Europe
The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...
Europe
The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published...
Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
COVID-19
The European Commission (EC) responsible for medical devices regulatory framework has published an official notice informing about its proposal to roll out the new In Vitro Diagnostic Medical Devices Regulation to ensure uninterrupted availability of vitally important...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the applicable classification rules. At the same time, the MDCG emphasizes that the document...
