EU MDR · Medium · 12 min lesson
Structure of the MDR technical file - Annex II, Annex III and how notified bodies expect it laid out
Regulation (EU) 2017/745 Article 10(4), Annex II, Annex III, Article 27; Team-NB best practice guidance on technical documentation
What you will learn
- Explain what MDR Article 10(4), Annex II and Annex III require the technical documentation to contain and keep up to date.
- Describe the six sections of Annex II, the Annex III post-market part, and how UDI, GSPR, benefit-risk, verification and clinical evaluation connect.
- Lay out a file the way notified bodies expect it and spot an index that hides gaps or contradictions.
Key takeaways
- Article 10(4) obliges the manufacturer to draw up and keep up to date technical documentation containing the elements of Annex II and Annex III.
- Annex II has six sections: description and specification, information supplied, design and manufacturing, GSPR, benefit-risk and risk management, verification and validation including clinical evaluation.
- Annex III adds the post-market surveillance plan and the PSUR or PMS report, so the file lives on after certification.
- Intended purpose, device name, Basic UDI-DI and variants must read identically in every document of the file.
- Team-NB guidance, version 4 of 21 April 2026, follows the Annex order and asks for a file that is a connected system, not a pile of reports.
Free practice question
Corvane's Halcyon index lists a PMS report for a class IIa device. The notified body asks where the periodic safety update report is. The quality manager says class IIa files need only a simple PMS report.
What does the MDR require for class IIa?
A PSUR under Article 86, because class IIa devices need a periodic safety update report, not only a PMS report.
Correct. Article 86 applies to classes IIa, IIb and III, while the Article 85 PMS report is for class I devices.
A PMS report under Article 85 is enough for class IIa devices.
Not quite. Article 85 covers class I devices; class IIa falls under the periodic safety update report of Article 86.
No post-market document, as class IIa is low risk.
Not quite. Annex III requires post-market documentation for all non-custom devices, and Article 84 requires a plan.
Only a complaints log kept by sales.
Not quite. A log alone does not meet the plan and report content required by Article 84 and Annex III.
Key terms
- technical documentation: The structured set of documents required by MDR Annex II and Annex III that lets conformity of a device be assessed (Article 10(4)).
- GSPR: The general safety and performance requirements of MDR Annex I, which the file must show are met or not applicable.
- Basic UDI-DI: The main access key to device information in the UDI database and in the file; it must be the same everywhere (Article 27, Annex VI Part C).
- intended purpose: The use for which a device is intended according to the manufacturer's data on label, instructions and promotional material (Article 2).
- PSUR: Periodic safety update report required for class IIa, IIb and III devices (Article 86); a PMS report serves class I (Article 85).
- generic device group: A set of devices with the same or similar intended purposes or technology, used by notified bodies when sampling technical documentation (Article 2).
Official sources
- Regulation (EU) 2017/745 (MDR), consolidated text on EUR-Lex
- Team-NB Best Practice Guidance for the submission of technical documentation under MDR Annexes II and III, version 4 (21 April 2026)
- DQS: practical lessons from the Team-NB technical documentation guidance revision
- MDCG endorsed documents and other guidance (European Commission)
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.