Vigilance Reporting Deadlines: 2, 10 and 15 Days in Turkey

1. Key takeaways

Serious incident reporting in Turkey runs on three deadlines, all of them located in Madde 85 of the Medical Device Regulation. This article sets out the three tiers, the supporting provisions that make timely reporting feasible, and the neighbouring obligations with which serious incident reporting is most often confused, including the cross-border duty to report field safety corrective actions performed outside Turkey and the European Union.

• The reporting deadlines for serious incidents in Turkey fall into three tiers, all set out in Madde 85:
  • Paragraph 3: for serious incidents under the general rule, no later than 15 days from the date on which the manufacturer becomes aware of the incident;
  • Paragraph 4: for incidents constituting a serious public health threat, no later than 2 days from the date of awareness;
  • Paragraph 5: where a death or an unanticipated serious deterioration in a person’s state of health has occurred, the period runs from the date on which the manufacturer establishes or suspects the causal relationship, and is no later than 10 days from the date of awareness.
• The reporting duty is supported by companion provisions: paragraph 6 allows an initial report to be submitted before the complete report in order to meet the deadline, and paragraph 7 makes arrangements for potentially reportable incidents.
• Beyond serious incidents, Madde 85 paragraph 1 subparagraph (b) also requires the reporting of field safety corrective actions (FSCA) carried out outside Turkey or the European Union, unless the reason for the action is confined to markets outside Turkey and the European Union.
• Two further obligations are frequently confused with serious incident reporting: Madde 86 concerns trend reporting, covering statistically significant increases in frequency or severity of non-serious incidents, and Madde 84 paragraph 2 concerns PSUR requirements. The corresponding IVD provisions are Madde 82—85 of the IVD Regulation, which use different numbering.

2. Legal basis

The three-tier deadline structure rests on two regulations published on the same day, one covering devices and one covering in vitro diagnostic devices. The table below records the provisions on which the analysis above is based.

3. Expert insights

Insight 1: the starting point is awareness, not confirmation. All three tiers run from the date on which the manufacturer becomes aware, not from the date on which causation is confirmed. The death and serious-deterioration tier is the partial exception, since paragraph 5 starts the period from the date on which the manufacturer establishes or suspects the causal relationship, but that period is still capped at 10 days from awareness. This design forces companies to build an early reporting mechanism rather than waiting for an investigation to be complete before submitting anything. Teams that wait for certainty will find that the statutory clock has already run out, which is precisely the failure mode the drafting seeks to prevent.

Insight 2: the initial report provision is a practical tool for deadline management. Paragraph 6 expressly permits the submission of an initial report before the complete report where necessary to meet the deadline. This writes the principle of report first, supplement later into the legal text itself, giving companies a safe channel that cannot be criticised on the ground that the report was incomplete at submission. The practical consequence is that an initial report template should exist before any incident occurs, so that the clock is met by filing the template-based report while the investigation continues.

Insight 3: FSCAs carried out abroad must also be reported, an easily overlooked cross-border duty. Paragraph 1 subparagraph (b) brings field safety corrective actions performed outside Turkey or the European Union within the reporting scope, excluding only those whose reason is confined to markets outside Turkey and the European Union. The consequence deserves emphasis: a recall or corrective action in China, if the device is also placed on the Turkish market, can equally trigger a reporting obligation in Turkey. Global event lists should therefore be screened for Turkish market exposure whenever any corrective action is initiated anywhere.

Insight 4: Madde 87 paragraph 2 gives the Kurum its own power of evaluation. For serious incidents occurring within Turkey or FSCAs carried out or to be carried out in Turkey, the Kurum may conduct an evaluation under that paragraph. Companies should keep investigation materials readily retrievable for such an evaluation, because the authority will expect organised evidence rather than a scramble to assemble files after the request arrives.

4. Practical recommendations

• Configure the vigilance SOP with countdown timers on the 2 / 10 / 15 day tiers, and complete the tier classification at the moment the incident is logged.
• Maintain an initial report template so that a report can be submitted within the deadline even while the investigation is unfinished.
• Include in the cross-border FSCA trigger list all domestic suspensions, recalls and corrective actions in China, and have the Turkey-side owner review the list quarterly.
• File investigation dossiers in a retrievable structure so that a Kurum evaluation under Madde 87 paragraph 2 can be answered without delay.

5. Verification checklist

• □ The SOP has countdown timers on the 2 / 10 / 15 day tiers of Madde 85.
• □ The starting point has been defined as awareness, not confirmation.
• □ An initial report template has been prepared (paragraph 6).
• □ The duty to report foreign FSCAs has been added to the cross-border incident list (paragraph 1 subparagraph (b)).
• □ IVD projects now cite Madde 82—85 of the IVD Regulation, and distinguish Madde 86 (trends) from Madde 84 (PSUR).
• □ Investigation materials are retrievable for a Kurum evaluation.

Regulatory information verified as of 29 October 2026. The three-tier deadlines and the paragraph numbers cited in this article were checked sentence by sentence against the current texts on the Turkish legislation 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 adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com