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.




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