Overview (Annex II & III)
MDR 2017/745, Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance). Equivalent provisions in IVDR 2017/746, Annex II and III. Technical documentation must be compiled before CE marking and maintained throughout the device lifecycle.
Device description & specification
MDR Annex II, Section 1 and IVDR Annex II, Section 1. The device description and specification is the foundational section of technical documentation — it defines what the device is, what it does, and for whom.
Design & manufacturing information
MDR Annex II, Section 3 and IVDR Annex II, Section 3. This section of the technical documentation covers how the device was designed and how it is manufactured — the information necessary to ensure reproducibility and traceability.
GSPR cross-reference
MDR Annex II, Section 4 and IVDR Annex II, Section 4. The GSPR cross-reference table is a mandatory component of technical documentation linking each applicable general safety and performance requirement to the evidence of conformity.
Risk management (ISO 14971)
Risk management is required by GSPR §1 and §2 of MDR Annex I and IVDR Annex I. The harmonised standard EN ISO 14971:2019 provides the implementation framework and creates a presumption of conformity with the relevant GSPR when applied.
Post-market data in Tech Doc
MDR Annex III and IVDR Annex III define the post-market technical documentation requirements. Key documents are the PMS plan, PMS report / PSUR, and PMCF plan and evaluation report (MDR) or PMPF plan and evaluation report (IVDR).