In Vitro Diagnostic Regulation
/ɪn ˈvɪtroʊ ˌdaɪəɡˈnɒstɪk ˌrɛgjʊˈleɪʃən/
Definitions
- (n.) A regulatory framework governing the safety, performance, and clinical evaluation of in vitro diagnostic medical devices within certain jurisdictions, notably the European Union.
The In Vitro Diagnostic Regulation requires manufacturers to comply with stringent safety standards before market approval.
Forms
- in vitro diagnostic regulation
Related terms
See also
Commentary
The term is often abbreviated as IVDR in regulatory texts; it specifically addresses diagnostic tests performed outside the human body, a distinction important for classification and compliance requirements.
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.