Europe – Questions Linger With Swiss-EU MRA and Device Regulation

The medical device association in Switzerland and two attorneys at Sidley Austin are raising questions about the mutual recognition agreement (MRA) between the EU and Switzerland and its impact on the trade of medical devices.

Following the changes coming with the EU’s Medical Devices Regulation (MDR), Switzerland is revising its own regulations.

On 26 May 2020, MDR will take effect and according to the regulator Swissmedic, the EU regulation is currently being transposed into Swiss law and “will be applicable in Switzerland through the revised Medical Devices Ordinance (MedDO) as of spring 2020.”

The changes mean that the EU and Switzerland must revise their MRA. And the EU is trying to link the completion of another agreement’s negotiations, which would streamline the harmonization of Swiss law with EU law, with its willingness to revise the MRA…