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EU MDR Must-Have Documents Template

When it comes to the distribution of medical products in the EU, there are certain protocol and requirements that must be met per their standard, for safety and quality reasons. Along with following these standards, there are certain items that must be documents in accordance with the EU MDR regulations. There are several documents that are not necessary to record, but many that are vital in order to cooperate with the requirements of the EU MDR. This coherent EU MDR Documents Template will guide you in knowing which items must be documented as per the European Union standard. Using this template along with other resources Lumiform has to offer, like our Digital Documentation App that will keep all of your data accessible and consistent across your entire team, for the most accurate results.

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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)
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Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
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