Technical Documentation: Annex II and Annex III

1. Key takeaways

Technical documentation is the centrepiece of conformity in Turkey: it is not a courtesy deliverable but a statutory obligation whose scope, granularity and retention are fixed by the Regulation itself. This article sets out the core duties, the special regime for custom-made devices, and the retention arithmetic that determines when a documentation set may finally be retired. Because the duty attaches to the manufacturer and runs for years after the last unit ships, documentation planning is a lifecycle decision rather than a project-phase task. The four points below compress the statutory frame into its operational consequences.

• Technical documentation is a statutorily mandatory deliverable in Turkey. Under paragraph 4 of Madde 10, manufacturers of devices other than custom-made devices must draw up and keep updated technical documentation covering the matters set out in Ek II and Ek III, and it must be at a level of detail sufficient to allow the conformity of the device to be assessed on its basis.
• Custom-made devices have a separate regime: paragraph 5 of Madde 10 requires their documentation to be drawn up and updated in accordance with point 2 of Ek XIII, and to be submitted to the Kurum on request.
• The retention period is a hard number: paragraph 8 point (a) of Madde 10 requires the technical documentation, the declaration of conformity and any certificates (including revisions and supplements) to be kept for at least 10 years after the last device has been placed on the market; for implantable devices it is at least 15 years.
• Retention must remain retrievable throughout: point (b) of the same paragraph 8 requires the manufacturer to submit the complete technical documentation or a summary of it, in the designated manner, whenever the Kurum so requests.

2. Legal basis

The obligations summarised above rest on two parallel regulations: the Medical Device Regulation, which supplies the detailed architecture for MD documentation, and the IVD Regulation, whose corresponding provisions impose equivalent duties on in vitro diagnostic manufacturers. The table places each instrument beside its official reference and the provisions relied on.

3. Expert insights

Insight one: a level of detail sufficient to allow assessment of conformity is a testable standard. The wording of paragraph 4 of Madde 10 is not draw up technical documentation but draw up documentation that allows the conformity of the device with the requirements of the Regulation to be assessed on its basis. This means the granularity of the file is itself a challengeable object: if a test record states only a conclusion without the method and the acceptance criteria, it cannot support an assessment of conformity. Reviewers will ask, entry by entry, whether the evidence could actually be used to reach the stated verdict — and a file that cannot answer that question fails no matter how thick it is. In practice this means that every claim in the file should be traceable to a method, a criterion and a record, and reviewers will test exactly that chain when they sample an entry.

Insight two: the 10-year and 15-year periods run from the last device placed on the market, not from the date the certificate was signed. This start point is frequently miscalculated. For discontinued products, enterprises are prone to assuming that the documentation may be cleared together with the product line; in reality a retention obligation of 10 years (15 years for implantables) remains running from the date the last unit was placed on the market. A documentation retirement policy that ignores this clock quietly accumulates violations for every product that has been phased out. The safest treatment is to record the start point explicitly in the ERP at the moment the last unit ships, so the clock is never reconstructed from memory.

Insight three: the division of labour between Ek II and Ek III determines the file structure. They respectively correspond to the descriptive information about the device and the body of the technical documentation. Building the table of contents directly on the two annexes as a two-layer skeleton makes review easier than organising it by the clause structure of ISO 13485 — because the reviewer verifies by ticking off the annex entries one by one. A structure that mirrors the reviewer’s own checklist minimises friction and removes the most common source of clarification requests. A dual skeleton — annexes for the reviewer, quality-system clauses for the internal audit — satisfies both audiences without duplicating the underlying documents.

4. Practical recommendations

• Build a two-layer table of contents skeleton on Ek II plus Ek III, with each entry mapped to an openable file and a named owner.
• Create a date of last unit placed on the market field and include it in the ERP, using it to drive expiry clean-up reminders at 10 years / 15 years.
• Keep a summary version of the technical documentation ready for a possible Kurum retrieval request, so it never has to be assembled under time pressure.

5. Verification checklist

• □ The technical documentation has been organised into a two-layer table of contents according to Ek II and Ek III.
• □ The granularity of the file meets the standard of allowing conformity to be assessed (including methods and acceptance criteria).
• □ Custom-made devices have been documented separately under point 2 of Ek XIII.
• □ Retention is executed at 10 years / 15 years for implantables, counted from the last unit placed on the market.
• □ A summary version of the technical documentation is ready for submission if the Kurum so requests.

Regulatory information verified to 29 October 2026. The provisions and retention periods listed in this article were checked against the current text on the Turkish legislative information system (MevzuatNo 38657).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team prepares CE/UTS-compliant documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com