The Mutual Recognition Agreement (MRA) between the EU and Switzerland established on 1st of June 2002 has facilitated market access and encouraged greater international harmonisation while protecting consumer safety.

A new MRA was – however – not established, with the date of application of the EU-MDR on May 26, 2021. Thus, the mutual recognition of certificates for medical devices had ended. Consequently, Switzerland was urged to draw-up a solution for preventing shortage of medical devices. Thus, a new Medical Device Ordinance (MedDO) was established, which in greater parts reflects the European legislation. However, Swiss specific topics need to be considered by manufacturers and other economic operators when marketing products in Switzerland.

The training will provide an overview of the Swiss MedDO covering topics to be considered when marketing medical devices in Switzerland versus the European Union.