Product Verification & Validation

MDR Reference: Annex II, Section 6 (pre-clinical)
BPG Rev.4 Reference: Section 6 (pp. 32-62)
Document Code: AII-S6-VV
Responsible Party: Manufacturer (Client) / CRO (biocompatibility evaluation)
Service Mode: Assist / Review

Detailed V&V sub-topic guides are available: See the V&V Overview page for individual guides on each V&V area including biocompatibility, software V&V, electrical safety, cybersecurity, sterilisation, packaging, usability, and more.

General V&V Requirements Checklist

• [ ] Results and critical evaluation of all V&V tests/studies
• [ ] Each test linked to specific GSPRs and/or risk control measures
• [ ] For existing devices without new testing: rationale per Annex II 6.1(b)
• [ ] All design requirements and specification documents provided
• [ ] Design control input/output traceability matrix (requirements -> V&V evidence)
• [ ] Overarching design V&V plan(s) and associated report(s)
• [ ] For historic testing: clear identification of which reports apply to current device version
• [ ] Protocols: justified sample sizes (standards-based or risk-based), acceptance criteria, confidence intervals
• [ ] Worst-case and representative testing justification
• [ ] Pre-conditioning documented in advance with data included in reports
• [ ] Deviations/discrepancies investigated and documented with acceptance rationale
• [ ] Contract test laboratory accreditation/certification referenced
• [ ] Device lifetime evidence (distinct from shelf life)
• [ ] For AI/ML devices: training/testing datasets, tools, environments, V&V protocols/reports, EU Ethics guidelines compliance

6.1 Pre-Clinical Data

6.1.1 Biocompatibility (per ISO 10993 series)

• [ ] Standards and references applied for biological evaluation
• [ ] Personnel qualification (biological evaluation, toxicological risk assessment)
• [ ] Device formulation/family description
• [ ] Manufacturing impact on materials (passivation, sterilisation, etc.)
• [ ] Nature and duration of body contact categorisation
• [ ] Potential biological risks and hazards identification
• [ ] Chemical characterisation per ISO 10993-1 and -18
• [ ] Extractable & leachable testing (if required)
• [ ] Toxicological risk assessment per ISO 10993-17 (if applicable)
• [ ] Testing program determination (considering animal welfare)
• [ ] Test reports with method, standard, laboratory competence, conditions, results
• [ ] Laboratory ISO/IEC 17025 accreditation or GLP certificate
• [ ] Overall Biological Evaluation Report (BER) with safety conclusion
• [ ] Reference to risk management file and PMS data

6.1.2 Software V&V (EN 62304 / Cybersecurity)

• [ ] Statement and rationale for medical device qualification
• [ ] Software safety classification per EN 62304 with justification
• [ ] Software version under application clearly identified
• [ ] Standards compliance checklist with direct TD references
• [ ] Software development plan and lifecycle requirements
• [ ] Development environment description (tools, settings, configurations)
• [ ] Software requirements analysis (functional, non-functional, GSPR 17.4, cybersecurity)
• [ ] Software architectural design (requirements allocated to software items, SOUP list)
• [ ] Software detailed design (Class B & C: unit-level design data)
• [ ] SOUP list (name, version, manufacturer, functional/performance requirements)
• [ ] V&V plans, protocols, reports (in-house and simulated/actual use)
• [ ] Test environment documentation
• [ ] Automated testing scripts and test log results
• [ ] Hardware and OS compatibility verification
• [ ] Mobile platform compliance with GSPR 17.3 (if applicable)
• [ ] Traceability matrix (testing -> specifications)
• [ ] For AI/ML: questionnaire per Team-NB "AI in Medical Devices"
• [ ] Cybersecurity documentation per MDCG 2019-16

6.1.3 Electrical Safety & EMC

• [ ] EN 60601-1 compliance evidence
• [ ] EN 60601-1-2 (EMC) compliance evidence
• [ ] Additional collateral/particular standards (EN 60601-1-X, EN 60601-2-X)

6.1.4 Packaging, Stability & Shelf-Life

• [ ] Packaging validation (seal strength, distribution, etc.)
• [ ] Accelerated aging studies with justification
• [ ] Real-time aging studies (or justification for absence)
• [ ] Shelf-life claims supported by data

6.1.5 Performance & Safety Testing

• [ ] Design verification and validation protocols/reports
• [ ] Measuring/diagnostic function accuracy (GSPR 15)
• [ ] MR compatibility (if applicable)
• [ ] Mechanical performance testing

6.1.6 Usability

• [ ] Usability engineering per EN 62366-1
• [ ] Formative evaluations
• [ ] Summative evaluation (validation)
• [ ] Use-related risk analysis

6.2 Specific Cases

Drug/Device Combinations (6.2.1)

• [ ] Drug Master File (DMF) reference and Letter of Access
• [ ] Competent authority consultation requirements
• [ ] For EU-approved substances: all relevant documentation

Human Origin Matter (6.2.2)

• [ ] TSE/CJD risk assessment
• [ ] Source traceability and donor selection
• [ ] Processing validation for virus/agent inactivation

Animal Origin Matter (6.2.3)

• [ ] Compliance with Regulation (EU) 722/2012
• [ ] TSE risk assessment
• [ ] Source animal species and origin

Sterilisation (6.2.7)

• [ ] Applied standard and claimed SAL
• [ ] Sterilisation facility details and QMS certificate
• [ ] Sterilisation validation and revalidation (protocol and reports)
• [ ] Sterility testing (EN ISO 11737-2), bioburden testing (EN ISO 11737-1)
• [ ] Environmental monitoring and clean room validation
• [ ] ETO residuals report (if applicable, including paediatric considerations)
• [ ] Radiation dose setting/substantiation reports (if applicable)
• [ ] For end-user sterilised products: IFU validation for all claimed processes

CMR/Endocrine Disrupting Substances (6.2.6)

• [ ] Substances > 0.1% w/w identified
• [ ] Justification per GSPR 10.4.2 (exposure analysis, alternatives analysis, substitution rationale)
• [ ] Labelling of substances > 0.1% w/w per MDR requirements

Key Regulatory References

• MDR (EU) 2017/745, Annex II, Section 6
• ISO 10993 series (biological evaluation)
• EN 62304: Medical device software lifecycle
• EN 62366-1: Usability engineering
• EN 60601-1: Medical electrical equipment safety
• EN 60601-1-2: EMC
• EN ISO 11135 / 11137 / 17665: Sterilisation standards
• EN ISO 11737-1/-2: Bioburden and sterility testing
• MDCG 2019-16: Cybersecurity
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 6

Dependency

V&V is a Phase 2 deliverable. Testing is performed after device design freeze and provides the evidence base for GSPR compliance (Phase 4) and feeds into the CER benefit-risk analysis (Phase 3).