Two deadlines and a database: what EU MDR now asks of Turkish medical device manufacturers

Under the EU Medical Device Regulation, Regulation (EU) 2017/745, devices still sold on certificates issued under the old directives can stay on the EU market only until 31 December 2027 for class III and implantable class IIb devices, and 31 December 2028 for other class IIb, class IIa and certain class I devices. Regulation (EU) 2023/607 granted these extensions on strict conditions, including an application to a notified body by 26 May 2024 and a signed agreement by 26 September 2024. Since 28 May 2026 four modules of the European database EUDAMED have been mandatory: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. Manufacturers must register devices and keep the data current, with transitional periods for devices already on the market. The Commission proposed a targeted revision of the MDR on 16 December 2025. It could ease certificate renewal and some documentation, but it was still in the legislative process in October 2026 and does not change the 2027 and 2028 deadlines. For a Turkish manufacturer the decision is portfolio triage: which devices to certify in time, which to redesign, and which to withdraw.