Systems, Procedure Packs and Spare Parts under the Turkish Medical Device Regulation

1. Key takeaways

Assembling CE-marked devices with other equipment or products into systems or procedure packs is a legitimate commercial model in Turkey, but it generates its own statutory duties that sit on top of the approvals of the components. Whoever assembles the pack becomes the addressee of those duties, and the obligations extend beyond paper into UDI coding. The points below summarise the rules for packs and the two-tier treatment of spare parts.

• Anyone who places on the market a combination of CE-marked devices with other devices or products as a system or procedure pack (sistem veya işlem paketi) must issue a written statement, under paragraph 1 of Madde 22.
• Three categories of components may be combined (paragraph 1 of Madde 22): (a) other CE-marked devices; (b) in vitro diagnostic devices that comply with the IVD Regulation and bear CE marking; (c) other products that comply with their applicable laws, provided that their use within a medical procedure, or their presence within the system or pack, has been justified elsewhere.
• The statement duties include: verifying the mutual compatibility of the medical devices (and other products) with each other and their operation in accordance with the manufacturers’ instructions; and packaging the system or procedure pack and supplying relevant information to users, including the relevant instructions for use. These contents are in paragraph 2 of Madde 22.
• System packs carry an independent coding duty: paragraph 2 of Madde 29 requires that a system or procedure pack be assigned a Temel UDI-DI (Basic UDI-DI) and entered in the UDI database before being placed on the market.
• Spare parts are handled in two tiers (Madde 23): replacement parts that do not change the performance or safety characteristics or the intended use are placed on the market by the person placing them with an assurance that they do not adversely affect the safety and performance of the device, with evidence retained; replacement parts that significantly change any of those items are themselves regarded as devices and must satisfy all requirements of the Regulation.

2. Legal basis

The table below consolidates the instruments cited in this article. The second row records the second amending Regulation, which adjusted the wording relevant to paragraph 2 of Madde 29, the provision that requires independent coding of systems and procedure packs.

3. Expert insights

Insight one: the responsible party for a system pack is the assembler, and the form of responsibility is a statement, not a certification. Madde 22 does not require a fresh CE certification exercise, but it requires the assembler to self-certify compatibility, packaging compliance and information delivery in the form of a written statement. That statement is the first piece of evidence in any subsequent accountability chain. When Chinese enterprises bid in Turkey with a combined package of equipment, reagents and consumables, the party that carries this statement duty must be identified in advance; leaving it undefined means that no one in the chain has actually discharged the obligation when the authority or a customer asks who verified the compatibility of the combination.

Insight two: paragraph 2 of Madde 29 is an easily missed action. A system or procedure pack itself needs an independent Temel UDI-DI and an entry in the UDI database. The situation seen commonly in practice is that every component carries a code, but the assembled pack does not, which constitutes a systemic gap. The gap is invisible until a traceability exercise or a tender document review exposes it, at which point correcting it means regenerating labels, republishing database entries and reconciling stock already in the channel, so the correction cost far exceeds the cost of coding the pack correctly at the outset.

Insight three: paragraph 2 of Madde 23 is the hidden minefield of the spare parts business. An apparently routine spare part escalates from an accessory to a device as soon as it produces a significant change in performance, safety characteristics or intended use. The test is not subjective naming, whether the item is called an accessory or a device, but objective impact. That escalation means a full technical documentation set and conformity assessment become necessary. Spare part catalogues should therefore be reviewed by regulatory staff, not only by engineering, because the classification turns on effects that engineering teams may not flag as regulatory events.

4. Practical recommendations

• Identify the assembler of the system pack and its Madde 22 statement duty in bid documents and distribution agreements.
• Establish pack-level coding: generate and record a separate Temel UDI-DI for each pack in the UDI ledger.
• Run an impact matrix over the spare parts list first: three columns for performance, safety characteristics and intended use; any column marked as significantly changed means the item is managed as a device.

5. Verification checklist

• □ Whether the combination constitutes a system or procedure pack within the meaning of Madde 22 has been confirmed.
• □ A written statement has been issued by the assembler, covering compatibility verification, packaging and delivery of information to users.
• □ An independent Temel UDI-DI has been assigned to the system pack and the UDI database entry completed.
• □ Spare parts have been assessed through the impact matrix under Madde 23.
• □ The justification for including non-device products in the combination has been argued separately and retained.

Regulatory information verified to 29 October 2026. The provisions listed in this article were checked against the original 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 manages TITCK approval applications and UTS registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com