Swissmedic: Equivalence with New EU MDR/IVDR Timelines

The Swiss Federal Council intends to grant an extended period for the certification of medical devices in accordance with the extension of the corresponding EU regulation (we reported). This will require an amendment of the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The revision of the two ordinances is planned for autumn 2023.

During the transition phase, Swissmedic is already implementing enforcement in accordance with the EU amendment, so as not to jeopardise the supply of medical devices in Switzerland. Until then, Swissmedic will tolerate the placement of devices on the market in Switzerland which are covered by a valid certificate according to the MDR and IVDR amendments. Anticipating the adjustment of the regulation within the framework of enforcement practice prevents different requirements for market supply between Switzerland and the EU and ensures legal certainty during the transition phase. This measure ensures that products that are marketable in the EU remain available for Swiss patients. Thus, with immediate effect, the issuing of confirmation letters in accordance with the EU position paper MDCG 2022-18 is also unnecessary in Switzerland.

Swissmedic will base its enforcement on the relevant EU interpretation documents.

Source:

Swissmedic: MDR/IVDR amendment