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
reference
Declaration of Conformity translation requirements — every EU language explained
Which EU language(s) the Declaration of Conformity must be drawn up in, which language(s) must accompany the product per market, and what counts as a valid translation.
reference
Conformity assessment Modules A through H — the EU CE marking decision guide
Every EU conformity assessment module — Module A self-assessment through Module H full quality assurance — when each applies and how to choose the right one.
guide
When you need a Notified Body — the EU CE marking decision guide
Decision guide for when a Notified Body must be involved in EU conformity assessment — by directive, by product type, by module — plus how to find one and what it costs.
guide
CE Marking 101 — the complete EU guide for hardware manufacturers
End-to-end CE marking guide for 2026: which products need it, the 24 directives behind it, the conformity assessment process, common mistakes, and penalties.
guide
EU Authorised Representative (EC REP) — the complete guide for non-EU manufacturers
Complete EC REP guide for non-EU manufacturers: when required, responsibilities under CRA, RED, MDR, the mandate document, costs, and how to choose a representative.
guide
Technical File 101 — what it must contain and how to maintain it
Complete guide to the EU Technical File: required content per directive, software-specific additions under CRA, retention rules, format, and common mistakes.
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