All options must apply to you:

  1. A MD and/or IVD manufacturer?

  2. Located outside EU?

  3. Selling to the EU?

EU Authorised Representative

EU Authorised Representative

The European Union (EU) requires any manufacturer not based in EU who intends to sell their devices in any of the EU Member States (including EFTA - Iceland, Liechtenstein, Norway and Switzerland) to designate a European Authorised Representative (EUAR). Since the UK’s departure from the EU this requirement now applies to all UK-based manufacturers.

With a registered place of business in Ireland, can act as your EUAR and be your point of contact between the manufacturer, the national Competent Authorities and, as needed, Notified Bodies.

As an EU Authorised Representative, under the Medical Devices Regulation (2017/745/EU) (MDR) from 26th May 2021, Psephos will:

  • act as the primary point of contact for the EU Authorities;

  • assist with certain device registrations (e.g. EUDAMED), as required;

  • be identified on product labelling throughout Europe; 

  • keep a copy of the technical documentation ready and available for inspection by a Competent Authority, upon request;

  • assist with Incident and Field Safety Corrective Action (FSCA) reporting, as required. 

Why appoint Psephos to be your EU Authorised Representative?

  • 20+ years of experience working with clients helping them place their devices on the global market, liaising with the relevant Competent Authorities and Notified Bodies, in different jurisdictions

  • Dedicated and supportive European Authorised Representative consultants

  • Independent consultancy with no conflict of interest

  • Quotations are bespoke with no unexpected or hidden fees

  • Insurance to cover liability

  • Registered place of business in Galway, EU

 

When you get in touch with us you will be asked to confirm the number of devices that you would like to register, and how many technical files that would involve. Once we receive this information, we will provide you with a tailored quotation and support you with any questions that you may have. 

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