[
{
"regulation": "IVDR",
"sector": "healthcare",
"subsector": null,
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "IVDR regulates in vitro diagnostic medical devices for human use"
},
{
"regulation": "IVDR",
"sector": "healthcare",
"subsector": "laboratories",
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "Clinical laboratories using IVD devices are within scope"
},
{
"regulation": "IVDR",
"sector": "manufacturing",
"subsector": "diagnostics",
"applies": true,
"confidence": "definite",
"basis_article": "2",
"notes": "Manufacturers of IVD devices must obtain CE marking and comply with IVDR"
},
{
"regulation": "IVDR",
"sector": "digital_infrastructure",
"subsector": "software",
"applies": true,
"confidence": "likely",
"basis_article": "2",
"notes": "Software intended for IVD purposes is covered"
},
{
"regulation": "IVDR",
"sector": "financial",
"subsector": null,
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "Financial sector not in scope"
},
{
"regulation": "IVDR",
"sector": "energy",
"subsector": null,
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "Energy sector not in scope"
},
{
"regulation": "IVDR",
"sector": "other",
"subsector": "research",
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "Research-use only products are explicitly excluded from IVDR scope"
},
{
"regulation": "IVDR",
"sector": "other",
"subsector": "importers_distributors",
"applies": true,
"confidence": "definite",
"basis_article": "2",
"notes": "Importers and distributors of IVD devices have specific obligations"
}
]
