EU MDR
EU MDR compliance checklist
Use this working list to organize evidence for Regulation (EU) 2017/745. Requirements vary by device, risk class and role; confirm your route with the applicable competent authority or notified body.
Each item shows live U.S. FDA inspection findings and warning-letter citations on the same quality topic, a guide to where regulators most often find problems. Track your own progress on the compliance dashboard.
EUDAMED registration
Official EU guidance- Confirm the responsible economic operator and authorised representative, when required.
- Register the economic operator and obtain a Single Registration Number (SRN).
- Assign the Basic UDI-DI and UDI-DI through an approved issuing entity.
- Register device and certificate details using the applicable EUDAMED or transitional national process.
- Define ownership for keeping actor, device and certificate records current.
Technical documentation and CE marking
Official EU guidance- Confirm the device's intended purpose, qualification, classification and applicable classification rule.
- Prepare technical documentation under MDR Annexes II and III, including risk management and verification evidence.
- Select the conformity assessment route and engage a notified body when the class or device type requires one.
- Complete the EU declaration of conformity before applying the CE mark.
- Check labelling, instructions for use, language requirements and authorised-representative details.
Clinical evaluation
Official EU guidance- Maintain a clinical evaluation plan tied to the intended purpose, benefits, risks and clinical claims.
- Identify, appraise and analyse relevant clinical data, including equivalent-device evidence where justified.
- Document conclusions and remaining evidence gaps in the clinical evaluation report.
- Determine whether a clinical investigation is required and document the rationale.
- Keep the clinical evaluation aligned with risk management and post-market clinical follow-up.
Post-market surveillance
Official EU guidance- Maintain a post-market surveillance plan proportionate to the device and its risks.
- Collect complaints, literature, trend, vigilance and field safety corrective action data.
- Prepare the required PMS report or periodic safety update report and update it at the required cadence.
- Maintain post-market clinical follow-up where applicable and feed results into the clinical evaluation.
- Define serious-incident, trend and field-safety reporting procedures and timelines.
This checklist is an organizational aid, not legal advice or a determination that a device complies with the MDR.