Technical documentation section 6. Verification & validation:
6.4 Verification plan under MDR
The verification plan defines the structured approach and methodology that will be used to confirm that the medical device meets its specified design requirements. It is a core element of the product development and design control process, supporting compliance with MDR and relevant harmonized standards such as ISO 13485 and ISO 14971.
Purpose and scope
The purpose of the verification plan is to outline how the design inputs will be systematically verified through appropriate methods, such as inspection, testing, and analysis. It applies to all critical aspects of the device that impact its performance, safety, and regulatory compliance.
Content of the verification plan
The verification plan typically includes:
- list of design inputs to be verified
- verification method and acceptance criteria for each input
- description of test equipment and protocols
- responsible personnel and timelines
- traceability matrix linking inputs to verification activities
Verification methods
Verification activities may include visual inspection, functional testing, dimensional measurements, simulation, software tests, and laboratory analysis. All methods must be justified, documented, and capable of demonstrating objective evidence of conformity with the design specifications.
Regulatory alignment
The verification plan must be consistent with the overall quality management system and must ensure alignment with MDR requirements, particularly Annex II and Annex III. It also contributes to the risk management process by confirming the effectiveness of design risk controls identified during development.
Outcome and documentation
Successful execution of the verification plan results in a verification report that summarizes the findings, deviations (if any), and conclusion on whether the design outputs meet the predefined inputs. This report becomes part of the device’s technical documentation.
