 11 — what drives premium and how to verify a quote.
comparison
EC REP vs Importer: Responsibilities Under CRA, RED, and MDR
EC REP vs Importer — the two distinct EU economic operator roles, their obligations under CRA, RED, MDR, and Regulation 2019/1020, and when one entity can be both.
reference
Technical File retention requirements per EU directive
How long the Technical File must be retained under each major CE marking directive in 2026 — CRA, RED, MDR, LVD, EMC, Machinery, with the specific article cited.
guide
Risk assessment for CE compliance — methodology overview and standards reference
Overview of the risk assessment methodologies that satisfy CE marking directives — Machinery, MDR, CRA — and the harmonised standards each cites.
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