Supply Interruption and Discontinuation: Six-Month Advance Notice in Turkey

1. Key takeaways

The third amending regulation added a supply continuity obligation to the Turkish Medical Device Regulation in the form of Madde 10/A. Where a manufacturer foresees an interruption or discontinuation of supply that could cause serious harm to patients or public health, that foreseeable event must be notified to a defined list of recipients at least six months in advance. This article reconstructs the trigger, the recipients and the downstream transmission duty.

• Madde 10/A is a provision added by the third amending regulation: the insertion is marked (Ek:RG-17/8/2024-32635), meaning it was added by issue 32635 of the Resmî Gazete dated 17 August 2024.
• The trigger is twofold: (i) the manufacturer foresees an interruption or discontinuation of supply of its device (custom-made devices excepted); and (ii) it can reasonably be foreseen that the interruption or discontinuation will lead to serious harm or a serious risk of harm to patients or public health in Turkey or in one or more European Union member states.
• There are three categories of recipients: the Kurum, the economic operators directly supplied with the device, and health institutions and healthcare professionals (Madde 10/A paragraph 1 subparagraph (a)).
• The timing requirement is strict: except in exception circumstances, the information must be provided at least 6 months before the foreseen interruption or discontinuation; the manufacturer must also state clearly the reasons for the interruption or discontinuation in the information provided to the Kurum (paragraph 1 subparagraph (b)).
• Downstream links in the supply chain carry obligations as well: paragraph 3 requires economic operators who receive the information to communicate it without delay to the entities they directly supply and to health institutions and healthcare professionals.

2. Legal basis

The obligation rests on the base regulation and on the amending instrument that inserted the provision. The table below records both, together with the insertion marking that identifies the origin of Madde 10/A.

3. Expert insights

Insight 1: this provision turns supply continuity into a legal duty. Under a conventional commercial contract, an interruption of supply typically triggers only liability for breach. Madde 10/A elevates the same event into a reporting obligation towards the competent authority. The six-month lead time means that when a company decides to stop production, change product lines or switch a contract manufacturer, the compliance process must start half a year ahead of the ordinary commercial decision. Teams that treat discontinuation purely as a procurement matter will discover that the statutory clock began long before legal was consulted.

Insight 2: the core of the assessment is the reasonably foreseeable risk of serious harm. Not every interruption must be reported. The threshold in the text is set at serious harm or a serious risk of harm to patients or public health. This means the assessment has to revolve around whether alternatives are available and whether the device is life-sustaining or critical to treatment. Companies should build a written assessment template that fixes the reasoning for deciding whether the notification is triggered, so that each decision leaves a documented trail that can be shown to the authority or audited internally at a later date.

Insight 3: the downstream chain inherits a transmission duty. Paragraph 3 carries the notification obligation down the supply chain. For importers and distributors, failing to pass on the information received from upstream also constitutes a violation of the regulation. GRZAN recommends that distribution contracts specify the time limit for this forwarding action and the way it is evidenced, so that each link in the chain can demonstrate compliance and so that responsibility does not dissolve between commercial partners.

Insight 4: the three recipient categories serve different purposes and should not be merged into one notice. The Kurum needs the information for regulatory oversight, including the stated reasons; the economic operators directly supplied need it to plan their own inventories and their own notifications downwards; and health institutions and healthcare professionals need it to manage patient-level continuity of care. A single undifferentiated message sent to everyone at once tends to satisfy none of these audiences properly. Companies should therefore prepare one core content set and adapt the framing for each recipient category, keeping the six-month advance requirement identical across all of them.

4. Practical recommendations

• Build a supply interruption assessment form covering whether the product is life-sustaining or critical to treatment, whether alternative sources exist, and whether the scope of impact requires notification.
• Configure triggers in the ERP system for production stoppage, product line changes, contract manufacturer changes and certificate expiry, each of which automatically activates the six-month countdown.
• Specify the downstream forwarding duty and its time limit in distribution contracts, and require evidence of each forwarding action to be retained.
• Route the notification to all three recipient categories, ensuring that the reasons for the interruption are stated in the information given to the Kurum.

5. Verification checklist

• □ The origin of Madde 10/A in issue 32635 (2024-08-17) is known.
• □ Custom-made devices (outside the scope) have been distinguished from other devices.
• □ A written assessment template for serious harm or a serious risk of serious harm has been established.
• □ The notification list covers all three categories: the Kurum, directly supplied entities, health institutions and healthcare professionals.
• □ A six-month advance countdown and an evidence mechanism for downstream forwarding have been set up.

Regulatory information verified as of 29 October 2026. The text of Madde 10/A, the insertion marking and the six-month requirement cited in this article were checked against the current text on the Turkish legislation 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 adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com