In light of harmonization with the European Union (“EU”) legislation regarding medical devices, a new Turkish Medical Devices Regulation (“Regulation”) that is aligned with the Regulation (EU) 2017/745 of the European Parliament and of the Council (“EU Regulation”) has been published in the Official Gazette No. 31499 on June 2, 2021. Save for certain provisions, the Regulation entered into force as of May 26, 2021.
The Regulation aims at providing a high level of protection of health for patients, users and third parties, and high standards of quality and safety for medical devices, as well as rules for the placing on the market and putting into service of medical devices and their accessories. Furthermore, the Regulation sets out various procedures in order to establish a robust, transparent, predictable and sustainable regulatory framework for clinical investigations conducted for medical devices and their accessories.
Turkish Medicines and Medical Devices Agency ("Agency") is authorized as the competent authority in charge of enforcement of the Regulation.
Changes
Expansion of products
The scope of products regarded as medical devices is extended with the Regulation as it encompasses certain product groups that have non-medical purposes, such as contact lenses, products to be applied to the human body by invasive means (except tattoo products and piercings), liposuction equipment, lasers intended for skin treatment and brain stimulation equipment.
Distance diagnostic or therapeutic services must also comply with the Regulation.
Quality Requirements
According to the Regulation, devices must meet general safety and performance requirements, among which include performance qualifications, risk management system, design and manufacturing requirements, label and instruction manual requirements, and quality management system, in order to be placed on the market or put into service. Devices must also be clinically tested.
On the other hand, devices that are in conformity with the relevant harmonized standards of the EU Regulation are also considered to have met the requirements of the Regulation.
The Agency has the authority to request additional information about said medical devices, control their activities and restrict manufacture or use of them.
UDI and EUDAMED
The Regulation defines the Unique Device Identification (“UDI”) System which allows identification and facilitates traceability of devices with the exception of custom-made and research-oriented devices. European Database on Medical Device (“EUDAMED”), besides the UDI system, is also implemented in order to enable the public to be adequately informed about devices, corresponding certificates and clinical investigations, facilitate traceability, and allow manufacturers to fulfill their legal obligations.
Obligations of Manufacturers, Importers and Distributors
The Regulation implements many obligations on the part of manufacturers, importers and distributors. In particular, manufacturers are obliged to, among others, assure the conformity of devices to the Regulation, establish a risk management, quality management and post-market supervision system, conduct clinical evaluations, and prepare and update technical documentation for their devices. Additionally, manufacturers are required to have at least one person responsible for regulatory compliance who possesses the stipulated level of requisite expertise in the field available within their organization.
Designation of an authorized representative is required for manufacturers who are not established in an EU Member State or in Turkey and a device may only be placed on the market with the designation of an authorized representative.
Sanctions
With regard to violations of the provisions of the Regulation, Product Safety and Technical Regulations Law, the Turkish Penal Code and other relevant legislation are applied.
Conclusion
The Regulation, aiming at being compliant with the EU Regulation, brings forth many changes as well as novelties to the Turkish regulations on medical devices. Therefore, it is highly important for the involved companies, especially manufacturers, importers and distributors, to assure compliance with the Regulation.
