10/01/2024 | News release | Distributed by Public on 10/01/2024 02:56
Posted on 01.10.2024
Switzerland is situated at the heart of Europe and has a long standing economic, cultural and societal integration with the European Union. The EU is Switzerland's most important trading partner. For the EU, Switzerland is the fourth most important trading partner.
Since the Free Trade Agreement of 1972 between Switzerland and the EU, an increasingly dense network ofaround 20 main agreements in critical sectors including medical devices and in vitro diagnostic medical devices (IVDs) has been concluded in stages (Bilaterals I and II). On 26 May 2021, when the Swiss government broke off the negotiations for an institutional agreement intended to streamline and stabilize the numerous bilateral agreements, the EU declared the existing MRA (Mutual Recognition Agreement) for medical devices no longer applicable and downgraded Switzerland to a third country, effectively stopping the privileged trade in the area of medical devices with immediate effect. A similar situation has also been applying to IVDs as of 24 May 2022.
Swiss Medtech, SVDI and MedTech Europe, the Swiss and European medical technology industry associations, stand united behind the resumption of the EU-Switzerland negotiations in spring 2024 to secure an ambitious bilateral agreement («3rd bilateral package»). The update of the MRA in relation to conformity assessments for medical devices and IVDs is long overdue and should represent a key objective of the ongoing negotiations. It is in the mutual interest of Switzerland and the European Union: medical care for Swiss and European patients would be in a much better position with a timely adoption of an efficient, trade facilitating 3rd bilateral package.
For more information, please contact:
Miriam D'Ambrosio
Senior Manager Communications
MedTech Europe
[email protected]
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