Technical Documentation Checklist (Annex II & III)

Section 1: Device description and specificationVariants, accessories, UDI, intended use, principles of operation. Section 2: Information to be supplied by the manufacturerLabelling, packaging, and Instructions for Use (IFU). Section 3: Design and manufacturing informationDesign stages, manufacturing processes, sites, and flowcharts. Section 4: General safety and performance requirementsGSPR checklist (Annex I), standards applied, and evidence of compliance. Section 5: Benefit-risk analysis and risk managementRisk management plan, report, and analysis per ISO 14971. Section 6: Product verification and validationPre-clinical and clinical data, software validation, biocompatibility. Section 7: Post-market surveillance planContinuous monitoring process as per Article 84. Section 8: Periodic Safety Update Report (PSUR)Reference to PSUR or PMS report (Article 85/86). Section 9: SSCP (Class III / Implantable only)Summary of safety and clinical performance.

Ready for submission?

Alvento's agents can pre-audit your Technical File against Annex II/III requirements to ensure zero-deficiency submissions.

Get a pre-audit