MDR Technical Documentation under Annex II: Composition, Searchability and Retention

Technical documentation is the central evidence file of the EU Medical Device Regulation. This article explains what Regulation (EU) 2017/745 requires manufacturers to compile, how notified bodies read the file in practice, and which update and retention duties shape its lifecycle.

1. Key takeaways

MDR Annex II defines the composition of technical documentation. It covers six parts: description and specification of the device, information to be supplied by the manufacturer, design and manufacturing information, demonstration of conformity with the general safety and performance requirements (GSPR), benefit-risk analysis and risk management, and verification and validation. Annex II expressly requires that the documentation be presented in a clear, organised, readily searchable and unambiguous manner.

That formulation carries legal weight, not merely editorial weight. In the context of the device-by-device assessment under Article 56 and the sampling-based review performed by notified bodies, assessors trace the verification evidence behind each applicable GSPR clause. Poor searchability translates directly into additional review rounds and additional questions. A practical estimate of good practice is to build an index line for every applicable GSPR clause, recording the clause number, applicability, justification basis, evidence file number and version date.

Technical documentation is also a living file rather than a one-off submission package. Article 10(4) obliges manufacturers to draw up and keep up to date the documentation, and Article 10(8) requires it to be retained for at least 10 years after the last device has been placed on the market, and at least 15 years for implantable devices. Post-market surveillance data, PSUR conclusions, vigilance events and design changes all trigger updates in the reverse direction. Annex III stands alongside Annex II as a separate set of post-market surveillance technical documentation, and under Article 86(1) the PSUR must form part of both the Annex II and Annex III technical documentation, except for custom-made devices.

2. Legal basis

The table below summarises the provisions and instruments cited in this article, together with their dates and sources.

All entries above are taken from the consolidated texts available on EUR-Lex, and the harmonised reading of Annex II and Annex III should always be checked against the latest consolidated version before a submission is finalised.

3. Expert insights

Insight one: readily searchable is a legal requirement, not a formatting suggestion.

Annex II opens by requiring technical documentation to be clear, organised, readily searchable and unambiguous. Under the device-by-device assessment in Article 56 and the notified body sampling review, assessors trace each applicable GSPR clause to its verification evidence one by one. Insufficient searchability directly converts into additional assessment rounds. The practical approach is to maintain, for each applicable GSPR clause, an index line covering the clause, whether it applies, the justification, the evidence file number and the version date, so that an assessor can reach any piece of evidence in one step.

Insight two: the classification justification is a mandatory item inside the documentation.

Under Section 1.1 of Annex II, the technical documentation must contain the description and specification of the device, including the justification for the classification (risk class and applicable rules). The classification outcome and the reasoning behind it must therefore live inside the documentation itself; a conclusion that exists only in commercial correspondence or internal e-mails does not satisfy the requirement. The reasoning should walk through the applicable classification rules and record why the most stringent applicable rule governs the final class.

Insight three: technical documentation is a living file, not a one-off submission document.

Article 10(4) requires manufacturers to draw up and keep up to date the technical documentation; Article 10(8) requires retention for at least 10 years after the last device has been placed on the market, and at least 15 years for implantable devices. Post-market surveillance data, PSUR conclusions, vigilance events and changes to the device or its manufacturing all feed back into updates of the file. A documentation set frozen at the date of certification will drift away from the device actually on the market, and that gap becomes visible in every subsequent surveillance audit.

Insight four: Annex III is a separate set of post-market surveillance technical documentation.

Annex III defines the content of the post-market surveillance technical documentation, including the post-market surveillance plan and reports and the PSUR. Annex II and Annex III are two parallel technical documentation sets, not one merged file. Under Article 86(1), the PSUR must form part of the Annex II and Annex III technical documentation for all devices other than custom-made devices, which means the two sets must be cross-referenced and kept mutually consistent.

4. Practical recommendations

1. Build the table of contents skeleton around the six parts of Annex II, and assign a responsible role and an update frequency to each part so that ownership is unambiguous.
2. Create a GSPR index table (clause, applicability, justification, evidence file number, version) and place it at the front of the documentation as the navigation layer for assessors.
3. Draft the classification justification as a standalone chapter, recording the application of each classification rule and the conclusion drawn under the most stringent applicable rule.
4. Write the mechanism by which change management triggers technical documentation updates into the quality management system procedures, so updates are systematic rather than discretionary.
5. Configure the document management system with retention policies for both the 10-year and 15-year tracks, starting from the day the last device is placed on the market.

5. Verification checklist

• □ The technical documentation table of contents covers the six parts of Annex II
• □ A GSPR index table has been created and points clause by clause to evidence files
• □ The classification justification stands as its own chapter and covers the application of all 22 classification rules
• □ The update mechanism for technical documentation is written into the quality management system procedures
• □ Retention policies are configured for the 10-year and 15-year tracks
• □ The Annex III post-market surveillance technical documentation has been established separately

Regulatory information verified as of 2026-10-29.

GRZAN supports medical device manufacturers entering and maintaining the EU market under Regulation (EU) 2017/745. Our team assists with the structuring and maintenance of technical documentation under Annex II and Annex III, the preparation of GSPR compliance matrices, notified body review preparation and post-market documentation updates. For technical file and conformity support for the EU MDR market, contact info@grzanglobal.com.