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EU Must Up Pressure To Secure Swiss Device MRA Or Transitional Arrangements

Executive Summary

Patient care and device trade will suffer without urgent attention to the signing of the EU-Switzerland medtech mutual recognition agreement, say German health care products groups.

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A last-minute solution to the unresolved EU MRA issue is unlikely, so local manufacturers must prepare for Switzerland to be a “third country” to the EU after the MDR comes fully into force.

Swiss Referendum Outcome A Positive Step Toward Swiss/EU Future Trade Agreement

Detailed talks are still needed between the EU and Switzerland over the future of their mutual recognition agreement. But the biggest stumbling block has been removed.

EU/Swiss MRA (mutual recognition agreement) belatedly comes into force

The mutual recognition agreement (MRA) between Switzerland and the European Union in medical devices cam into force as Clinica to press. The MRA includes products covered by the EU's Active Implantable Medical Device Directive and the Medical Devices Directive. It does not yet include products covered by the In Vitro Diagnostics Directive, although details of amendments to allow for this have been exchanged between the two parties and informally agreed upon.

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