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Mutual Recognition Agreement Eu Schweiz

There is such an MRA between the EU and Switzerland that allows the market, without this verification, of the products in which the applicable legislation of Switzerland and the EU is considered equivalent. The same applies to medical devices controlled in Switzerland, since the European directives on medical devices have been transposed into Swiss legislation. The agreement ensures that Swiss manufacturers and compliance bodies for the products covered by the agreement have, as far as possible, the same access to the UNION market as their EU or EEA competitors. The MRA reduces the time and cost of placing products in foreign markets. The agreement helps to remove significant technical barriers to trade, on the one hand by confirming the harmonisation of the technical rules of Switzerland and the EU and, on the other hand, by making two compliance assessments redundant, since a compliance assessment is sufficient for access to the Swiss and EU markets. This assessment can be carried out by a compliance assessment body recognised in the agreement in accordance with the technical rules of Switzerland or the European Union. By appointing a compliance assessment body, the Swiss competent authority confirms that the agency meets the applicable technical requirements for assessing compliance. Accreditation may be a prerequisite for the designation (and recognition) of a compliance assessment agency. These agreements benefit regulators by reducing dual controls in any other area, allowing for a greater focus on sites likely to be at higher risk and increased coverage of global supply chain inspections. 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. 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. In these areas, EU legislation would apply in Switzerland, with the European Court of Justice having the final say. However, free movement was rejected by referendum and it has not yet been possible to find a compromise in the current draft agreement. The second reason is that they may not be fully aware of the consequences, given that the current MRA has recently been updated with respect to the guidelines to cover Chapter IV of the MDR. A representative of the Swiss government told Emergo that it was assumed that there would be no problem extending this MRA with the rest of the MDR.