Medical device CE marking

Status of the EU-Switzerland Mutual Recognition Agreement (MRA)


The European Union and Switzerland have not been able to update the existing MRA to cover the MDR. This means that Switzerland will become a “third country” as regards to medical devices (EU perspective). Devices on the EU market may no longer move freely to the Swiss market. Devices which will be put on the Swiss market have to comply with the Medical Device Ordinance (MedDO).

The European Commission has issued this guidance, it can be downloaded in our library
The Swiss Authorities have published this guidance: Link