The Medical Devices Regulation 2017/745/EU Medical Devices Regulation (MDR) is a directly applicable European Union regulation issued to ensure that medical devices are placed on the market in a safe, effective, and traceable manner. It entered into force on 26 May 2021, replacing the former MDD/AIMDD directives. In Türkiye, it is implemented under the same framework as the Medical Devices Regulation.
The regulation adopts a risk-based approach; devices are classified according to their intended use and their impact on the human body, and as the risk level increases, the level of technical, clinical, and administrative evidence required from the manufacturer also increases. Compared to previous legislation, MDR significantly strengthens clinical evaluation and clinical evidence requirements, restricts the concept of “equivalent device,” and effectively mandates clinical investigations, particularly for high-risk devices.
Under MDR, manufacturers are required to establish a comprehensive risk management system covering the entire lifecycle of the device, prepare detailed technical documentation, maintain up-to-date clinical evaluation reports, and implement post-market surveillance (PMS) and periodic safety update reports (PSUR). In addition, a vigilance system is mandatory for monitoring serious incidents and corrective actions. To ensure traceability, the Unique Device Identification (UDI) system has been introduced, and all relevant information must be registered in the European central database, EUDAMED.
Except for certain low-risk Class I devices, the involvement of a Notified Body is mandatory for medium- and high-risk devices. These bodies perform conformity assessment activities forming the basis for CE marking by evaluating the technical documentation, quality management system, and, where applicable, conducting design examinations.