Ülkeler Arasındaki Tıbbi Cihaz Düzenlemelerinin Karşılaştırmalı Bir Analizi

Yıl 2025, Cilt: 34 Sayı: 4, 282 - 293, 24.12.2025

Ezgi Birken , Hande Gürer-Orhan

https://doi.org/10.17827/aktd.1816848

Öz

Tıbbi cihazlar, insanlarda hastalıkların tanı, tedavi ve önlenmesinde kullanılan temel araçlardır. Bu derleme makalesi Amerika Birleşik Devletleri (ABD), Avrupa Birliği (AB) ve Türkiye’de tıbbi cihazları düzenleyen sistemlerin karşılaştırmalı analizini sunmaktadır. ABD’de Gıda ve İlaç Dairesi (FDA) yüksek riskli cihazlar için “Pazarlama Öncesi Onay”, emsal cihazlara eşdeğerlik esasına dayalı “510(k) bildirim sistemi” ve düşük-orta risk düzeyine sahip yenilikçi cihazlar için “De Novo yolağı” gibi risk temelli düzenleme yolları uygulamaktadır. AB’de büyük güvenlilik zafiyeti olaylarını takiben düzenleyici Direktiflerden Tıbbi Cihaz Yönetmeliğine (MDR 2017/745) geçişle sistem güçlendirilmiştir. Söz konusu yönetmelik klinik değerlendirmeye daha sıkı yaklaşım, güçlendirilmiş piyasa sonrası gözetim, Avrupa Tıbbi Cihaz Veri Tabanı’na zorunlu kayıt, Benzersiz Cihaz Tanımlama (UDI) sisteminin uygulanması ve “Onaylanmış Kuruluşlar”ın (Notified Bodies) artan denetimi gibi daha katı kurallar getirmiştir. Türkiye (TİTCK), MDR’ı uygulayarak AB düzenlemeleriyle uyum sağlamış ve cihazların üretimden son kullanıcıya kadar etkin izlenebilirliğini sağlamak amacıyla Ürün Takip Sistemi’ni (ÜTS) oluşturmuştur. Tüm bunların yanında piyasa öncesi güvenlilik değerlendirmesinde biyouyumluluk testleri kritik bir gerekliliktir ve özellikle yüksek riskli cihazlar için önemli rol oynamaktadır. “Büyük Üçlü” test—sitotoksisite, irritasyon ve duyarlılık—cihazların temas süresi veya risk kategorisinden bağımsız olarak neredeyse tüm cihazlar için zorunludur. Bununla birlikte, test gerekliliklerinde, ABD’nin hâlâ irritasyon için in vivo tavşan modeli talep edilirken AB’nin in vitro modelleri benimsemesi gibi farklılıklar, küresel tıbbi cihaz endüstrisi için küresel uyumluluğu zorlaştırmakta ve çift test yapma zahmetine neden olmaktadır.

Anahtar Kelimeler

Tıbbi Cihaz Düzenlemesi , Gıda ve İlaç İdaresi , Türkiye İlaç ve Tıbbi Cihaz Kurumu , Biyouyumluluk testleri

A Comperative Study of Medical Device Regulation Between Countries

Öz

Medical devices are fundamental tools used for the diagnosis, treatment, and prevention of diseases in humans. This review article provides a comparative analysis of the regulatory systems governing medical devices in the United States (US), the European Union (EU) and Turkey. In the US, the Food and Drug Administration (FDA) employs risk-based pathways such as “Premarket Approval” (PMA) for high-risk devices, the “510(k) notification system” based on equivalence to predicate devices and the “De Novo pathway” for novel devices carrying low-to-moderate risk. In the EU, following major safety incidents, regulatory oversight was strengthened by transitioning from Directives to the Medical Device Regulation (MDR 2017/745). The MDR introduced stricter rules focusing on clinical evaluation, enhanced post-market surveillance, mandatory registration on the European Medical Device Database (EUDAMED), implementation of UDI (Unique Device Identification) and increased oversight of Notified Bodies. Turkey (TİTCK) has harmonized its regulations with the EU, implementing the MDR and establishing the Product Tracking System (ÜTS) to ensure effective traceability of devices from manufacturing until they reach the final user. Furthermore, biocompatibility testing is a core requirement in the pre-market safety assessment, particularly for high-risk devices. The "Big Three" tests—cytotoxicity, irritation, and sensitization—are required for almost all devices regardless of contact duration or risk category. However, discrepancies in testing requirements, such as the US still requiring in vivo rabbit data for irritation while the EU adopts in vitro models, pose a significant challenge and contribute to dual testing burdens for the global medical device industry.

