Medical device legislation changed fundamentally with the Medical Devices Regulation (MDR), adopted in the European Union in 2017 and applicable since 2021. In line with its alignment obligations under the Customs Union, Türkiye transposed this change into its domestic law through the Medical Device Regulation published in the Official Gazette of 2 June 2021. A similar regulation for in vitro diagnostic devices also entered into force separately.
Who is subject to obligations?
The Regulation imposes separate obligations on each actor in the supply chain of a device:
- Manufacturer: Responsible for the design and manufacture of the device and its conformity with the general safety and performance requirements, for preparing the technical documentation and for the conformity assessment.
- Authorised representative: Assumes certain tasks on behalf of a manufacturer established outside Türkiye and may be held liable jointly with the manufacturer.
- Importer: Verifies, before placing the device on the market, that the device bears the conformity marking, that the declaration of conformity has been drawn up and that the labelling is complete.
- Distributor: Checks that the device it makes available for sale has the required markings and documents and, where non-conformity is suspected, does not make the device available on the market.
Classification and conformity assessment
Devices are classified according to their level of risk. The higher the class, the greater the involvement of the notified body in the process. Under the new rules, clinical evaluation requirements have been made more stringent and certain product groups have been moved into a higher risk class.
Registration and traceability
Medical devices placed on the market in Türkiye must be registered in the Product Tracking System (ÜTS) administered by the Medicines and Medical Devices Agency (TİTCK). The Regulation also introduces the unique device identification (UDI) system, with the aim of making every device traceable throughout the supply chain.
Post-market surveillance and vigilance
The manufacturer’s responsibility continues after the device has been placed on the market. The manufacturer must systematically monitor the performance and safety of the device and report serious incidents and field safety corrective actions to the competent authority. This obligation is also an important criterion in product liability actions when assessing whether the manufacturer has fulfilled its duty of care.
Assessment
The new regime has transformed the medical device from “a product that is manufactured and sold” into an object of responsibility monitored throughout its life cycle. For health technology start-ups and importers, the problem encountered most frequently is that contracts do not clearly specify which actor bears which obligations. It is advisable to revise distribution and authorised representative agreements in the light of these obligations.