Tıbbi Cihazların Araştırma ve Geliştirme Süreci, Mevzuat Gereklilikleri ve Klinik Denemeleri: Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) ve Avrupa Birliği Çerçevesinde Bir İnceleme (2017/745 Sayılı Yönetmelik)

Öz

Tıbbi cihazlar, basit aletlerden karmaşık implantlara ve yazılımlara kadar geniş bir yelpazeyi kapsar ve son teknolojik gelişmeler hem sayılarını hem de klinik önemlerini önemli ölçüde artırmıştır. Bir tıbbi cihazı kavram aşamasından klinik kullanıma getirmek, yapılandırılmış araştırma ve geliştirme, risk yönetimi, mevzuata uygunluk ve sağlam klinik kanıtları birleştiren bütünleşmiş bir yol gerektirir. Avrupa Birliği'nde, 2017/745 sayılı Yönetmelik (Tıbbi Cihaz Yönetmeliği), önceki direktiflerin yerini almış ve klinik değerlendirme, teknik belgelendirme, piyasa sonrası gözetim ve izlenebilirlik gerekliliklerini güçlendirmiştir. Türkiye, Türk İlaç ve Tıbbi Cihazlar Ajansı (TİTCK) tarafından yayımlanan Tıbbi Cihaz Yönetmeliği ile ulusal çerçevesini bu yönetmelikle uyumlu hale getirmiştir. Bu derleme kapsamında, tıbbi cihaz yaşam döngüsünü düzenleyici ve bilimsel bir perspektiften ele alarak, cihaz tanımı ve risk tabanlı sınıflandırma, tasarım ve geliştirme süreci ve bunu destekleyen kalite ve risk yönetimi standartları, preklinik laboratuvar ve biyolojik değerlendirme, in vivo çalışmaları ve klinik değerlendirme ve klinik araştırma gerekliliklerini ele almaktadır. Özellikle Türk (TİTCK) ve Avrupa (2017/745 sayılı Yönetmelik) çerçeveleri, cihaz araştırmaları için İyi Klinik Uygulamalar (ISO 14155) ve piyasa sonrası yükümlülükler arasındaki uyuma dikkat edilmektedir. Geliştirmenin erken aşamalarında bu bütünleşmiş yolu anlamak, tıbbi cihazların klinik uygulamaya verimli, uyumlu ve hasta merkezli bir şekilde aktarılması için çok önemlidir.

Anahtar Kelimeler

• biyomalzemeler
• tıbbi cihaz
• kalite ve regülasyon
• preklinik çalışmalar
• klinik araştırmalar

Destekleyen Kurum

Destekleyen bir kuruluş bulunmamaktadır.

Proje Numarası

There is no projects exist.

Etik Beyan

Derleme makalesinin yazımında literatür kaynaklarından yararlanılmıştır. Etik kurul onayı gerektiren herhangi bir çalışma bulunmamaktadır.

Teşekkür

Bu derleme makalesinin yazımı için ek bir teşekkür veya teşekkür ifadesine gerek yoktur.

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)

Öz

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.

Anahtar Kelimeler

• Biomaterials
• medical device
• quality and regulation
• preclinical studies
• clinical trials

Destekleyen Kurum

There is no supporting organization.

Proje Numarası

There is no projects exist.

Etik Beyan

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

Teşekkür

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

Kaynakça

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