Verification and validation of medical devices: the EU approach in simple words
The development of a medical device involves multiple steps to ensure its safety, reliability, and effectiveness. Two critical processes in this journey are verification and validation (V&V). These steps confirm that a medical device meets regulatory requirements and performs as intended before reaching the market.
What is verification of medical devices?
Verification is the process of confirming that a medical device meets the specified design requirements. It involves testing, inspections, and document reviews to ensure that all design inputs (e.g., materials, dimensions, software requirements) match the expected outputs.
Key characteristics of verification:
- Ensures that the product is built correctly according to specifications.
- Focuses on technical and design aspects rather than functionality in a real-world setting.
- Uses objective evidence, such as lab testing, inspections, and design reviews.
Examples of verification:
- Mechanical testing of an implantable device: A hip implant manufacturer tests the material strength and fatigue resistance to verify that it can withstand daily wear and tear.
- Software verification in a medical imaging system: Developers ensure that the software meets its design specifications by testing individual modules (e.g., confirming that an X-ray machine correctly processes image files).
- Inspection of a blood pressure monitor's components: Checking the accuracy of sensors and ensuring that the casing meets size and durability requirements.
What is validation of medical devices?
Validation is the process of confirming that a medical device performs as intended in real-world conditions and meets user needs. It ensures that the device provides the expected clinical benefits to patients and healthcare professionals.
Key characteristics of validation:
- Ensures that the right product has been built for its intended use.
- Involves real-world clinical testing, usability studies, and performance evaluations.
- Often conducted under actual or simulated use conditions to assess effectiveness and safety.
Examples of validation:
- Clinical validation of a diabetes glucose monitor: The device is tested on actual patients to confirm that it provides accurate blood glucose readings under normal use.
- Usability testing of an infusion pump: Healthcare professionals use the pump in a hospital setting to ensure it is easy to operate, minimizes user errors, and delivers medication correctly.
- Performance validation of a surgical robot: A robotic-assisted surgery device is tested in simulated operating room conditions to validate its accuracy, precision, and response time.
Key differences between verification and validation
| Aspect |
Verification |
Validation |
| Objective |
Confirms the device meets design specifications. |
Ensures the device works as intended for users. |
| Method |
Lab tests, inspections, technical reviews. |
Clinical trials, user testing, performance evaluation. |
| Focus |
Design correctness. |
Functional effectiveness in real-world conditions. |
| Examples |
Checking software code, material strength tests. |
Testing usability with healthcare professionals. |
Regulatory requirements for verification and validation
MDR and IVDR requirements (EU)
Under MDR 2017/745 and IVDR 2017/746, medical device manufacturers must provide documented evidence of verification and validation to receive CE marking.
- Verification is covered in the technical documentation (Annex II & III), requiring proof that the device meets design inputs.
- Validation includes clinical evaluations and performance studies to demonstrate real-world safety and effectiveness.
Conclusion
Verification and validation are critical steps in ensuring that medical devices meet regulatory requirements and provide safe, effective solutions for patients.
