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:

Search News & Events

  • Filter by category


Related news and events

NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

The European Union’s AI Act & its Impact on Medical Devices

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting