Mutual Recognition Agreement Eu Schweiz

For most of the product sectors covered by the agreement, the technical rules of Switzerland and the EU are considered equivalent. The compliance assessments required for the internal market of the European Union can be carried out by a Swiss compliance assessment body recognised under the agreement and in accordance with Swiss technical rules. This applies to all products covered by the agreement, regardless of their origin. In the two product sectors where Swiss and EU legislation are not considered equivalent (hot water boilers and a certain category of measuring instruments), products to be exported to the EU must be manufactured in accordance with EU technical rules. However, the required compliance assessment may continue to be carried out by a Swiss compliance assessment body recognised as part of the agreement. The MRA with Israel is an agreement on the evaluation of compliance and acceptance of industrial products (ACAA). It is a specific type of MRI based on the alignment of the legal system and infrastructure of the country concerned with that of the EU. 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. 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. 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.

During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. The transition period for human-use medicines under the agreement ended on 11 July 2019: the Mutual Recognition Agreement (MRA) can be signed as part of this comprehensive agreement. Current guidelines on medical devices are covered by such agreements, but the MRA for the MDR can only be signed if there is an agreement on the broader contract.

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