The Medical Device Regulation (“Regulation“) was published in Official Gazette No. 31499 on 2 June 2021. The Regulation, which is fully harmonized with the European Union (EU) legislation, aims to enhance the quality of medical devices and provide a more secure use for medical device users and patients. The Regulation is available (in Turkish) here.
Extended scope of medical devices
The Regulation extends the scope of medical devices. Accordingly, devices such as contact lenses, liposuction equipment, products that are applied on the human body with invasive surgical equipment (except for tattoo and piercing equipment), products that are used for facial and other types of dermal filling, laser equipment and brain simulation equipment will be considered medical devices. All obligations arising from the Regulation concerning the abovementioned devices and products will apply as of six months from the date of publication of the EU Commission’s common specifications. The existing legislation will be effective until then.
New quality requirements
According to the Regulation, a device must meet enhanced quality requirements in order to be placed on the market. Device manufacturers must establish a quality management system that must address certain aspects, such as a clear strategy concerning compliance with the Regulation, resource management in terms of supplier and contractor choice, clinical assessment and risk management. The quality management system must also include a market supervision strategy that addresses the period following the placement of the product on the market. Accordingly, device manufacturers must supervise the safety of the products and determine an appropriate policy in terms of preventive and remedial measures to adopt in the case of safety issues.
Clinical research for medical devices
All medical devices (except for on-demand produced and devices produced for research purposes) must be clinically tested prior to use. Manufacturers are obliged to complete this process in order to place a medical device on the market. The clinical research must be planned and conducted in accordance with the national legislation and international best practices concerning medical and clinical research.
EU Medical Device Database (EUDAMED)
The Regulation implements the EUDAMED system of the EU Commission in order to enhance transparency and improve traceability in the medical device industry. According to the Regulation, manufacturers must register all medical devices (except for on-demand devices) with EUDAMED prior to placing them on the market. EUDAMED records are open to the public. Therefore, records must be kept in a clear and understandable language. The system will be ready to use within six months of the date of publication in the Official Journal of the EU and notification concerning the fulfilment of functional specifications.
The Regulation sets forth essential changes in terms of medical devices legislation. Companies working in this sector must carefully assess the Regulation and take necessary measures to ensure compliance by the deadline.