EU MDR (Regulation 2017/745)
The EU regulation that defines medical device requirements — CE Marking is the certification mark it produces once satisfied.
Overview
What EU MDR is and why it matters
Regulation (EU) 2017/745 replaced the Medical Device Directive and significantly tightened clinical evidence, post-market surveillance, and Notified Body oversight requirements across the EU. It applies to essentially all medical devices (excluding in vitro diagnostics, which fall under IVDR) placed on the EU/EEA market.
Requirements
What you'll need
- Risk-based classification under Annex VIII
- General Safety and Performance Requirements (Annex I) compliance
- Technical documentation (Annex II/III)
- Clinical evaluation and, where required, clinical investigation
- Person Responsible for Regulatory Compliance (PRRC) designated
- EUDAMED registration and UDI
- Post-market surveillance and periodic safety update reports
Typical timeline
6–18 months
Same practical timeline as achieving CE Marking, since MDR compliance is the prerequisite for the mark.
Estimated cost
$15k–$150k
Cost scales with device class and clinical evidence burden — see CE Marking for a breakdown by class.
Where this applies
Applicable countries
Related
Regulatory Pathways
FAQ
Frequently asked questions
How is MDR different from IVDR?+
MDR covers general medical devices; IVDR covers in vitro diagnostics specifically, with its own classification system and a much larger share of devices now requiring Notified Body review than under the prior IVDD.
What happens to devices certified under the old MDD?+
Legacy MDD certificates remain valid only until their stated expiry or applicable transition deadline — manufacturers should confirm current deadlines with their Notified Body, as these have shifted more than once since 2021.
Related
Related Certifications
CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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IVDR
The EU regulation governing in vitro diagnostic devices — the IVD counterpart to the MDR.
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ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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