Compliance/MDR/Healthtech
MDR compliance for Healthtech
Software intended to provide information for diagnostic or therapeutic decisions is Class IIa+ under Annex VIII rule 11. Triggers Art. 10 manufacturer obligations + Art. 83 post-market surveillance.
What applies
Articles + provisions of Regulation (EU) 2017/745 — Medical Device Regulation most directly engaged by Healthtech deployments:
- Annex VIII rule 11
- Art. 10
- Art. 83
What this looks like in Healthtech
Software intended to provide information for diagnostic or therapeutic decisions is Class IIa+ under Annex VIII rule 11. Triggers Art. 10 manufacturer obligations + Art. 83 post-market surveillance.
Flagship exampleClass IIa CDS notified-body conformity assessment: substrate-side handoff packet contributes to Annex II technical documentation.
Where Promethean's evidence layer fits
The substrate emits specific evidence kinds that map to MDR obligations. Most directly relevant for Healthtech:
For the full sector view including LLM-feature catalogue, tier recommendation, and reviewer-gate examples, see the Healthtech sector page.
Adjacent cells
Other regulations for Healthtech