Switzerland: Updated MRA with the EU to Ease Market Access of Medical Devices
MedTech Europe and partner associations welcomed the EU–Switzerland agreement package, including the long-awaited update of the Mutual Recognition Agreement (MRA).
The revised MRA is expected to restore mutual acceptance of medical devices certified in the EU and Switzerland, eliminating duplicative regulatory procedures while maintaining high safety and quality standards.
The medical devices chapter had not been updated following the implementation of the EU Medical Device Regulation (MDR) in 2021, leading to increased administrative burden and parallel approval requirements for manufacturers.
According to industry representatives, the update will reduce regulatory duplication, improve supply chain efficiency and facilitate faster patient access to innovative medical technologies.
The associations indicated they will continue to support authorities during the ratification and implementation phase.
Source:
MedTech Europe: Press Release
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