MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2023-1 which aims to support a harmonised application of Article 5(5) of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). This document is written for healthcare professionals and researchers working in health institutions who design, manufacture, modify, refurbish and use in-house devices.

The guidance provides in Annex A a model of declaration to be drawn up by an authorised person of the health institution in the event of the manufacture and use of an in-house device as well as a timeline in Annex B indicating the dates on which the provisions of Article 5(5) of the IVDR come into force. Article 5(5) of the MDR is fully applicable as of 26 May 2021.

DOWNLOAD THE GUIDANCE MDCG 2023-1