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Medical devices: Will Switzerland end up outside the common market?

Company: Vilímková Dudák & Partners

Switzerland's position on the European medical devices market is starting to deteriorate considerably. Will it end up outside the common market in the field of medical devices after MDR is effective?

Switzerland is not a member of the European Union and the presence of Swiss medical devices in the European common market is made possible by the Agreement between the European Community and the Swiss Confederation on Mutual Recognition of Conformity Assessment (MRA). This MRA is part of a package of 7 bilateral sectoral agreements covering 7 core areas of cooperation between the EU and Switzerland (free movement of persons, air transport, road transport, agriculture, technical barriers to trade (covered by the aforementioned MRA), public procurement and science and research).

Each sectoral agreement explicitly states which legislative instruments on each party are covered by the MRA. In the event that there is a change in legislation on the part of the EU or Switzerland, it is always necessary to change the relevant text in individual agreements by an amendment to the international treaty. This process has proved to be quite impractical over time, and since 2014 the EU has been trying to negotiate an Institutional Framework Agreement (InstA) with Switzerland to remove the need for constant updates. InstA therefore aims to introduce a mechanism that will take into account developments in EU legislation in particular, while maintaining safeguards in Switzerland in the form of referendums on individual cases (i.e. the adoption of European legislation by Switzerland will not be fully automatic even under InstA).

Negotiations on a new form of cooperation have stalled due to the Swiss public's opposition to other parts of the agreement (notably the free movement of persons). Commissioner for European Neighbourhood Policy and Enlargement Negotiations Johannes Hahn said more than a year ago that no existing agreements guaranteeing Switzerland's access to the common market will be updated until the issue of adopting an institutional framework agreement is resolved. . 

Switzerland is preparing to adopt the Medical Devices Regulation (EU2017 / 745, Official Journal L 117, 5.5.2017, p. 1–175 MDR) by amending the Swiss Medical Devices Regulation (MedDO, RO 812.213). For Switzerland, however, the decisive factor is that the MRA mentions as equivalent in the field of medical devices only the previous Swiss Medical Devices Regulation (RO 2001 3487), as last amended on 25 October 2017 (RO 2017 5935)) and the European Medical Devices Directive 93/42 EEC and Implantable Medical Devices Directive 90/385 EEC (and several other sub-directives) and from the Medical Devices Regulation (EU 2017/745; MDR) only Chapter IV and Annex VII (concerning notified bodies). Thus, Swiss medical devices will only be able to be placed on the market until the MDR is effective, since, at the same time as the MDR comes into force, all the above instruments are essentially repealed. If there is no significant progress in the next three months, Swiss medical devices will have to be treated as if they were produced in third countries. Swiss medical devices will therefore be regarded as not equivalent to products manufactured in the EU.

Swiss Association of Manufacturers of Medical Devices (Swiss Medtech) is aware of the precarious situation. In December last year (2019), Swiss Medtech announced that the position of third country products would only relate to MDR-compliant products. In the meantime, however, the European Commission prevailed that this was not the case. Swiss Medtech released a statement at the end of January, which warns Swiss medical device manufacturers that from May 2020, if there is no agreement between the EU and Switzerland, the "worst case scenario" happens. Thus, no Swiss medical devices will be covered by the MRA. This means that all new products placed on the market (each individual piece, not only under MDR but also under existing legislation under the transitional period) will have the status of products from third countries, with all the consequences for manufacturers (in particular the obligation to remove the CE marking from the device, designate an authorized representative, modify the packaging, etc.). This will be a very significant hit for the Swiss medical devices sector and hence for the whole of Switzerland, as MedTech's industry revenue amounts to CHF 15.8 billion, accounting for 2.3% of Swiss GDP, while nearly 50% of revenues from medical devices are exports to EU countries.

Tags: Law | Health |

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