Medical Device Regulation

The Medical Device Regulation (Tıbbi Cihaz Yönetmeliği), published in the repeated issue of Official Gazette No. 31499 of 2 June 2021, sets the procedures for placing medical devices for human use and their accessories on the market, making them available and putting them into service, on the basis of a high level of protection of the health of patients, users and other persons (Article 1). It was prepared taking into account Regulation (EU) 2017/745 of 5 April 2017 on medical devices (Article 109) and repealed the Medical Device Regulation and the Active Implantable Medical Devices Regulation published in Official Gazette No. 27957 of 7 June 2011 (Article 110). It is administered by the Turkish Medicines and Medical Devices Agency.

What does the Medical Device Regulation cover and exclude?

The Regulation applies to all medical devices and their accessories except in vitro diagnostic devices, and also covers certain non-medical product groups listed in Annex XVI and clinical investigations (Article 1). In vitro diagnostic devices are subject to a separate regulation published on the same date. The Regulation has been amended three times, in the Official Gazettes of 29 July 2022 (No. 31907), 2 April 2023 (No. 32151) and 17 August 2024 (No. 32635).

What must manufacturers, importers and distributors do about a non-compliant device?

A manufacturer that considers, or has reason to believe, that a device it has placed on the market or put into service does not conform must promptly take the appropriate corrective action, such as bringing the device into conformity, withdrawing it or recalling it, and inform its distributors, authorised representative and importers. If the device presents a serious risk, the Agency must also be informed (Article 10(12)). The manufacturer sets up a system for recording and reporting adverse events and field safety corrective actions (Article 10(13)).

Importers and distributors who consider a device non-conforming do not make it available until it is brought into conformity; they inform the manufacturer and others as required and keep records of complaints, non-conforming devices and withdrawals (Articles 13 and 14). Under the definitions, “withdrawal” is any measure aimed at preventing a device in the supply chain from being made available, and “recall” is any measure aimed at achieving the return of a device already supplied to the end user to the economic operator (Article 3).

How do field safety corrective actions and vigilance work?

A field safety corrective action is a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in connection with a device made available on the market (Article 3). Manufacturers report every serious incident and every field safety corrective action to the Agency (Article 85(1)). The time limits depend on the gravity of the event:

• as a general rule, no later than 15 days after becoming aware of the incident
• no later than 2 days in the case of a serious public health threat
• no later than 10 days in the case of death or unanticipated serious deterioration in health
• a field safety corrective action is reported without delay before it is undertaken, except in urgent cases

The manufacturer carries out the necessary investigations without delay and, while an investigation is under way, does not alter the device or a sample of the batch concerned without informing the Agency (Article 87).

What powers does the Agency have in market surveillance?

The Agency checks the conformity of devices through documentation reviews, physical checks and laboratory tests, and carries out announced or unannounced inspections (Article 90). If it has reason to believe that a device may present an unacceptable risk, it carries out an evaluation (Article 91). If it finds an unacceptable risk, it requires the manufacturer, within a reasonable period, to bring the device into conformity, restrict its availability, withdraw it or recall it; if the operator does not take adequate corrective action, the Agency itself takes the measures to prohibit, restrict, withdraw or recall the device (Article 92). Similar measures may apply where non-conformity is not remedied even though no unacceptable risk exists (Article 94).

What does it mean for destruction and waste?

The Regulation has no provision on the disposal as waste of recalled or withdrawn devices. The only provision that refers directly to destruction is Article 90(5): where necessary to protect public health, the Agency may take measures to seize counterfeit devices or devices presenting an unacceptable risk, and may destroy them or otherwise render them unusable.

The management of material that later arises as medical waste is therefore a matter for waste and health legislation, not for this Regulation. The Regulation ties the fate of a product after a recall or withdrawal to the corrective-action process between the competent authority and the manufacturer and contains no detailed destruction procedure.