EU MDR/IVDR SwissMedic, the Swiss regulating authority in the sphere of medical devices, has published a guidance document dedicated to the obligations of parties involved in operations with medical devices, other than manufacturers: authorized representatives, importers, and...
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...
Europe Swiss Medtech Group, the non-governmental association that represents the interests of the companies operating within the medtech industry, issued recommendations to medical device manufacturers covering issues related to gaining access to various markets within the...
