The annual fee for our service as CH-REP is CHF 1’500.00 per year, no matter how many products or what kind of Risk Class you have.
For review and approve of your products a one time fee for each product cathegory of for Risk Class I is CHF 1’600.00 and CHF 600.00 for all other Risk Classes.
No. Art.51 Par.1 of the MedDo as amended simply refers ot Art. 11 of the MDR. However, to be able to perform the tasks elaborated in that article, it is obvious that the Authorized Representative has to have in-house adequate experience and skills to perform the tasks. Were that not the case, the liability referred to in par. 5 of the MDR would be unsupportable.
After you submitted us the requested company and product documentation, it takes about 5 business days per product cathegory to review and approve the registration as CH-REP.
Your product don’t need to be certified as an MDR to register and sell them in Switzerland. With a valid MDD certificate or certification extension the CH-REP registration can still be done.
The CH-REP has to be on a labeling component that will be available to the end-user at the point of use, e.g. shelf box or sterile packaging, preferentially but not mandatorily on the device label. For products that are still certified under MDD, the CH REP may be on the IFU, if the IFU accompanies the product to the point-of-use, similar to the European Authorized Representative.