Although the EU does not assume that there will be major disruptions in the health sector during the current COVID-19 pandemic, it proposed to Switzerland on March 30th as a precautionary measure a limited amendment to the agreement on mutual recognition, thus applying to existing Swiss certificates of conformity Transitional period until (at most) May 26, 2024 is granted, during which existing certificates issued in the EU remain valid. Despite ongoing efforts and the EU’s willingness to conclude such a transitional arrangement, the proposed change was not agreed until May 26, 2021. Until a potential agreement is reached on the proposed amendment to the MRA, the trade facilitations of the MRA for medical devices, such as the mutual recognition of the results of the conformity assessment, the waiver of an authorized representative and the alignment of technical regulations, will no longer apply from May 26, 2021.
The Mutual Recognition Agreement (MRA) is one of the most important agreements between the EU and Switzerland that facilitates bilateral trade in a number of key areas. This is essentially an agreement on “access to the internal market” and “dynamic alignment” with EU regulations – two principles that are at the center of the institutional framework agreement that has been negotiated with Switzerland since 2014. The MRA therefore falls within the scope of the institutional framework agreement between the EU and Switzerland. Basically, it is about the issue of a level playing field.
Against this background, the EU has always made it clear that without an agreement on the institutional framework agreement, an update of the MRA, including the chapter on medical devices, cannot be considered.
Switzerland exports 46 percent of its medical products to the EU and imports 54 percent from the EU. In comparison: the EU imports 10 percent of medical devices from Switzerland and only 5 percent of medical devices to Switzerland.
Additional Information:
Full press release
Communication to stakeholders
Factsheet: What if no agreement is reached on the institutional framework agreement?
Press contacts: Claudia Guske, Tel .: +49 (30) 2280-2190
The team at the ERLEBNIS EUROPA visitor center answers questions from citizens by e-mail or by telephone on (030) 2280 2900.
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