Technical documentation is the evidence package that shows a device meets the IVDR. Notified bodies review it in depth for Class B, C and D devices, and authorities can request it at any time.
What Annex II requires
- Device description and specification: intended purpose, users, principles of the method, components, variants, previous generations and similar devices
- Information supplied by the manufacturer: labels and instructions for use in the languages of the target markets
- Design and manufacturing information: design stages, manufacturing processes and sites, including key suppliers
- General safety and performance requirements: a checklist showing how each Annex I requirement is met, the standards and common specifications applied, and where the evidence sits
- Benefit-risk analysis and risk management
- Product verification and validation: analytical and clinical performance, stability, software verification and validation, and performance evaluation reports
Annex III adds the post-market surveillance documentation: the PMS plan, PMPF plan and the resulting reports.
Tips for a strong file
- Structure the file exactly as Annex II is structured so reviewers can navigate it
- Use the GSPR checklist as the map to every piece of evidence
- Keep a single, consistent intended purpose statement across labeling, risk, performance and marketing material
- Include clear rationales, not just test reports
- Control versions carefully; mismatched document versions are a frequent finding
- Plan translations of labeling early
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.