Product Verification & Validation (V&V)
MDR Reference: Annex II, Section 6 (pre-clinical evidence)
BPG Rev.4 Reference: Section 6 (pp. 32-62)
Document Code: AII-S6-VV
MDR Annex II Section 6 requires manufacturers to provide the results of all V&V tests, studies, and assessments that demonstrate conformity with the applicable GSPRs. This section covers pre-clinical evidence including bench testing, biocompatibility, software V&V, electrical safety, sterilisation, packaging, usability, and special pre-clinical studies.
V&V Sub-topics
| Topic | Key Standards | Applicability |
|---|---|---|
| Design V&V (Performance & Safety) | ISO 13485, product-specific standards | All devices |
| Biocompatibility Evaluation | ISO 10993-1:2025 (Ed.6) | Devices with body contact |
| Electrical Safety & EMC | EN 60601-1 (+A13:2024), EN 60601-1-2 | Active electrical devices |
| Software V&V | IEC 62304:2006+A1:2015 (Ed.2 Aug 2026) | Software / SaMD |
| Cybersecurity | EN IEC 81001-5-1:2022, MDCG 2019-16 Rev.1 | Connected software devices |
| Stability & Shelf-life | ASTM F1980, ASTM D4169 | Non-software devices with shelf-life claims |
| Packaging Validation | EN ISO 11607-1/-2 | Sterile / packaged devices |
| Sterilisation Validation | ISO 11135, ISO 11137, ISO 17665 | Sterile devices |
| Usability / Human Factors | IEC 62366-1:2015+A1:2020 | All devices |
| Device Lifetime Validation | Product-specific, MDR GSPR 6.6 | Non-software devices |
| Measuring / Diagnostic Function | Product-specific, MDR GSPR 15 | Measuring / diagnostic devices |
| MRI Safety (Implants) | ASTM F2052/F2213/F2119/F2182, ISO/TS 10974 | Implantable devices |
| Device Interoperability | MDR GSPR 14.5 | Active devices with interfaces |
| Reprocessing Validation | ISO 17664 | Reusable devices |
| Drug-Device Combination | MDR Art.1(8)(9), CTD Module 3 | Drug-device combinations |
| Animal Tissue Devices | Reg (EU) 722/2012, ISO 22442 | Animal-origin tissue devices |
| Human Tissue Devices | MDR GSPR 13.2 | Human-origin tissue devices |
| Absorbed / Dispersed Substances | MDR Rule 21 | Devices with absorbed substances |
| CMR / Endocrine Disrupting Substances | MDR GSPR 10.4.1 | Devices with CMR/ED substances |
General V&V Principles
Per MDR Annex II Section 6.1:
- All V&V results must be critically evaluated, not merely presented
- Each test must be linked to specific GSPRs and/or risk control measures
- For existing devices without new testing: rationale per Annex II 6.1(b) required
- Protocols must include justified sample sizes, acceptance criteria, and confidence intervals
- Worst-case and representative testing must be justified
- Contract test laboratory accreditation/certification must be referenced
- Deviations must be investigated and documented with acceptance rationale
Key Regulatory References
- MDR (EU) 2017/745, Annex II, Section 6
- Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 6
- MDCG Guidance Documents