Technical Documentation: Annex II, Annex III and Retention
Technical documentation is the object of the assessment. The exam tests whether you know what Annex II actually requires, how Annex III differs, and how long the file must survive.
Annex II: six sections
Section 1 covers device description and specification, including variants, accessories, previous and similar generations and the basic UDI-DI. Section 2 covers information supplied by the manufacturer: labels, instructions for use and language versions. Section 3 covers design and manufacturing information: drawings, software description, manufacturing processes and, where relevant, the supplier and subcontractor chain. Section 4 is the general safety and performance requirements checklist, justifying conformity or non-applicability for every requirement in Annex I. Section 5 covers benefit-risk analysis and risk management, referencing the ISO 14971 file. Section 6 covers product verification and validation: pre-clinical and clinical data, biocompatibility, electrical safety, software verification, stability and sterility.
Annex III: post-market technical documentation
Annex III is separate and often forgotten. It contains the post-market surveillance plan, the PMCF plan or, for IVDs, the post-market performance follow-up plan, and the corresponding evaluation reports.
Retention and language
Article 10(8) requires the manufacturer to keep the technical documentation available to competent authorities for at least 10 years after the last device is placed on the market, extended to 15 years for implantable devices. Documentation must be supplied in an official Union language accepted by the notified body, and the notified body defines which.
Worked example
A file presents a GSPR table in which 14 requirements are marked not applicable without rationale. The assessment fails at Annex II section 4: non-applicability must be justified against the intended purpose, and each justification must be traceable to the device description in section 1 and the labelling in section 2.
Traps
Submitting promotional material instead of section 2 content; treating the risk management file as detached from Annex II section 5; forgetting Annex III when a PSUR is requested; and starting the retention clock at certificate expiry rather than at the last placing on the market.