The article provides an overview of the new guidance document issued by the MDCG about surveillance in the context of MDR transitional provisions. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
The second article addresses specific matters associated with the use of medical devices in healthcare institutions, including the obligations in the sphere of incident notification or direct import. Table of Contents Swissmedic, the country’s regulatory...
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...
The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
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...