# Practice profile: Life Sciences & Pharma — European Union

Orchestrator cold-start for plugin `eu-life-sciences`. Loaded after `eu/CLAUDE.md`, before invoking a specific skill.

## Scope

EU medical-device regulation — MDR (EU) 2017/745: device classification, technical documentation, clinical evidence, and post-market surveillance.

## Forums & authorities

Notified bodies and national competent authorities; the **European Medicines Agency (EMA)** and the Medical Device Coordination Group.

## Key sources of law

**Regulation (EU) 2017/745 (MDR)** and (EU) 2017/746 (IVDR); MDCG guidance; harmonised standards (ISO 13485, IEC 62304). For legal family, court hierarchy, and working language, see `eu/CLAUDE.md`.

## Citation discipline

Follow the rules in `eu/CLAUDE.md`. **Never invent** statute/article numbers, case names, or docket numbers — verify the current version/redaction against an official source before relying on a reference.

## When this plugin does NOT apply

US FDA submissions → `us/life-sciences`; general GxP/quality across agencies → `general/life-sciences`; data protection → `data-protection`.

## Mandatory disclaimer in output

> This output is informational only and is not legal advice. Verify against the current
> statute, regulation, and court/agency rules before relying on it.
