Regulation 2017/746
/ˌrɛɡjʊˈleɪʃən tuːθaʊzənd ˈsɛvənˈtiːn slæʃ ˈsɪksˌfɔːrti sɪks/
Definitions
- (n.) A binding European Union regulation establishing the legal framework for in vitro diagnostic medical devices, enhancing safety and performance standards.
Regulation 2017/746 sets stringent requirements for manufacturers of in vitro diagnostic devices to ensure patient safety.
Forms
- regulation 2017/746
Related terms
See also
Commentary
Often cited simply as IVDR, this regulation is central for legal compliance in the EU health sector and replaces Directive 98/79/EC.
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.