Only a week after the entry into force of Regulation (EU) 2017/745 of 5 April 2017 on Medical Devices (MDR), the Turkish Medicine and Medical Devices Authority (TİTCK) published the Medical Device Regulation ("Regulation") in the Official Gazette on 2 June 2021. The Regulation, which is fully harmonized with the EU legislation, aims to enhance the quality of medical devices and provide a more secure use for medical device users and patients.
On a risk-based approach, new devices such as contact lenses, liposuction equipment, products that are applied to 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 are included in the scope of the Regulation. Obligations concerning these devices will take effect as of six months from the date of publication of the common specifications of the EU Commission. Additionally, the Regulation brings enhanced quality requirements for medical devices including the after-sale period. Namely, device manufacturers must supervise the safety of the products and determine an appropriate policy in terms of preventive and remedial measures against potential safety issues. The Regulation also adopts the EU Medical Device Database (EUDAMED) system of the EU Commission. Accordingly, all medical devices must be registered on EUDAMED prior to being placed on the market. As the records will be open to the public, the relevant database will provide great transparency in the medical device sector. EUDAMED will be available in Turkey within six months of its the date of publication in the EU Official Journal as well as the notification concerning the fulfillment of functional specifications.
The Regulation sets forth essential changes in terms of medical devices legislation. It is expected to enhance the international trade of medical devices between Turkey and Europe. Companies working in this sector must carefully assess the Regulation and take the necessary measures to ensure compliance by the deadline.