Technical documentation section:

6. Product verification and validation

This section of the technical documentation demonstrates that the medical device meets the design and safety requirements through verification and validation procedures. It includes objective evidence that the design outputs meet the design inputs and that the product performs safely and effectively under defined conditions of use. Verification and validation activities are planned, controlled, and documented according to the quality management system procedures.

The documentation should address all relevant aspects of product verification and validation, including mechanical, electrical, software, and biological testing, as well as usability and performance evaluations. Each test or evaluation must be traceable to specific design requirements or risk control measures, and the outcomes should confirm compliance with applicable General Safety and Performance Requirements (GSPRs) of the MDR.

This section must also include clinical evaluation documentation to confirm that the clinical benefits outweigh any risks and that the device achieves its intended purpose in the target population.

Below, you will find links to information about the documents included in Section 6 of MDR-compliant technical documentation, covering key requirements for V&V documentation.

• 6.1 Biological evaluation plan →
• 6.2 Biological compatibility tests →
• 6.3 Biological evaluation summary →
• 6.4 Verification plan →
• 6.5 Verification testing →
• 6.6 Verification summary →
• 6.7 Stability and shelf life →
• 6.8 Clinical evaluation plan →
• 6.9 Clinical evaluation report →