Swiss Authorized Representative

Your passport to medical device and IVD market access in Switzerland.

Switzerland no longer has a mutual agreement with the EU. As a result, all medical device manufacturers wanting to keep or place their products on the Swiss market are required to appoint a Swiss legal representative.

We offer a highly compliant and professional service that helps manufacturers bring products successfully to the Swiss market.

Our clear and simple approach:

Step 1: Verification
After signing an NDA, we will ask you for access to high-level documentation to verify whether it is feasible for us to be your representative. For this we request the following documents:

  • Early determination of clinical development plan for global market access
  • CE certificate and ISO 13485 certificate
  • Your product liability insurance policy
  • A risk management file, clinical evaluation file (including PMS/PMCF plan/reports), IFU, and labeling of a representative product or product group
  • Your SOP on the authorized representative process

Upon validation of verification, we will provide you with our standard agreement.

Step 2: Before getting started
We will need proof of an updated product liability insurance policy covering MD-CLINICALS as an authorized representative. This is an important step as we will be taking local responsibility for your product on the Swiss market.

Step 3: Signing and getting started
After receiving the final insurance policy, MD-CLINICALS will countersign the agreement and we are then ready to get started. You will receive our local registration number for adapting your labeling. We will proceed with a full review of your file before registering your product with Swissmedic. For this, we will provide you with secured access to a local server where you can provide us with up-to-date documents from your product technical file.

After a review of the appropriate documents in your technical file, we will proceed with the registration of your product(s) in the Swiss medical device database.

For further inquiry, please contact

Contact us for a free half-hour consultation