Regulation 2017/745
/ˌrɛɡjʊˈleɪʃən tuː θaʊzənd ˈsɛvənˈti faɪv/
Definitions
- (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
Related terms
See also
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This regulation repealed and replaced earlier directives, notably Directive 93/42/EEC, harmonizing medical device laws across the EU with enhanced oversight and transparency.
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