Transition Preconditions: QMS Establishment, Application and Agreement Deadlines

1. Key takeaways

The transition extension described in the preceding article is not available to everyone: it is gated by three preconditions with fixed dates, and by the verification date of this article all three have already passed. For project planning this changes the strategic answer: the extension is a matter for auditing legacy files, not for new applications. The points below state the preconditions, their dates and the consequence for current projects.

• The extended period described in article 18 of this series is not universal. It carries three preconditions (paragraph 5 of Geçici Madde 1): the quality management system was established before 26 May 2024; the formal application submitted by the manufacturer or its authorised representative to the notified body was completed before 26 May 2024; and the written agreement with the notified body was signed before 24 September 2024.
• Measured against this verification date (29 October 2026), all three time anchors have already passed. Projects that have not completed the above actions can no longer invoke the extended period.
• Paragraph 5 of Geçici Madde 1 further provides that the notified body which signed the written agreement bears responsibility for surveillance of the devices covered by the agreement at the latest until 24 September 2024. This is an easily overlooked node of transfer of surveillance responsibility.
• From this flows a practical judgement: new projects should obtain certification directly under the new Regulation (MDR/IVDR system), rather than relying on the extended-period window.

2. Legal basis

The table below consolidates the instruments cited in this article. The amending Regulation is listed because its revision marking on the transitional provision is what confirms the current wording of the three preconditions.

3. Expert insights

Insight one: the extended period addresses projects already on the rails, not future new projects. The common feature of the three preconditions is that they require the manufacturer to have started the formal procedure with a notified body before 26 May 2024. The design intent is clear: the extension was carved out to give legacy projects already in the queue breathing room, not to open a new window for latecomers. Treating the extension as a general relaxation of the timetable leads planners to schedule around dates that, for their projects, never applied at all, and the error typically surfaces when the notified body asks for evidence of the preconditions during intake. Building the three-evidence check into the intake preparation of every legacy file, once, converts an unpredictable discovery risk into a fixed administrative step whose outcome is known before any application is refreshed.

Insight two: the formal application and the written agreement are two verifiable actions, and the interval between them was only about 4 months. From 2024-05-26 to 2024-09-24, manufacturers had roughly 4 months to move from submission of the application to signature of the agreement. That rhythm demanded sufficient lead time in QMS establishment, document submission and the commercial process with the notified body. The shortness of the interval explains why the population of projects actually eligible for the extension is small: only operations that were already running a full assessment programme could compress both steps into that span.

Insight three: surveillance responsibility completed its transfer after 2024-09-24. For projects invoking the extension, the surveillance responsibility of the original notified body ends on that date; thereafter the attribution of responsibility must return to the new contractual arrangement or the new certificate system. If an enterprise has not switched the surveillance subject in step during this period, a surveillance vacuum arises, which is the pitfall that users of the extended period most frequently fall into. A vacuum of this kind is rarely detected until the next audit or a vigilance event, because day-to-day operations look unchanged while the contractual coverage underneath has lapsed. The practical safeguard is procedural: make the surveillance confirmation a standing item in the periodic regulatory review, so that the question of who covers surveillance is answered on a schedule rather than in a crisis.

4. Practical recommendations

• Run a two-bucket scan of legacy projects: those satisfying the three preconditions are managed under the extended period; those not satisfying them are switched immediately to a schedule of certification under the new Regulation.
• For every product invoking the extension, verify the three pieces of evidence one by one: proof of quality system establishment, the receipt of formal application submission, and the signature page of the written agreement. Missing any one means handling under the new system. Project teams handling such files should also archive the internal decision trail: the note explaining why the extension applies, signed by the responsible person, becomes the anchor for any later question about why the project took the transition route, and it costs one paragraph to create while the reasoning is still fresh.
• Check whether the surveillance arrangement after 2024-09-24 is in place: who is responsible for surveillance, and in which document the contractual basis lies.

5. Verification checklist

• □ The date of the QMS establishment evidence has been confirmed as earlier than 2024-05-26.
• □ The receipt of formal application submission to the notified body has been obtained, dated earlier than 2024-05-26.
• □ The signature page of the written agreement has been obtained, dated earlier than 2024-09-24.
• □ The surveillance responsibility holder and contractual basis after 2024-09-24 have been confirmed.
• □ Products for which any of the above is incomplete have exited extended-period management and moved to scheduling under the new system.

Regulatory information verified to 29 October 2026. The dates and preconditions in this article were checked against the current text on the Turkish legislative information system (MevzuatNo 38657); this verification date is later than all three time anchors.

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