Kas reglamentuoja klinikinius tyrimus ir vertinimą?

Klinikinių tyrimų ir vertinimo reglamentai:

• • Europos Parlamento ir Tarybos reglamentas (ES) 2017/745
• • Lietuvos Respublikos biomedicininių tyrimų etikos įstatymas
• • MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation, December 2021
• • MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations July 2021
• • MDCG 2021-8 Clinical investigation application/notification documents May 2021
• • MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation April 2021
• • MDCG 2020-13 Clinical evaluation assessment report template, July 2020
• • MDCG 2020-10/1 Guidance on safety reporting in clinical investigations, May 2020
• • MDCG 2020-10/2 Appendix: Clinical investigation summary safety report form, May 2020
• • MDCG 2020-8 Guidance on PMCF evaluation report template, April 2020
• • MDCG 2020-7 Guidance on PMCF plan template, April 2020
• • MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices. Background noteSearch for available translations of the preceding linkEN•••on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation April 2020
• • MDCG 2020-5 Guidance on clinical evaluation – Equivalence April 2020
• • MDCG 2019-9 – Rev.1 Summary of safety and clinical performance March 2022.