EU Guidance Details When In-House Devices Are Exempt From MDR and IVDR

Another MDCG guidance document is out. It elaborates on Article 5(5) of the new EU medtech regulations, which spares devices made and used in health institutions from needing to conform with most MDR/IVDR requirements.

Medical devices for use within EU health institutions, known as in-house devices, are exempted from most of the legal requirements set out in the Medical Device and In Vitro Diagnostics Regulations (MDR/IVDR). This is provided that no equivalent CE-marked device is available to meet the needs of target patient groups.

Such products are the focus of the latest 20-page guidance document endorsed by the Medical Device Coordination Group (MDCG). The...