Mutual Recognition Agreement (Mra) Switzerland

During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. The agreement between the Swiss Confederation and the European Community on mutual recognition in the context of the Compliance Assessment (MRA) came into force on 1 June 2002 as one of seven agreements concluded under a package known as the “Bilateral Agreement I”. The MRA is an instrument designed to remove technical barriers to trade in industrial goods between Switzerland and the EU. It applies to the main product sectors (including machinery. B, medical devices, electrical appliances, construction products, elevators, biocides). In value terms, the agreement covers about two thirds of trade in industrial products between Switzerland and the EU. Mutual recognition agreements are mutual recognition agreements for compliance assessment and are aimed in particular at removing trade barriers in state-regulated sectors. The EU and Switzerland have a TEL MRA which, in the product segments in which applicable Swiss legislation is considered an EU law, allows the assessment of compliance for the internal market of the European Union by a Swiss compliance assessment body recognised in accordance with Swiss technical rules, so that these products can be put on the EU market without further testing. These include medical devices tested in Switzerland, as EU directives on medical devices have been transposed into Swiss legislation. When the EU Medical Devices Regulation (MDR) comes into force, the previous directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) will no longer apply.

While Chapter 4 of Appendix 1 of the MRA between the EU and Switzerland refers to the MDR, this reference is only partial. The final implementation of the medical device regulations under way in Switzerland requires further revisions to the MRA. The EU-Swiss MRA was last updated on 22 December 2017. The outdated status of the EU-Swiss MRA creates legal uncertainty for medical devices in EU Member States and Switzerland. If the MRA is not updated, Swiss manufacturers of medical devices may be regulated as producers of third countries, so that medical devices imported from Switzerland are subject to import rules from third countries. As a result, distributors of Swiss medical devices in Member States may be considered “importers” within the meaning of the MDR, which would result in the imposition of additional (undesirable) requirements and liability risks. The export to Switzerland of aircraft manufactured in EU Member States would also be subject to new legal requirements. It therefore seems urgent that the MRA be updated and revised. However, negotiations on the update of the MRA have stalled in recent times, so it is not clear that the current legal situation with respect to the recognition of the MDR requirements will continue. Nevertheless, Switzerland is in the process of revising its legislation on medical devices on the basis of the new European provisions (for example.

B amendments to the Remedies Act (TPA), the Human Research Act (HRA) and the Medical Devices Regulation. A new regulation on in vitro diagnostics will follow in 2022. Distributors of Swiss medical devices, in particular, should closely monitor developments in order not to unwittingly assume the role of importer. reuschlaw will continue to monitor the MRA negotiations and will deal with them regularly in this newsletter. The issue of immigration was considered the most important point of this meeting. Switzerland is not part of the EU, but is linked to the Union through a series of agreements. There is, for example, a Mutual Recognition Agreement (MRA) that covers medical devices so that they can move them freely between the EU market and the Swiss market.

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