With the introduction of the new EU medical device regulation (MDR 2017/745), access to the EU market for third countries is only available via a authorized representative based in the EU area who represents the manufacturer.
In case of non-renewal of the EU Framework Agreement, Swiss manufacturers will also have to comply with third country requirements in the future.
AXXOS GmbH may act as an Authorized Representative and ensures your EU market access
AXXOS GmbH is an established consulting company with headquarter based in Switzerland. We support our long-standing clients in medical technology and pharmaceuticals in all aspects of registration, product conformity and quality management. This expertise makes AXXOS GmbH a strong partner as your EU representative.
Review and administration of the declaration of conformity and the technical documentation according to the latest requirements (MDR)
- Registration of the products in the EU database
- Primary contact with EU authorities (e.g. for sample requests, auditing)
- Market Vigilance Report: reporting and advice in case of product incidents
- Market Insights: Trend updates on EU market regulation