The Regulation on Medical Devices (MDR) and the In Vitro Diagnostics Regulation (IVDR), which will apply as of 2021 and 2022 respectively, regulate the development of innovative healthcare technologies and present significant challenges for all economic operators as well as for Swissmedic.
In an effort to recognise and address these challenges at an early stage, Swissmedic has established a Round Table on Medical Technology (RTMT) as a forum for multi-stakeholder dialogue.
This meeting aims to provide information concerning the planned regulatory changes and their implementation, notably relating to the introduction of the MDR and IVDR. It will also address the concerns of medical technology associations. It is hoped that the RTMT will become a regular occurrence in the long term, focusing on issues beyond the new regulations.
Further information on the goals of the RTMT and the scope and nature of collaboration can be found in the Terms of Reference (ToR).