Research and Development Process, Regulatory Requirements and Clinical Trial of Medical Devices: A Review within the Framework of the Turkish Medicines and Medical Devices Agency (TITCK) and the European Union (Regulation 2017/745)

Medical devices encompass a wide range, from simple instruments to complex implants and software, and recent technological advancements have significantly increased both their number and clinical significance. Bringing a medical device from concept to clinical use requires an integrated pathway combining structured research and development, risk management, regulatory compliance, and robust clinical evidence. In the European Union, Regulation 2017/745 (Medical Devices Regulation) superseded previous directives and strengthened the requirements for clinical evaluation, technical certification, post-market surveillance, and traceability. Türkiye has aligned its national framework with this regulation through the Medical Devices Regulation published by the Turkish Medicines and Medical Devices Agency (TITCK). This review addresses the medical device lifecycle from a regulatory and scientific perspective, covering device definition and risk-based classification, the design and development process and the supporting quality and risk management standards, preclinical laboratory and biological evaluation, in vivo studies, and clinical evaluation and clinical research requirements. Particular attention is paid to the alignment between Good Clinical Practices (ISO 14155) and post-market obligations for device research within the Turkish (TITCK) and European (Regulation No. 2017/745) frameworks. Understanding this integrated pathway in the early stages of development is crucial for the efficient, compliant, and patient-centered transfer of medical devices to clinical practice.