Since 2002, the Mutual Recognition Agreement (MRA) between the European Union and Switzerland has facilitated bilateral exchanges, particularly for medical devices. However, due to the political impasse surrounding the institutional framework agreement, the European Commission did not renew the MRA after May 26, 2021.
For European manufacturers, the Swiss Federal Council has implemented mitigating measures. Swiss regulations on medical devices have been adjusted to incorporate Regulation (EU) 2017/745. Certificates of conformity issued by EU notified bodies are unilaterally recognized until May 26, 2024.
However, European manufacturers must designate a Swiss authorized representative (CH-REP) and an importer, as well as update labeling. Swissmedic has established Swissdamed, a database equivalent to Eudamed, for necessary registrations.
For Swiss manufacturers wishing to export to the EU, the non-renewal of the MRA poses challenges. Swiss certificates are no longer recognized, requiring new certification by an EU notified body. Additionally, as Switzerland is now a “third country,” a European authorized representative must be designated, and registration in Eudamed is mandatory.
Finally, this non-renewal also affects manufacturers from third countries to the EU, obliging those with a Swiss authorized representative to designate a representative in the EU. The regulatory landscape for medical devices is evolving, prompting crucial adjustments for the involved stakeholders.
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