Guidance on In-House Devices Published

The EU Medical Device Coordination Group (MDCG) has released guidance document MDCG 2023-1 which explains the exemption of devices that are designed and developed in-house in EU-based health institutions. Such devices are typically developed to meet an unmet need, or unmet performance requirement, which cannot be provided by a CE-marked device. Although exempt from many of the Regulations’ requirements, In-house devices are regulated under Article 5(5) of the EU MDR and IVDR which lay down certain rules and requirements which will need to be met by the device and the health institution.

MDCG 2023-1