The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic ...

The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

IVDs are essential for disease detection, personalized treatment, and public health, driving growth in the global diagnostics ...