EU MDR · Expert · 13 min lesson
Capstone part 1: review of a fictional technical file and evidence map
Regulation (EU) 2017/745 Annex II, Annex III, Annex I and Articles 8, 10 and 61, applied to a fictional Class IIb file
What you will learn
- Describe the structure of technical documentation under Annex II and Annex III and how a reviewer samples it.
- Build an evidence map that traces each general safety and performance requirement to a controlled, current record.
- Spot gaps in risk management, verification and validation and clinical links, and compare weak and compliant records.
Key takeaways
- Annex II defines six sections of technical documentation and Annex III adds post-market surveillance documents; both must be kept up to date (Article 10).
- A reviewer builds an evidence map: every claim must resolve to an approved, current, controlled record.
- Annex II section 4 requires applicability, method, standards and exact document identity for each general safety and performance requirement.
- Tested items and software versions must match the released design, and residual risks must reach the user information.
- Follow threads from hazard to control to test to label; sample deeper where a thread breaks.
Free practice question
Norvik's GSPR table lists for requirement 10.1: Complies, see biocompatibility. No report number, revision or standard is given. The regulatory manager says the reviewer can find the report in the shared drive.
What does Annex II section 4 expect in this row?
Nothing more, because a shared drive reference is enough.
Not quite. Annex II section 4 requires the precise identity of controlled documents, which a drive location does not provide.
The method, standard applied and the exact identity of the controlled evidence document.
Correct. Annex II section 4 asks for solutions adopted, method, standards and the precise identity of the controlled documents.
Only a signature of the regulatory manager.
Not quite. A signature does not identify the evidence; Annex II section 4 asks for the documents themselves to be identified.
A statement from the supplier of the material.
Not quite. A supplier statement alone is not the manufacturer's controlled evidence required by Annex II section 4.
Key terms
- technical documentation: The documents required by Annexes II and III of Regulation 2017/745 to show conformity of a device.
- evidence map: A reviewer's table tracing each requirement to the controlled record that supports it.
- GSPR: The general safety and performance requirements of Annex I of Regulation 2017/745.
- harmonised standard: A standard whose application gives a presumption of conformity with the covered requirements (Article 8).
- residual risk: The risk remaining after risk control measures, which must be communicated where relevant (Annex I).
- intended purpose: The use for which a device is intended by the manufacturer, as stated in labelling and instructions (Article 2).
- PMCF: Post-market clinical follow-up: continuous collection of clinical data on a marketed device (Annex XIV Part B).
- Annex III: Annex listing the technical documentation on post-market surveillance.
Official sources
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- EU MDR Article 56 certificates of conformity (Advisera summary)
- ISO 14971:2019 Medical devices - Application of risk management
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.