Europe
The Swiss Federal Office of Public Health, a division of the Federal Department of Home Affairs, has published an explanatory notice describing upcoming changes to the medical devices regulations. Regulatory Background The document provides additional clarifications...
EU MDR/IVDR
Swissmedic, the Swiss regulating authority in the sphere of medical devices, has published an official notice describing upcoming changes in applicable regulatory requirements. The announced changes related to the procedures to be performed when placing new medical...
Europe
Swissmedic, a Swiss authority responsible for medical device regulations, has published an information sheet dedicated to the marketing authorization of non-conforming medical devices. In particular, the document describes the rules and procedures to be applied for...
Europe
Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the...
Europe
The SwissMedic, the authority responsible for medical device regulations in Switzerland, has published, in coordination with the EU and MDR, updated regulations: new Medical Devices Ordinance (MedDO) and Clinical Trials for Medical Devices Ordinance (ClinO-MD). These...
Europe
Switzerland is going to amend its current medical device regulations in response to the changes implemented by Regulation 2017/745 (MDR). Mutual Recognition Agreement A mutual recognition agreement in the area of conformity assessment (MRA) is the most...
