Today the EU Commission published a ‘Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices’
As expected, the EU Commission document confirms that European Single Market access ceases to apply for Switzerland IVD manufacturers as of the IVDR’s date of application: 26 May 2022.
The Notice outlines that Swiss IVD manufacturers will now be treated as any other third country manufacturer placing devices onto the EU market. This means that:
- Swiss manufacturers require an EU Authorized Representative.
- Swiss manufacturers must follow applicable EU legislation, including the requirements on registration and labelling of products. For more information read: Labeling requirements for EU, UK & Swiss In-Country Representative
- Notified Body certificates issued under the Swiss MRA, by Swiss Notified Bodies, will no longer be recognized as valid in Europe; CE marking certificates must be issued by an EU Notified Body.
For more information on Switzerland’s activities and requirements related to the IVDR, please read our Regulatory Update: Switzerland adopts IvDO/IVDR