[
{
"regulation": "MDR",
"sector": "healthcare",
"subsector": null,
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "MDR regulates medical devices used in healthcare settings"
},
{
"regulation": "MDR",
"sector": "healthcare",
"subsector": "hospitals",
"applies": true,
"confidence": "definite",
"basis_article": "5",
"notes": "Health institutions using medical devices must ensure compliance"
},
{
"regulation": "MDR",
"sector": "manufacturing",
"subsector": "medical_devices",
"applies": true,
"confidence": "definite",
"basis_article": "2",
"notes": "Manufacturers of medical devices must obtain CE marking"
},
{
"regulation": "MDR",
"sector": "digital_infrastructure",
"subsector": "software",
"applies": true,
"confidence": "likely",
"basis_article": "2",
"notes": "Software as a Medical Device (SaMD) falls under MDR"
},
{
"regulation": "MDR",
"sector": "financial",
"subsector": null,
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "Financial sector not in scope of medical device regulation"
},
{
"regulation": "MDR",
"sector": "energy",
"subsector": null,
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "Energy sector not in scope"
},
{
"regulation": "MDR",
"sector": "transport",
"subsector": null,
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "Transport sector not in scope"
},
{
"regulation": "MDR",
"sector": "other",
"subsector": "importers_distributors",
"applies": true,
"confidence": "definite",
"basis_article": "2",
"notes": "Importers and distributors of medical devices have specific obligations"
}
]
