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.
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.
Both MDR 2017/745 and IVDR 2017/746. The GSPR checklist (cross-reference table) is a mandatory component of the technical documentation under Annex II of both regulations.
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.
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).
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.
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.