[MDCG 가이던스] MDCG 2023-1: MDR/IVDR 제5조(5)에 따른 의료기관 예외 가이던스

안녕하세요. GRC 인증원입니다.

MDCG 2023-1 : MDR/IVDR 제5조(5)에 따른 의료기관 예외 가이던스에 대해 알아보겠습니다. Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDR/IVDR Article 5(5) 5.

With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the followi...