Dear members, please see the new MDCG guidance regarding making available Medical Device Software, the guidance includes IVD software in scope. Note that this will also include provision of software via online platforms to Northern Ireland, as EU IVD Regulation also applies to Northern Ireland.
| MDCG 2025-4 – Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025) |
