Regulation 2017/745

/ˌrɛɡjʊˈleɪʃən tuː θaʊzənd ˈsɛvənˈti faɪv/

Definitions

  1. (n.) A European Union regulation establishing the legal framework for medical devices, enforcing safety, performance, and marketing requirements.
    Regulation 2017/745 ensures all medical devices in the EU meet stringent safety standards.

Forms

  • regulation 2017/745

Commentary

This regulation repealed and replaced earlier directives, notably Directive 93/42/EEC, harmonizing medical device laws across the EU with enhanced oversight and transparency.

This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.

Draft confidently with Amicus

Create, negotiate, and sign agreements in one secure workspace—invite collaborators, track revisions, and keep audit-ready records automatically.

Open the Amicus app