Swiss authorized representative (CH-REP)

As the Mutual Recognition Agreement between the EU and Switzerland has not been updated, the EU authorized representative cannot cover Switzerland with his mandate. If a product is to be marketable in Switzerland, the manufacturer is obliged to mandate a CH-REP.

Swiss AR Services has been offering this service as an independent partner since it came into force. This applies to both medical devices and in-vitro diagnostics.

Do you as an economic operator have questions about the implementation of the obligations? We are also happy to offer consulting services outside the mandate of the CH-REP.

Our strengths

High level of expertise as CH-REP:

• The employees have specialized in the topic and offer a top service with their experience.
• The high level of expertise is sometimes reflected in the processes optimized for you in order to relieve you.
• Thanks to the daily work in this function as well as internal and external training, employees are always up-to-date and keep an eye on future changes.
• A CH-REP employee is always available for you during office hours.

Swiss AR Services is in the lead:

• By taking on the mandate, we are also taking on a leading role. For us, it is not "just" a mandate. We live the duties.
• We create a project plan and monitor the tasks and timelines
• We guarantee the seamless marketability of your products on the market.

Joint "Issue Tracker" platform

• You will receive access to our issue tracker.
  You can view all open and completed tasks relating to the duties of the CH-REP at
  .
• You can see the status of the various measures in real time.

Cost transparency:

• The customer has a high level of cost transparency. Routine services
  are covered by our annual flat rates.

Swiss AR Services offers a helping hand:

• Are you the CH-REP and need a PRRC (Person Responsible for Regulatory Compliance)? We would be happy to support you with this too.
• Do you have questions about the obligations and rights of economic operators? We also offer consulting services. Our expertise will help you to obtain efficient answers and thus support.

Benefit from our experience and know-how to successfully position your products in Switzerland.

Any questions?

> FAQs Market Access