Themen

27 March 2020

The Agreement between Switzerland and the EU on mutual recognition in relation to conformity assessment (MRA) is part of the package of seven Bilateral I Agreements in place between Switzerland and the European Union. The MRA is an instrument for removing technical barriers to trade in the marketing of numerous industrial products between Switzerland and the EU. It applies to the most important product sectors (e.g. machinery, medical devices, electrical equipment, construction products). In terms of value, the agreement covers more than a quarter of all Swiss exports to the EU and more than a third of all imports of goods from the EU.

However, the MRA only represents a snapshot of the equivalence of sectoral legislation in Switzerland and the EU. It therefore requires continuous adaptation. For example, when revising their respective medical devices legislation, Switzerland and the EU continuously check that the legislation is still equivalent and, if needed, adapt Chapter 4 (which concerns medical device) of the Agreement.

The new EU legislation on medical devices (Medical Device Regulation, MDR), which is supposed to apply from May 26, 2020, will replace the current Medical Device Directive. The new MDR provides for additional obligations for economic operators, particularly with regard to the traceability of products after they have been placed on the market. Inter alia, the obligations regarding vigilance - i.e. monitoring the product and reporting incidents - have been strengthened. Further, the MDR lays down uniform and more stringent criteria for so-called notified bodies in the certification of medical devices and regulates the procedure for the approval of clinical trials of medical devices. Chapter 4 of the MRA needs be updated in order to reflect those changes. Also, the update necessary in order to maintain easier access for Swiss manufacturers to the EU market and to strengthen cooperation between the authorities of both parties so that Switzerland and the EU have efficient and uniform market surveillance.

So far, Switzerland and the EU have not been able to agree on an according revision of Chapter 4 of the MRA – thus  putting in danger the mutual recognition of medical devices, given the nearing deadline of May 26, 2020. The EU seems to be using the discontinuation of mutual recognition of medical devices as leverage to get Switzerland to sign an institutional framework agreement with the EU. 

In addition, the Commission has adopted decisions on harmonized standards to ensure, for example, the supply of medical face masks and disinfection equipment. Following an urgent appeal by the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in consultation with all their members, have made available a large number of European standards for certain medical devices and personal protective equipment. These standards should allow for a faster and cheaper conformity assessment procedure.

This may mean a temporary relief for Switzerland, buying it more time come to an agree-ment with the EU on the update of the MRA, and to focus on more pressing matters in light of the Corona outbreak. Also, at least for the time being, the EU will lose its leverage in connection with the ratification of the institutional framework agreement. However, this temporary postponement does not exempt Switzerland from reaching an agreement with the EU if it wants to avoid being treated as a "third country" under the MDR.

Our Life Sciences Team is happy to assist you.

Authors: Dr. Stefan Kohler, Ann Sofie Benz

Topics: Life SciencesMDRMedical Devices

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