What MDR technical documentation is
Under the EU Medical Device Regulation, every manufacturer must “draw up and keep up to date technical documentation” for its devices (Article 10(4)) (EUR-Lex). Often called the technical file, it is the evidence that a device meets the MDR’s general safety and performance requirements (GSPRs). Notified bodies review it during conformity assessment, and competent authorities can request it at any time.
The MDR sets out the content in two annexes. Annex II covers the device and its conformity; Annex III covers post-market surveillance. Annex II also sets the tone: documentation “shall be presented in a clear, organised, readily searchable and unambiguous manner” (MDR Annex II, via Advisera).
For a submission-ready checklist covering Annex II, Annex III and the GSPR matrix, see EU MDR Technical Documentation Checklist: Annex II, Annex III and the GSPR Matrix. For how to review a technical file before FDA or a notified body does, see Medical Device Technical Documentation Review: How to Review a Technical File Before FDA or a Notified Body Does.
Annex II: the technical documentation
| Section | Main contents |
|---|---|
| 1. Device description and specification, including variants and accessories | Intended purpose, users, principles of operation, classification and rule, UDI-DI, variants, previous generations and similar devices |
| 2. Information to be supplied by the manufacturer | Labels, instructions for use, in the languages of the target member states |
| 3. Design and manufacturing information | Design stages, manufacturing processes and validation, sites and critical suppliers |
| 4. General safety and performance requirements | GSPR checklist: applicability, method of conformity, standards and common specifications, and references to evidence |
| 5. Benefit-risk analysis and risk management | Benefit-risk determination and the risk management file |
| 6. Product verification and validation | Pre-clinical and clinical data, including the clinical evaluation report, plus specific items such as biocompatibility, software, sterilization, and medicinal or animal-tissue components where relevant |
Section headings per MDR Annex II, via Advisera.
Annex III: post-market surveillance documentation
Annex III requires documentation of the post-market surveillance system. Team-NB’s guidance structures it as a PMS plan and, for class IIa, IIb and III devices, the periodic safety update report (PSUR) (Team-NB). Class I devices produce a PMS report instead. The PMS plan must explain how data will be collected and used to update the benefit-risk analysis, clinical evaluation and risk management.
The GSPR checklist: the backbone of the file
The GSPR checklist links each requirement in Annex I to the evidence that the device meets it. Notified body SGS asks for “GSPR compliance rationales (e.g. GSPR matrix),” says “links / references to supporting evidence must be as specific as possible,” and notes that the technical documentation “shall document how the manufacturer ensures compliance with every applicable GSPR” (SGS).
A strong checklist does three things: justifies why any requirement is not applicable, names the standard or method used, and points to the exact report and section where evidence lives.
Clinical evidence
Clinical evaluation is usually the most scrutinized part of the file. MDCG guidance documents set expectations, including MDCG 2020-5 on equivalence, MDCG 2020-13 (the clinical evaluation assessment report template notified bodies use) and MDCG 2023-7 on exemptions from clinical investigations (European Commission MDCG guidance). Writing the clinical evaluation report with the CEAR template in mind helps reviewers find what they need.
What notified bodies flag most often
In its April 2026 best-practice guidance, Team-NB states that “The most common reasons for delays in Technical Documentation assessments by notified bodies are” (Team-NB):
- “Insufficient or missing information”
- “Lack of Cohesive Structure of Technical Documentation”
- “Inconsistent language within the Technical Documentation”
The same guidance warns that “Abbreviated or partial test reports are not considered acceptable” and “Scanned documents are to be avoided.” Notified body DQS adds that submissions often contain “Insufficient, inconsistent or missing information necessary for complete conformity assessment activities,” and that “The submission scope is too broad for a single conformity assessment” (DQS).
The pattern: most delays come from documents that do not connect, not from missing tests. The intended purpose stated in the IFU differs from the one in the clinical evaluation; a risk control in the risk file has no verification evidence; a GSPR reference points to the wrong report revision.
How to build a review-ready technical file
- Fix the intended purpose first and use the exact wording everywhere.
- Follow the Annex II order, or provide a clear cross-reference map if your structure differs.
- Build the GSPR checklist with precise references to report numbers, revisions and sections.
- Connect risk, verification and clinical data. Every risk control should trace to verification evidence, and residual risks to the benefit-risk conclusion.
- Provide complete, searchable reports, not summaries or scans.
- Align labeling and IFU with the risk file and clinical evaluation.
- Complete Annex III with a PMS plan that feeds updates back into the file.
- Run a consistency review across the whole file before submission.
Technical documentation checklist
- Intended purpose identical across description, IFU, risk file and clinical evaluation
- Classification and rule rationale documented
- Labels and IFU complete for target languages
- Design and manufacturing information, sites and critical suppliers listed
- GSPR checklist with applicability justifications and specific evidence references
- Benefit-risk analysis and risk management file complete
- Full verification and validation reports included, searchable and current
- Clinical evaluation report aligned with MDCG guidance
- PMS plan and PSUR or PMS report per Annex III
- Cross-document consistency review completed
Find inconsistencies before your notified body does
Consistency across hundreds of pages is hard to check by hand. AskDona assesses technical documentation against MDR Annex II and III or your GSPR checklist, flags missing content and contradictions between documents, and cites the passage behind every finding.
Run a sample technical documentation assessment on part of your technical file. AskDona shows the evidence; your regulatory team decides.
FAQ
What is MDR technical documentation? The file of evidence required by Article 10(4) and Annexes II and III to show a device meets the MDR’s GSPRs.
Is a technical file the same as technical documentation? In everyday use, yes. The MDR uses the term technical documentation.
What is in Annex II? Device description, labeling, design and manufacturing information, GSPRs, benefit-risk and risk management, and verification and validation.
What is in Annex III? Post-market surveillance documentation: the PMS plan and the PSUR or PMS report.
Why do notified body reviews take so long? The most common reasons are missing information, poor structure and inconsistent language (Team-NB).
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| EUR-Lex: Regulation (EU) 2017/745 | Regulation | May 5, 2017 | Article 10(4) |
| Advisera: MDR Annex II | Regulation text reproduction | n.d. | Annex II headings |
| Team-NB: Best practice guidance v4 | Notified body association | Apr 21, 2026 | Annex III, common delays |
| SGS: Technical documentation checklist | Notified body | 2023 | GSPR expectations |
| European Commission: MDCG guidance | Regulator | 2026 | Clinical guidance |
| DQS: Common mistakes | Notified body | Feb 21, 2025 | Common mistakes |