EU MDR 2017/745

EU MDR Consulting &
CE Marking

EU MDR 2017/745 is one of the most demanding medical device regulatory frameworks in the world. Clinical evidence requirements, Notified Body scrutiny, and post-market obligations have all increased significantly from the old MDD. We navigate the full EU MDR pathway — Technical Documentation, Clinical Evaluation, and everything in between.

Technical Documentation Clinical Evaluation (CER) Notified Body Liaison EUDAMED Registration PMCF / PSUR Class I · IIa · IIb · III
Discuss EU MDR Strategy
EU MDR Device Classification

Classification Determines Everything

Under EU MDR, your device class drives the depth of Technical Documentation required, Notified Body involvement, and the stringency of clinical evidence expectations.

I

Class I

Self-declared conformity. Technical File, Declaration of Conformity, EU Authorized Representative. No Notified Body required (except sterile, measuring, or reusable surgical instruments).

IIa

Class IIa

Notified Body QMS audit + Technical Documentation review. Full CE marking with NB certificate. Comprehensive CER required. Annual PSUR and PMCF plan.

IIb

Class IIb

NB type examination. Full QMS certification plus design verification. More stringent CER. Annual PSUR, active PMCF study in most cases.

III

Class III

Highest scrutiny. Clinical investigation typically required. Full Notified Body certification including design dossier. SCENIHR consultation possible. Rigorous PMCF.

EU MDR Services

Full EU MDR Coverage

Technical Documentation
Complete Technical File preparation per EU MDR Annex II and III — device description, design and manufacturing info, safety and performance, labeling, and risk management.
Clinical Evaluation (CER)
Comprehensive CER per MEDDEV 2.7/1 Rev 4 and EU MDR Annex XIV — literature review, equivalent device analysis, clinical data appraisal, and ongoing update plan.
Notified Body Management
NB selection guidance, audit preparation, technical Q&A management, and response to NB findings — we act as your technical interface throughout the certification process.
PMCF & PSUR
Post-Market Clinical Follow-up study design and Periodic Safety Update Reports — meeting EU MDR's ongoing post-market obligations for all device classes.
EUDAMED Registration
UDI assignment, EUDAMED actor and device registration, and certificate upload — complete EU database compliance from initial registration through ongoing maintenance.
SSCP Preparation
Summary of Safety and Clinical Performance — mandatory for implantable and Class III devices. Plain-language summaries validated against clinical data and reviewed by HCPs.
Key Difference from FDA

What EU MDR Demands That FDA Doesn't

If you have FDA clearance and plan to pursue CE marking, here's what you'll need to add or significantly expand:

Clinical Evaluation Report (CER) — Much more demanding than FDA clinical evidence requirements, especially for Class IIb and III
EUDAMED Registration — Mandatory EU database, no FDA equivalent
UDI labeling — EU MDR UDI requirements differ from FDA UDI rules
PMCF Studies — Active post-market clinical follow-up, not just complaint monitoring
EU Authorized Representative — Required for non-EU manufacturers

Planning your EU MDR CE marking strategy?

Start with a free discovery call — we'll assess your device class and what the Technical Documentation will require.

Book a Free Call