Swiss Authorised Representative

All options must apply to you:

  1. A MD and/or IVD manufacturer?

  2. Located outside Switzerland?

  3. Selling to the Switzerland?

Swiss Authorised Representative

 

If you are a Medical Device and/or an In-Vitro Diagnostic manufacturer, located outside Switzerland, and selling to Switzerland, you will need to appoint a Swiss Authorised Representative.

With a registered place of business in Switzerland, Psephos can act as your Swiss Authorised Representative and be your point of contact between the manufacturer, the national Competent Authority and, as needed, Notified Bodies.

Swiss Authorised Representative

As a Swiss Authorised Representative, under the requirements of Article 51 of Medical Devices Ordinance SR 812.213 (MedDO), Psephos will: 

  • act as the primary point of contact with the Swiss Authorities;

  • assist with certain device registrations, as required;

  • be identified on product labelling in Switzerland; 

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

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

Why appoint Psephos to be your Swiss Authorised Representative?

  • Dedicated and supportive Authorised Representative 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 Switzerland

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