Review

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)

Volume: 52 October 22, 2026
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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)

Abstract

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 In the European Union, Regulation 2017/745 (Medical Devices Regulation) superseded previous directives and strengthened the requirements for clinical evaluation, technical certification, post-market surveillance, and traceability.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.

Keywords

Supporting Institution

There is no supporting organization.

Project Number

There is no projects exist.

Ethical Statement

Literature sources were used in writing the review article. There is no study requiring ethics committee approval.

Thanks

There are no additional acknowledgments required for the writing of this review article.

References

  1. 1. Melvin T, Torre M. New medical device regulations: the regulator's view. EFORT Open Rev. 2019;4(6):351-6.
  2. 2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Off J Eur Union. 2017;L117:1-175.
  3. 3. Tıbbi Cihaz Yönetmeliği. T.C. Resmî Gazete, 2 Haziran 2021, Sayı: 31499 (1. Mükerrer). Ankara: Türkiye İlaç ve Tıbbi Cihaz Kurumu; 2021.
  4. 4. Migliore A. On the new regulation of medical devices in Europe. Expert Rev Med Devices. 2017;14(12):921-3.
  5. 5. International Organization for Standardization. ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes. Geneva: ISO; 2016.
  6. 6. International Organization for Standardization. ISO 14971:2019 Medical devices Application of risk management to medical devices. Geneva: ISO; 2019.
  7. 7. International Electrotechnical Commission. IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices. Geneva: IEC; 2015.
  8. 8. International Electrotechnical Commission. IEC 62304:2006 Medical device software life cycle processes. Geneva: IEC; 2006.

Details

Primary Language

English

Subjects

Health Care Administration, Health Services and Systems (Other)

Journal Section

Review

Publication Date

October 22, 2026

Submission Date

June 26, 2026

Acceptance Date

September 27, 2026

Published in Issue

Year 2026 Volume: 52

APA
Seçkin, U. D., Buhur, A., & Uyanıkgil, Y. (2026). 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). Journal of Uludağ University Medical Faculty, 52. https://doi.org/10.32708/uutfd.1979706
AMA
1.Seçkin UD, Buhur A, Uyanıkgil Y. 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). J Uludag Univ Med Fac. 2026;52. doi:10.32708/uutfd.1979706
Chicago
Seçkin, Umut Doğu, Aylin Buhur, and Yiğit Uyanıkgil. 2026. “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)”. Journal of Uludağ University Medical Faculty 52 (October). https://doi.org/10.32708/uutfd.1979706.
EndNote
Seçkin UD, Buhur A, Uyanıkgil Y (October 1, 2026) 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). Journal of Uludağ University Medical Faculty 52
IEEE
[1]U. D. Seçkin, A. Buhur, and Y. Uyanıkgil, “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)”, J Uludag Univ Med Fac, vol. 52, Oct. 2026, doi: 10.32708/uutfd.1979706.
ISNAD
Seçkin, Umut Doğu - Buhur, Aylin - Uyanıkgil, Yiğit. “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)”. Journal of Uludağ University Medical Faculty 52 (October 1, 2026). https://doi.org/10.32708/uutfd.1979706.
JAMA
1.Seçkin UD, Buhur A, Uyanıkgil Y. 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). J Uludag Univ Med Fac. 2026;52. doi:10.32708/uutfd.1979706.
MLA
Seçkin, Umut Doğu, et al. “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)”. Journal of Uludağ University Medical Faculty, vol. 52, Oct. 2026, doi:10.32708/uutfd.1979706.
Vancouver
1.Umut Doğu Seçkin, Aylin Buhur, Yiğit Uyanıkgil. 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). J Uludag Univ Med Fac. 2026 Oct. 1;52. doi:10.32708/uutfd.1979706

ISSN: 1300-414X, e-ISSN: 2645-9027

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Journal of Uludag University Medical Faculty is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
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