All options must apply to you:

  1. A MD and/or IVD manufacturer?

  2. Located outside UK and EU?

  3. Selling to the UK and EU?

UK Responsible Person & 

EU Authorised Representative

UK Responsible Person and EU Authorised Representative

If you are a Medical Device and/or an In Vitro Diagnostic manufacturer, located outside of UK and EU, and selling to UK and EU, you will need to appoint both a UK Responsible Person and an EU Authorised Representative.

With offices based in Brighton, UK and Galway, Ireland, Psephos will take on the role of UK Responsible Person and EU Authorised Representative, providing you with legal and easy access to both geographies.

For more information on each of these roles, please refer to the UK Responsible Person page and to the EU Authorised Representative page.

Why appoint Psephos to be your UK Responsible Person and EU Authorised Representative?

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

  • Dedicated and supportive UK Responsible Person and EU Authorised Rep Department

  • 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 UK and 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.