EU MDR · Expert · 13 min lesson
Technical documentation per MDR Annexes II and III: structure, GSPR checklist and common deficiencies
Regulation (EU) 2017/745 Article 10(4), Annexes I, II and III; Team-NB best practice guidance on technical documentation
What you will learn
- Describe the structure of the technical documentation under MDR Annexes II and III and what each section must contain.
- Build and read a GSPR checklist that links every Annex I requirement to a method, a standard and a precise piece of evidence.
- Recognise the deficiencies notified bodies raise most often and correct them before the file is submitted.
Key takeaways
- Article 10(4) obliges the manufacturer to draw up and keep technical documentation up to date; Annexes II and III define its content.
- Annex II follows six sections: description, information supplied, design and manufacturing, GSPR, risk and benefit-risk, verification and validation.
- Every Annex I requirement gets a row: applicability and reason, method, standard edition, extent of compliance and a precise evidence reference.
- Annex III requires a post market surveillance plan for all devices and a periodic safety update report for classes IIa, IIb and III.
- Most deficiencies concern navigation, inconsistency (for example the Basic UDI-DI) and missing justification, and a pre submission review prevents them.
Free practice question
Halden's technical file has a folder structure invented by the project manager: Marketing, Engineering, Quality, Misc. The reviewer must search all four folders to find the risk file, and the GSPR checklist is in Misc.
What is the strongest correction against Annex II?
Keep the structure; add a note to the cover letter.
Not quite. The Annex II preamble requires a clear, organised, searchable file, and a cover letter does not fix the structure.
Reorganise the file to follow the six Annex II sections, with a hyperlinked index.
Correct. The Annex II preamble requires an organised, searchable presentation, and following the six sections is the simplest way to achieve it.
Delete the Misc folder and keep everything else.
Not quite. Deleting a folder removes content without creating the Annex II order the reviewer expects.
Submit only the folder the reviewer asks for.
Not quite. The manufacturer must provide complete documentation under Article 10(4), not a selection.
Key terms
- technical documentation: The file defined by MDR Annexes II and III that demonstrates conformity of a device.
- GSPR: General safety and performance requirements listed in MDR Annex I, chapters I to III.
- Basic UDI-DI: The primary identifier of a device model, which must be the same in every document and record.
- PSUR: Periodic report of post market data and conclusions required for classes IIa, IIb and III.
- PMS plan: Annex III plan describing data sources, methods, indicators and thresholds for post market surveillance.
- traceability: The link from each requirement and risk control to its verification evidence.
- harmonised standard: A standard whose application gives a presumption of conformity with the related requirement.
- notified body: Independent conformity assessment body designated under the MDR.
Official sources
- Regulation (EU) 2017/745 on medical devices (consolidated text, EUR-Lex)
- Team-NB Position Paper: Best Practice Guidance for the Submission of Technical Documentation under MDR (Annexes II and III), version 4
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.