Anahtar Kelimeler

Medical Device Regulation , Food and Drug Administration , Turkish Medicines and Medical Devices Agency , Biocompatibility tests

Kaynakça

• 1. T.C Resmî gazete. Available from: https://www.resmigazete.gov.tr/eskiler/2021/06/20210602M1.pdf. Accessed: 02.06.2021.
• 2. World Health Organization. Medical devices. Available from: https://www.who.int/health-topics/medical-devices. Accessed:2025.
• 3. Bayrak, T., Yilmaz, E. S. What will be the economic impact of the new medical device regulation? An interrupted time-series analysis of foreign trade data. Value in Health Regional Issues. 2022;29:1-7.
• 4. Kandorova, H., Pobis, P. The “Big Three” in biocompatibility testing of medical devices: implementation of alternatives to animal experimentation—are we there yet?. Frontiers in Toxicology. 5, 1337468, 2024.
• 5. Food and Drug Administration (FDA).Available from: https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-ii-1938-food-drug-cosmetic-act. Accessed:25.07.1938.
• 6. Food and Drug Administration (FDA).Available from: https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states. Accessed:21.08.2023.
• 7. Centers for Disease Control and Prevention (CDC).Intrauterine contraceptive device-associated septic abortions-United States, 1973–1975. Morbidity and Mortality Weekly Report. 1975;24(29):261–262.
• 8. MacGregor, D. C., Noble, E. J., Morrow, J. D., Scully, H. E., Covvey, H. D., & Goldman, B. S. Management of a pacemaker recall. The Journal of Thoracic and Cardiovascular Surgery. 1977;74(5):657-667.
• 9. DeForge, W. F. Cardiac pacemakers: a basic review of the history and current technology. Journal of Veterinary Cardiology. 2019;22:40-50.
• 10. Food and Drug Administration (FDA). Available from: https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-iv-regulating-cosmetics-devices-and-veterinary-medicine-after-1938. Accessed:02.01.2018.
• 11. Food and Drug Administration (FDA). Medical Device Amendments of 1976: Public Law 94-295. Washington, D.C.: U.S. Government Printing Office.
• 12. Pisac, A., Wilson, N. FDA device oversight from 1906 to the present. AMA Journal of Ethics.2021; 23(9):712-720.
• 13. Zuckerman, D. M., Brown, P., Nissen, S. E. Medical device recalls and the FDA approval process. Archives of internal medicine. 2011;171(11):1006-1011.
• 14. Fink, M.,Akra, B. Comparison of the international regulations for medical devices–USA versus Europe. Injury, 54, 110908, 2023.
• 15. 21st Century Cures Act. Public Law No 114-255 Avaible from: https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. Accessed:13.12.2016.
• 16. Sherkow, J. S., Aboy, M. The FDA De Novo medical device pathway, patents and anticompetition. Nature Biotechnology. 2020;38(9):1028-1029.
• 17. Muehlematter, U. J., Daniore, P., Vokinger, K. N.Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): a comparative analysis. The Lancet Digital Health. 2021;3(3):e195-e203.
• 18. Food and Drug Administration (FDA). Proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD): Discussion paper and request for feedback. Avaible from: https://www.fda.gov/media/122535/download. Accessed:2019.
• 19. European Commission, Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.Available from: https://eur-lex.europa.eu/eli/dir/1990/385/oj/eng. Accessed: 20.07.1990.
• 20. European Commission, Council Directive 93/42/EEC Available from: https://eur-lex.europa.eu/eli/dir/1993/42/oj/eng. Accessed:14.07.1993.
• 21. European Commission, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). Available from: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_034.pdf. Accessed: 01.02.2012.
