Swiss Mutual Recognition Agreement likely not updated by May 26 2021 ⏳

SWISS MEDTECH has announced that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union will probably not be updated by May 26th, creating uncertainty.

📢 Key Quote

(1)    "On 26 May 2021 the European Medical Device Regulation (MDR) will come into force, the same day that the corresponding Swiss Medical Device Ordinance (MedDO) enters into effect. All stakeholders must be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will probably not be updated by 26 May 2021.It is also legally uncertain how the currently valid MRA of December 2017 will be interpreted by the EU Commission as of 26 May 2021."

📚 Documents

Published by SWISS MEDTECH, useful documents for distributers, importers and manufacturers.

·         Importing Medical Devices to Switzerland - https://bit.ly/2QWVgQ5

·         Importers and Distributors Guidance - https://bit.ly/2QNIpiN

·         Swiss Manufacturers Guidance (in German) - https://bit.ly/3m4WunE