Intended purpose
Inconsistent wording between IFU, labels, clinical evaluation and risk file.
MDR Annexes II and III
The technical documentation is the evidence that a device meets the MDR. Annex II sets out its structure; Annex III covers post-market surveillance. A complete, well-indexed file is the single biggest factor in Notified Body review time.
| Section | Content |
|---|---|
| 1. Device description and specification | Intended purpose, users, principles of operation, risk class and classification rule, Basic UDI-DI, variants and accessories, previous and similar generations |
| 2. Information supplied by the manufacturer | Labels and instructions for use in the languages of the Member States where the device is sold |
| 3. Design and manufacturing information | Design stages, manufacturing processes and their validation, sites including suppliers and subcontractors |
| 4. General safety and performance requirements | GSPR checklist with the method used to demonstrate conformity, standards and common specifications applied, and references to evidence |
| 5. Benefit-risk analysis and risk management | Benefit-risk analysis and the risk management solutions adopted (Annex I, Sections 1 and 8) |
| 6. Product verification and validation | Pre-clinical and clinical data - bench testing, biocompatibility, software verification and validation, clinical evaluation report and PMCF plan |
The post-market surveillance plan (Article 84) and, depending on class, the PMS report or the periodic safety update report are part of the technical documentation. See post-market surveillance, PSUR and PMCF.
Inconsistent wording between IFU, labels, clinical evaluation and risk file.
Requirements marked "not applicable" without justification.
Equivalence claims that do not meet MDR Article 61 and Annex XIV.
No clear link between risks, design inputs, tests and IFU warnings.
The structure of the technical documentation: device description and specification, information supplied by the manufacturer, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management, and product verification and validation.
Technical documentation on post-market surveillance: the PMS plan and the PMS report or PSUR.
Yes. All classes need technical documentation under Annexes II and III; for Class I devices it supports the manufacturer's own declaration of conformity.
Annex III and Articles 83-86.
CER strategy.
Practical steps.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Check the consolidated text on EUR-Lex and the relevant MDCG guidance for your device. Last reviewed 30 September 2026.