• 22. Regulation (EU) 2017/745 of The European Parliament and of the Council. Available from: REGULATION (EU) 2017/ 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 5 April 2017 - on medical devices, amending Directive 2001/ 83/ EC, Regulation (EC) No 178/ 2002 and Regulation (EC) No 1223/ 2009 and repealing Council Directives 90/ 385/ EEC and 93/ 42/ EEC Accessed:05.04.2017.
• 23. Regulation (EU) 2017/746 of The European Parliament and of the Council. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN. Accessed:05.04.2017.
• 24. Kaya, E. Tıbbi Cihaz Mevzuatı Değişikliği ve Yeni Yasal Yükümlülükler (Yüksek Lisans Tezi). İzmir, Dokuz Eylül Üniversitesi,2022.
• 25. T.C Resmi gazete. Available from https://www.mevzuat.gov.tr/MevzuatMetin/1.5.4703-20010629.pdf.Accessed: 13.03.2002.
• 26. T.C Resmi gazete. Available from: https://www.resmigazete.gov.tr/eskiler/2002/03/20020313.htm#7.Accessed: 13.03.2002.
• 27. T.C Resmi gazete. Available from: https://www.resmigazete.gov.tr/eskiler/2003/10/20031014.htm#6. Accessed: 14.10.2003.
• 28. T.C Resmi gazete. Available from: https://www.resmigazete.gov.tr/eskiler/2011/11/20111102M1-3.htm. Accessed: 02.11.2011.
• 29. Türkiye İlaç ve Tıbbi Cihaz Kurum. “Proje Hakkında.” Available from: https://uts.saglik.gov.tr/?page_id=33. Accessed:02.03.2023.
• 30. Uslu, D. ve Demircan, F. Ürün Takip Sistemi (ÜTS) Kullanılabilirlik Değerlendirilmesi: Tıbbi Cihaz Firmalarına Yönelik Bir Çalışma. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi.2023;12(3):1026-1031.
• 31. Philips FSN Geri Çağırma Bildirimi. Available from: https://www.philips.com.tr/c-dam/b2bhc/master/landing-pages/src/update/documents/rcpap-and-ventilator-fsn-letter-tr-final-21-june-2021.pdf. Accessed: 21.06.2021.
• 32. European Commission, Medical Device Coordination Group (MDCG). Available from: https://health.ec.europa.eu/document/download/3913729e-a2a6-44e0-a231-abc06406c49a_en?filename=mdcg_md-ivd_members_en.pdf. Accessed: 20.11.2024.
• 33. European Commission, Medical Device Coordination Group (MDCG). MDCG endorsed documents and other guidance. Available from: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en .
• 34. Chen, Y. J., Chiou, C. M., Huang, Y. W., Tu, P. W., Lee, Y. C. Ve Chien, C. H. A comparative study of medical device regulations: US, Europe, Canada, and Taiwan. Therapeutic innovation & regulatory science.2018;52(1):62-69.
• 35. Chai, J. Y. Medical device regulation in the United States and the European Union: a comparative study. Food and drug law journal.2000;55(1):57-80.
• 36. DePuy ASR Hip Recall - System Revisions & Recall Information. Available from: https://www.drugwatch.com/hip-replacement/depuy/recall/. Accessed: 28.03.2023.
• 37. Chettri, B., & Ravi, R. A comparative study of medical device regulation between countries based on their economies. Expert Review of Medical Devices.2024;21(6):467-478.
• 38. Giordano, A., Silvestre, A., Pieri, & M., Vacchiano, G. On a defective Mitraclip© system: Considerations on the medical device regulation in Europe. Monaldi Archives for Chest Disease.2018; 88(3).
• 39. Heneghan, C., Langton, D., & Thompson, M. Ongoing problems with metal-on-metal hip implants. Bmj.2012;344.
• 40. Greco, C. The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering. Social science & medicine.2015;147:150-157.
• 41. Food and Drug Administration (FDA).MAUDE – Manufacturer and User Facility Device Experience database. U.S. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed: 2023.
• 42. Fuller, J., Ashar, B. S., & Carey-Corrado, J.Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA. Journal of minimally invasive gynecology.2005;12(4):302-307.
