Conformity Assessment Routes in Turkey: Annex IX, X and XI Procedures

1. Key takeaways

Conformity assessment is where classification turns into workload: the class assigned under Annex VIII dictates which annex procedure applies, and the choice between procedures shapes cost, sampling logic and timeline. Under the Turkish Regulation the routes mirror the European architecture closely, with two main lines available at the top class. The points below summarise the statutory anchors that every assessment plan should be checked against.

• Manufacturers must complete conformity assessment under the relevant procedure set out in Ek IX to Ek XI before placing a device on the market (Madde 52, paragraph 1); the same applies to devices not placed on the market but put into service (paragraph 2).
• Manufacturers of Class III devices (except custom-made and devices for research) must undergo the assessment described in Ek IX; they may alternatively choose the assessment shown in Ek X together with the assessment shown in Ek XI (Madde 52, paragraph 3).
• Manufacturers of Class IIb devices must proceed under Chapters I and III of Ek IX, with the technical documentation assessment performed on at least one device per generic device group (jenerik cihaz grubu) (Madde 52, paragraph 4 (a); the details follow the Turkish original text).
• Two optional main lines result: the Ek IX route (quality system plus technical documentation), and the Ek X (type examination) plus Ek XI (production quality assurance) route. The latter is expressly listed as an optional alternative on the Class III side.

2. Legal basis

The table below consolidates the instruments cited in this article. Both the device Regulation and the IVD Regulation are listed, because the assessment architecture of the IVD side is built on the same annexes, applied through Madde 50 rather than Madde 52.

3. Expert insights

Insight one: the generic device group is the key variable for cost optimisation. The technical documentation assessment under paragraph 4 (a) of Madde 52 samples by generic device group, not model by model. For Chinese enterprises with long product lines, how a group is defined directly determines the assessment workload and the fee. The definition must be documented in writing and agreed with the notified body in advance. A group drawn too narrowly multiplies assessments for products that could have been covered together; a group drawn too broadly invites the notified body to challenge the commonality, and the challenge arrives after the quotation stage, when renegotiation is hardest.

Insight two: Ek X plus Ek XI is a route that is more economical in certain situations. On the Ek X side a type examination is performed; on the Ek XI side production consistency is assured. For product lines with a relatively converged set of types but high output volume, this route can reduce repeated technical documentation sampling. Its precondition is that the type boundary must be clear: once production exceeds the type range, re-assessment is needed. The economics therefore depend on how stable the design is; a line that iterates frequently may find that the savings are consumed by re-examination events, and the trade-off should be evaluated on a horizon of several years rather than a single certification cycle. The comparison should also include the audit cadence of each route, because the surveillance burden attached to a production quality assurance system differs from that attached to type examination, and the difference lands in the annual operating budget long after the initial certificate decision has been forgotten.

Insight three: the IVD route is likewise Madde 50 plus Ek IX to XI, but the starting point differs. The wording of Madde 50 of the IVD Regulation is highly isomorphic with Madde 52 of the device Regulation, but because the classification runs from A to D, the actual assessment sampling intensity is far below the device side. A common mistake when domestic IVD products go abroad is to transplant the sampling logic of the device Regulation, resulting in a submission scope that is too wide. The over-wide scope inflates cost and invites questions about documents that were never required, so the class-to-annex mapping should be built from the IVD Regulation text directly. Teams working on both families under one programme should maintain the two mappings as separate reference sheets, cross-checked only where a product genuinely straddles both regimes, and each sheet should carry the article citation of the regime it derives from so that reviewers can trace every sampling decision back to its own legal anchor.

4. Practical recommendations

• Fix the generic device group definition document before discussing assessment routes. The definition should state the common intended purpose, the common technical features and the common risk profile.
• For Class III, calculate the total cost and total timeline of the Ek IX route and the Ek X plus Ek XI route, and count future model extensions into the calculation, so that saving current fees does not sacrifice later expansion capability.
• The first written material communicated to the notified body should be a product genealogy chart plus the generic grouping explanation, not an application form for a single model.

5. Verification checklist

• □ The applicable provision has been confirmed as Madde 52 of the device Regulation or Madde 50 of the IVD Regulation.
• □ The assessment route has been defined: Ek IX or Ek X plus Ek XI.
• □ A generic device group definition document has been issued, and the sampling basis confirmed with the notified body in writing.
• □ For Class III, the reasons for choosing Ek IX or Ek X plus Ek XI have been recorded in writing.
• □ All assessment activities have been scheduled to complete before placing on the market.

Regulatory information verified to 29 October 2026. The provisions listed in this article were checked against the original texts on the Turkish legislative information system (MevzuatNo 38657, 38658).

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 manages TITCK approval applications and UTS registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com