Global harmonisation in definition and classification of IVDs
Committee:
IVD (In Vitro Diagnostics)status:
Good progress
Published:
Discussions are underway regarding the classification and definition of IVDs under the Pharmaceutical and Medical Device Act in preparation for the revision of the Law.
Recommendations
- EBC requests proper regulations for classification (currently classified under Pharma) and definitions/scopes, based on the special characteristics of IVDs.