The MHRA yesterday outlined planned significant updates to UK Medical Device Regulations. The changes include updating the scope of the Regulations, changing the classification of in-vitro diagnostics devices (IVD) and change the Essential Requirements. The definition of 'in-vitro diagnostic devices' will now include software and devices intended for diagnosing physical or mental impairments, predispositions to medical conditions or diseases, and…
Ben KempMarch 6, 2024