EU Member States and European Commission adopt a Medical Device Software Hardware combinations Guidance
On 18 October 2023, the Medical Device Coordination Group (MDCG), a group composed of representatives of all Member States and chaired by a representative of the European Commission, adopted a Medical Device Software (MDSW) Hardware combinations Guidance. This Guidance is aimed at helping manufacturers of medical software understand how to make products in conformity with the applicable regulatory requirements when combining MDSW with hardware or hardware components. This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are tackled in other guidance.
