Italy | "In house" medical devices, EU indications regarding the conditions that health institutions must respect

The Medical Device Coordination Group (MDCG) has released guidelines for health institutions on the use of medical devices that are manufactured and used exclusively within the European Union (EU) in accordance with the EU Regulation 2017/745 and 2017/746.

These guidelines, MDCG 2023-1, have been developed following a prolonged discussion within the EU community and provide guidance for health institutions on the conditions that must be met when using devices made in-house. The guidelines aim to support a uniform application of these regulations by healthcare providers and researchers who design, manufacture, modify and use in-house medical devices.

The guidelines include definitions and examples, as well as sections dedicated to topics such as quality management, the meaning of "specific needs of target patient groups," and documentation to support the need for in-house devices in the absence of CE-marked equivalents. 

LINK TO 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