Regulation (EU) 2023/607 provides for extended transition periods for legacy devices until 2027 or 2028 under certain conditions, depending on product classification. The Swiss federal department of home affairs is determined to incorporate the EU Regulation, adopted on 15 March, into Swiss law by amending the Medical Devices Ordinance and the Ordinance in In Vitro Diagnostic Medical Devices.
Switzerland has kept equivalency of its medical devices in Switzerland with that of the EU during the mutual recognition agreement and also after the failure to renew this agreement. The EU’s expanded transition times for legacy medical devices and IVD medical devices, and the removal of the pre-imposed legacy product sell-off deadlines (under both the MDR and IVDR) agreed to under the medical devices directives, will be reflected in Swiss legislation in autumn 2023 as per current schedule. In the meantime, Switzerland will permit devices that are covered by a valid certificate according to the MDR and IVDR amendments to be placed on their market, so that there will be no imbalance in market supply conditions between the EU and Switzerland.
Source: Medtech Insight (an Informa product)