• 43. European Commission, Regulation (EU) 2022/123 Of The European Parliament and of the Council. Available from: https://eur-lex.europa.eu/eli/reg/2022/123/oj/eng. Accessed: 25.01.2022.
• 44. International Organization for Standardization (ISO).Biological evaluation of medical devices- Part 1 Evaluation and testing within a risk management process. Available from: https://www.iso.org/standard/68936.html. Accessed: 2018.
• 45. International Organization for Standardization (ISO). Biological evaluation of medical devices-Part 12 Sample preparation and reference materials. Available from: https://www.iso.org/standard/75769.html. Accessed:2021.
• 46. International Organization for Standardization (ISO).Biological evaluation of medical devices - Part 5 Tests for in vitro cytotoxicity. Available from: https://www.iso.org/standard/36406.html. Accessed: 13.07.2010.
• 47. Reeve, L., Baldrick, P. Biocompatibility assessments for medical devices–evolving regulatory considerations. Expert Review of Medical Devices, 2017;14(2): 161-167.
• 48. International Organization for Standardization (ISO). Biological evaluation of medical devices-Part 10 Tests for skin sensitization. Available from: https://www.iso.org/standard/75279.html. Accessed: 2021.
• 49. International Organization for Standardization (ISO). Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices. Available from: https://www.iso.org/standard/83916.html. Accessed: 2023.
• 50. Organisation for economic cooperation and development (OECD).Guideline for the testing of chemicals, skin sensitization: local lymph node assay, Test Guideline 429 Accessed:22.07.2010.
• 51. Organisation for economic cooperation and development(OECD).Guideline for the testing of chemicals, skin sensitization: local lymph node assay: DA test guideline 442A Accessed:22.07.2010.
• 52. Organisation for economic cooperation and development (OECD).Guideline for the testing of chemicals, skin sensitization: local lymph node assay: BrdU-ELISA. Test Guideline 442B Accessed:22.07.2010.
• 53. Organisation for economic cooperation and development (OECD).Guideline for testing of chemicals, skin sensitisation, test guideline 406, adopted by the council. Accessed:17.07.1992.
• 54. Organisation for economic cooperation and development guideline for the testing of chemicals, skin sensitization: local lymph node assay test guideline 429, Accessed:22.07.2010.
• 55. Organisation for Economic Cooperation and Development (OECD).Guideline For The Testing of Chemicals. In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA), Test Guideline 442C, Accessed:04.02.2015.
• 56. Organisation for Economic Cooperation and Development (OECD).Guideline For The Testing of Chemicals Accessed:04.02.2015.
• 57. Organisation for economic cooperation and development (OECD).Guideline for the testing of chemicals. In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT), Test Guideline 442E, Accessed:29.07.2016.
• 58. International Organization for Standardization (ISO).Biological evaluation of medical devices - Part 2: Animal welfare requirements. Available from: https://www.iso.org/standard/78866.html. Accessed: 2022.
• 59. International Organization for Standardization (ISO).Biological evaluation of medical devices- Part 23 Tests for irritation. Available from: https://www.iso.org/standard/74151.html Accessed: 2021.
• 60. Food and Drug Administration (FDA). Recognized consensus standards: medical devices. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=42430. Accessed: 06.07.2021.
• 61. De Jong, W. H., Hoffmann, S., Lee, M., Kandárová, H., Pellevoisin, C., Haishima, Y., et all. Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts. Toxicol vitro.2018;50 (8):439–449.