6.6 Verification report (MDR)

The verification report is a formal document that summarizes the execution and outcomes of all verification activities performed on the medical device. It provides documented evidence that the device meets the predefined design inputs and complies with relevant regulatory requirements under MDR.

Content and structure

This report consolidates the results of individual verification tests and demonstrates traceability to the corresponding design specifications. It contains the following key elements:

• reference to the approved verification plan
• summary of verification methods used
• list of all tests performed with identifiers
• test results and acceptance status
• deviations encountered and their resolution
• overall conclusion on conformity
• name and qualification of the responsible reviewer

Conclusion and regulatory relevance

The verification report provides final confirmation that the device design has been properly verified. It plays a critical role in demonstrating conformity with the General Safety and Performance Requirements under Annex I of MDR and forms a core component of the device’s technical documentation.

This report must be signed and dated by a qualified individual and kept up to date in the event of design changes or further testing.