In house device

The exemption lets hospitals make devices they need without CE marking, but only under strict conditions. The device cannot be transferred to another legal entity, and the institution must justify that no equivalent CE marked device meets the need.

A device that is manufactured and used only within a health institution established in the Union and that meets all conditions set in Article 5(5) of the MDR or IVDR (per MDCG 2023-1)

MDCG 2024-10, Section 1, Abbreviations and terminology