There are more than 120 MRA with a broader framework agreement. In 2014, Switzerland and the EU began negotiating a new institutional framework agreement (“InstA”), which resulted in a proposal in 2018. InstA is sometimes referred to as the “EEA light” because it contains many elements that are currently included in the EEA, but without a central control body. At the end of 2018, however, the Swiss rejected this proposal in a public consultation. The main reason for this was the immigration of EU citizens. The rejection was fuelled by the right-wing Swiss party, the UDC, which claimed that these immigrants would deprive Swiss people of jobs and benefit from Swiss social security. As InstA has been rejected, it is not possible to sign new MRAs. This means that the issue of immigration goes well beyond the other as allowing the free movement of people; Swiss stock exchanges no longer have direct access to EU markets and the medical device industry is now seeing the consequences of this vote, as the MDR is not covered by a signed MRA. A Mutual Recognition Agreement in the Field of Compliance Assessment (MRA) is the most important document to define the principles needed to interconnect Swiss and EU markets. MMAs aim to reduce delays and costs of access to foreign markets for many categories of industrial products, including medical devices.

The Chapters of Appendix 1 are systematically divided into five sections. They list the legislation, legislation and regulations in force in the product sectors and define the scope of the agreement. The chapters also contain certain sectoral provisions, such as information exchange, market surveillance cooperation. It is also important to mention that due to effective attempts at harmonisation, most of the rules in Switzerland and the EU are so similar that certificates issued in accordance with Switzerland`s requirements often allow the device to be marketed in the EU. In essence, the agreement contains general rules that apply to all categories of industrial products within the scope of the regulation.