EU Medical Device Regulation Compliance Checklist
Use this checklist to verify whether a medical device documentation set appears ready for EU Medical Device Regulation (MDR) compliance review.
Device Name
*
Device Model or Reference Number
Documentation Set Version/Date
Reviewer Name
First Name
Last Name
Are the following documentation elements complete and available?
Technical Documentation (Annex II & III) is present and up to date
*
Yes
No
Not Applicable
Clinical Evaluation Report (CER) is present and meets MDR requirements
*
Yes
No
Not Applicable
Risk Management Documentation (ISO 14971) is available and current
*
Yes
No
Not Applicable
Post-Market Surveillance (PMS) Plan and Reports are included
*
Yes
No
Not Applicable
Declaration of Conformity (DoC) is signed and included
*
Yes
No
Not Applicable
Labeling and Instructions for Use (IFU) are present and MDR-compliant
*
Yes
No
Not Applicable
UDI (Unique Device Identification) information is included and properly documented
*
Yes
No
Not Applicable
Additional Comments or Notes
Submit Checklist
Should be Empty: