Templates
EU MDR essential requirements checklist

EU MDR essential requirements checklist

Navigate the EU MDR requirements with a detailed checklist. Verify compliance, assess documentation, and ensure your medical devices meet regulatory standards.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF
EU MDR essential requirements checklist

Navigate the EU MDR requirements with a detailed checklist. Verify compliance, assess documentation, and ensure your medical devices meet regulatory standards.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

Keep track of your EU MDR compliance journey with this comprehensive essential requirements checklist template. From UDI-DI implementation to post-market surveillance planning, this template covers critical documentation areas required by European regulators. It helps you methodically organize your regulatory submission package, preventing costly oversights and submission delays.

MedTech Europe found that IVD (in vitro diagnostic) manufacturers spend an average of 18 months completing quality management system or technical documentation assessment certification, while MD (medical device) manufacturers spend around 19.5 and 21.8 months, respectively. This template serves as your compliance roadmap so you can track progress across all required documentation areas.

Related categories

Preview of the template
General:
EU Declaration of Conformity
QMS (Quality Management System)
UDI-DI
Safety Performance Summary
Clinical Performance Summary
Risk Management:
Plan
File
Report
Clinical Evaluation:
Plan
Report
Clinical Investigation:
Informed Consent
Application Form
Investigator Pamphlet
Plan
Safety Statement
Performance Statement
Proof of Insurance
Description of Arrangements
Report
Post-Market Surveillance:
Plan
Report
Periodic Safety Update Report
Clinical Follow-Up Plan
Vigilance
Field Safety Corrective Actions
Adverse Event Report
Technical File Documents
Device Description
Device Specification
Instructions of Use
Labels
Design Info
Manufacturing Process
Validations
Site ID
Results of Testing (Pre/Clinical)
This template was downloaded 84 times

Frequently asked questions

What’s the difference between the old MDD essential requirements and the MDR checklist?

The MDR checklist is more comprehensive and stringent. It places greater emphasis on clinical evidence, post-market surveillance, and risk management. The MDR also introduces new requirements like UDI implementation and more detailed technical documentation for higher-risk devices.

How can I ensure my clinical evaluation meets MDR requirements on this checklist?

Focus on demonstrating sufficient clinical evidence specific to your device. The clinical evaluation must follow a defined plan, include thorough literature reviews, and possibly clinical investigations. Ensure you’ve documented benefit-risk determinations and have a plan for ongoing clinical follow-up after market approval.

How do I determine if my risk management documentation is sufficient for MDR?

Your risk management documentation should follow ISO 14971, cover the entire device lifecycle, and demonstrate that all risks have been reduced as far as possible. Ensure you’ve documented the risk-benefit analysis and have plans for ongoing risk monitoring through post-market surveillance activities.

What common mistakes should I avoid when completing this MDR checklist?

Avoid treating the checklist as a mere formality. Each item requires substantial supporting documentation. Don’t underestimate clinical data requirements or post-market surveillance planning. Also, ensure consistency across all documentation, as contradictions between technical file sections are commonly flagged during reviews.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.