The technical documentation is the central document of MDR compliance. Annex II of Regulation (EU) 2017/745 defines its content. It is not an indicative list: every section is mandatory. A file that omits a section is not incomplete — it is non-compliant with the regulatory requirements.
The 6 sections of Annex II
Section 1 — Device description and specification, including variants and accessories. Product or trade name and general description, including the intended purpose and intended users; Basic UDI-DI; intended patient population, indications, contra-indications and warnings; principles of operation and mode of action; rationale for qualification as a medical device; risk class and the classification rule applied (Annex VIII); novel features; accessories, variants and configurations; key functional elements, raw materials (in particular those in contact with the body) and technical specifications. Subsection 1.2 requires a reference to previous generations and similar devices.
Section 2 — Information to be supplied by the manufacturer. A complete set of the labels on the device and its packaging, and the instructions for use in the languages accepted in the Member States where the device is intended to be sold (requirements of Annex I, Section 23).
Section 3 — Design and manufacturing information. Information allowing the design stages to be understood; complete information and specifications on the manufacturing processes and their validation, adjuvants, continuous monitoring and final product testing; identification of all design and manufacturing sites, including suppliers and sub-contractors.
Section 4 — General safety and performance requirements. Demonstration of conformity with the applicable Annex I requirements and justification for those that do not apply; the methods used; harmonised standards, common specifications or other solutions applied; precise identification of the controlled documents providing evidence of conformity.
Section 5 — Benefit-risk analysis and risk management. The benefit-risk analysis (Annex I, Sections 1 and 8), the solutions adopted and the results of risk management (Annex I, Section 3), based on the risk management file established in accordance with ISO 14971.
Section 6 — Product verification and validation. Subsection 6.1: results of tests (engineering, laboratory, simulated use, animal tests) and evaluation of published literature, in particular biocompatibility, physical, chemical and microbiological characterisation, electrical safety and electromagnetic compatibility, software verification and validation, stability and shelf life, performance and safety; the clinical evaluation report and its updates, and the clinical evaluation plan; the PMCF plan and PMCF evaluation report, or a justification of why they do not apply. Subsection 6.2: additional information in specific cases (medicinal substance, tissues or cells of human or animal origin, substances absorbed or locally dispersed, CMR or endocrine-disrupting substances, devices in sterile or defined microbiological condition, measuring function, devices intended to be connected to other devices).
What does not belong to Annex II
Several documents often presented as “sections” of Annex II actually fall under other provisions:
- The summary of safety and clinical performance (SSCP): Article 32, for implantable devices and class III devices, other than custom-made or investigational devices.
- The post-market surveillance plan, the PMS report and the PSUR: technical documentation on post-market surveillance, Annex III (Articles 84 to 86).
- UDI and device registration in EUDAMED: Articles 27 and 29; Annex II only requires the Basic UDI-DI, in Section 1.
These documents remain mandatory and linked to the technical documentation, but presenting them as sections of Annex II distorts the structure of the file.
What notified bodies examine first
Sections 4, 5 and 6 account for most of the exchanges with notified bodies: they are the ones requiring the most substantive 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