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.
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CE marking medical wearables — MDR scope, CRA exclusion and radio requirements
A concise overview of medical-device classification, non-EU representation, documentation and the MDR exclusion from CRA for in-scope medical wearables.
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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
Selected documentation-retention and availability duties under CRA, MDR, RED and machinery legislation, with product-specific evidence and source references.
guide
Risk assessment for CE compliance — methodology overview and standards reference
How to document product-specific safety and cybersecurity risks, choose methods within their verified scope, and connect risk controls to conformity evidence.
Check your product