National MDR & IVDR Conference 2021
Swiss medtech is now a «third country»
With the coming into force of the new EU Medical Device Regulation (MDR) on 26 May 2021, the Swiss medtech industry has lost its previously barrier-free access to the EU internal market. You will find important information on export and import, offers of concrete assistance, and a selection of training seminars on the MDR portal. We also continuously feed the MDR portal with information from the authorities.
EU Commission Notice to Stakeholders
On 26 May 2021, the EU Commission published a statement for stakeholders on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices». They indicated that the mutual recognition and any associated facilitation of trade of medical devices between the EU and Switzerland ceases to apply as of 26 May 2021.
Responsibilities Switzerland: Mutual Recognition Agreement (MRA): SECO; Medical Devices Ordinance (MedDO): FOPH; Registration and market surveillance: swissmedic; Designating authority (DA) for Swiss designated bodies: swissmedic