The technical documentation is the central document of MDR compliance. Annex II of Regulation (EU) 2017/745 defines its content. This is not an indicative list: each section is mandatory. A file that omits a section is not incomplete — it is non-compliant with the regulatory requirements.
The 16 sections of Annex II, section by section
Section 1 — Device description and specification. Name or trade name, reference number, date of manufacture if applicable, UDI, intended purpose of the device, target patient population, indications and contraindications, principles of operation, description of all generations of the device if applicable.
Section 2 — Information supplied by the manufacturer. Label and IFU in accordance with Annex I, Section 23. All the languages of the Member States where the device is marketed.
Section 3 — Design and manufacturing information. Design characteristics (diagrams, drawings, component lists), raw materials and materials in contact with the patient or biological tissues, manufacturing processes, manufacturing sites.
Section 4 — General safety and performance requirements. List of applicable GSPR, harmonised standards applied with reference to their publication in the OJEU, common specifications where relevant, alternative solutions adopted, justifications for non-applicabilities.
Section 5 — Benefit/risk analysis and risk management. Summary of the risk analysis, control measures retained, residual risks, conclusion on the acceptability of the overall benefit/risk ratio. This summary draws on the complete risk management file according to ISO 14971.
Section 6 — Product verification and validation. Results of the verification and validation tests: biocompatibility (ISO 10993 series), sterility and sterility assurance levels (SAL), stability and shelf life, performance testing according to the intended purpose, electromagnetic assessment (for active devices), software validation (IEC 62304 for embedded software).
Section 7 — Clinical data. Clinical evaluation plan, clinical evaluation report (CER), PMCF plan and report.
Section 8 — Summary of safety and clinical performance (SSCP). Mandatory for implantable devices and class III devices. Public document via EUDAMED.
Section 9 — Labelling. Copies of the labels actually used, in all the languages of the Member States where the device is marketed.
Section 10 — Instructions for use. Copies of the complete IFU, in all the required languages.
Section 11 — Information on combination devices. If the device incorporates a medicinal product, an IVD or a tissue of human or animal origin.
Section 12 — Manufacturing procedures. Detailed description of the manufacturing processes, in-process controls, and validated special processes.
Section 13 — Results of validity studies. Where applicable.
Section 14 — Unique Device Identification system (UDI). Assignment and EUDAMED registration.
Section 15 — PMS plan. Post-market surveillance plan.
Section 16 — PMS report or PSUR. Depending on the class of the device and the stage of marketing.
What notified bodies examine as a priority
Sections 4, 5, 6 and 7 concentrate the majority of the exchanges with notified bodies. These are the sections that require the most substantial data. Section 4 (GSPR) is often the first document requested: its correspondence table immediately reveals whether the manufacturer has a complete view of the applicable requirements.
Regulatory source: Annex II of Regulation (EU) 2017/745 — EUR-Lex