Typical timeline
6–18 months
Same practical timeline as achieving CE Marking, since MDR compliance is the prerequisite for the mark.
European Union
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
The documentation and evidence a complete submission is normally built from.
- 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
Planning ranges
Typical timeline and estimated cost
Ranges illustrate general market patterns for this pathway — they are not a quote for a specific product.
Estimated cost
$15k–$150k
Cost scales with device class and clinical evidence burden — see CE Marking for a breakdown by class.
Timelines and costs above are typical ranges illustrating general market patterns, not a quote or regulatory conclusion for your specific product. Actual figures depend on device classification, target country, and applicant readiness — professional review is required before relying on this for a business decision.
Where this applies
Applicable countries
Jurisdictions that recognise this certification. Scope and conditions still vary by product classification.
all EU/EEA member states
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.
View →
IVDR
The EU regulation governing in vitro diagnostic devices — the IVD counterpart to the MDR.
View →
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
View →
Reviewed packages
Buy a defined outcome
Pay for a market-access outcome — not a feature tour
Market Entry Sprint from $2,500 · Strategy Session $500 · Pathway Brief $1,800. Professional review required before business use. No patient data on public forms.
Reviewed launch planning
Need a EU MDR pathway brief?
EU MDR pathway briefs start at $1,800. Or book a $2,500 Market Entry Sprint that includes regulatory pathway outline, evidence flags, and a review call.
Professional review is required before business use.