EU MDR/IVDR
The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on further improving the regulations in the sphere of medical devices, has published a new visual guide describing the approach to be applied when determining whether...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR). Medical Software Regulated...
Europe
What is IVD/IVDR In Vitro Diagnostic (IVD) medical devices are intended for examining specimens of the human body to either provide information on the physiological state of the patient or to monitor therapeutic measures. They could also be used to define the...
