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SERVICES | EU Authorised Representative

December 13, 2023

Looking for a trusted partner to help you comply with the European regulations for Medical Devices and IVD?

Asphalion is committed to guiding you through every step of the process, ensuring efficient communication, confidentiality, full lifecycle support, and cost-effective solutions.

As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD:

  • Contact point with EU Competent Authorities and Notified Bodies
  • Support with Medical Device and IVDs registrations, as required
  • Keeping Technical Documentation and Declaration of conformity available upon Health Authorities request
  • Regulatory intelligence: stay always up to date on legislation changes and how they can affect your products


Check out all the services we can offer you and how we can adapt them to your project:

For further information you can contect us at: [email protected]

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Achieving CE Marking is crucial for medical devices intended for the European market. Asphalion MedTech, a specialized unit within Asphalion, provides comprehensive guidance and expert

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