Article 27: manufacturers of medical devices and in vitro diagnostic devices, and providers of high-risk AI systems outside those regimes, that claim interoperability with the harmonised components of EHR systems must prove compliance with the Annex II section 2 essential requirements on the interoperability and logging components, with Article 36 common specifications applying; Article 49(3) requires them to register also in their own sector databases with data forwarded to the EHDS database.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.