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

This MDCG document addresses so-called “in house” devices, i.e., devices manufactured and used exclusively in health care facilities on a non-industrial scale to meet the specific needs of target patients that cannot be met by an equivalent CE-marked device on the market.

These in-house devices are exempted from many of the requirements of the MDR and IVDR provided that the healthcare institutions in charge of them comply with the conditions set forth in Article 5(5) of these regulations. This guide therefore provides recommendations on the application of these rules and is intended in particular for healthcare professionals who design, modify, or use this type of device in-house.