Orientation
The EU Health & Life-Sciences Legal Ecosystem — Map
A layered map of the instruments in this area and how they stack.
The EU health & life-sciences legal ecosystem
Work in progress. Structured stub. ⚠️ VERIFY markers are not settled facts.
| Layer | Question it answers | Main instruments |
|---|---|---|
| 1. Health data | How may health data be used and shared? | European Health Data Space (EHDS) |
| 2. Medical devices | How are devices placed on the market? | Medical Devices Regulation (MDR) |
| 3. Pharma | How are medicines authorised and regulated? | Pharmaceutical package (proposal / reform) |
| 4. Adjacent | AI in medical devices, product liability | See AI |
Sources
- EHDS — Regulation (EU) 2025/327 (EUR-Lex) ⚠️ VERIFY CELEX if citation drifts
- MDR — Regulation (EU) 2017/745 (EUR-Lex)