1) CE marking medical devices
Manufacturers use the CE mark to place their equipment on the Swiss market. Swissmedic recognizes CE marking equipment and conventional equipment under the new regulations (MDR/IVDR), which are MDD/AIMDD/IVDD CE marking equipment in compliance with the transition period.
Manufacturers can use the European Notified Body to CE mark their equipment. A notified body headquartered in Switzerland is not required.
2) Appointment of a Swiss Authorized Representative (CH-REP)
Eu authorised representatives are not recognised in Switzerland. Instead, manufacturers must designate a Swiss Authorized Representative (AR), also known as CH-REP. Only one CH-REP is allowed per device family.
Manufacturers must enter into an agreement with Swiss AR, for which a Swiss authorized representative Agreement is provided to their customers.
3) The authorized Swiss representative must review the equipment information
The Swiss authorized representative is required to review the equipment documentation and ensure that the manufacturer follows the correct conformity assessment procedures.
To this end, the authorized Representative of Switzerland requests the following information:
CE Marking Certificate (if applicable)
ISO 13485 certificate (if applicable)
Signed Declaration of conformity - the EU version is sufficient, there is no need to create a Swiss version
Instructions for use
Copies of equipment and packaging labels
Basic Requirements List /GSPR list, whichever is applicable
Clinical evaluation report (or summary)
Risk management report (or summary)
Vigilance and post-market surveillance procedures
Post-market Surveillance (PMS) Plan - MDR/IVDR only, not required for MDD/AIMDD/IVDD CE marking devices
4) Add the Swiss authorized representative to the device label
Manufacturers must add Swiss authorized representatives to their labels in accordance with the following provisions:
MDR Class I: Before July 31, 2023 - in the label or file that comes with the device.
After July 31, 2023 - on the label.
MDR Classes IIa, IIb, III: On the label.
MDD: If already available before May 26, 2021 - in the label, instructions for use, or documentation that comes with the device. If new to the market after May 26, 2021 - on the label or in the instructions for use.
AIMDD: If already available before May 26, 2021 - on the sales package and instructions for use or accompanying documentation. If new to the market after May 26, 2021 - in the sales packaging and instructions for use.
IVDR self-test: On the label.
IVDR Non-self-test: Before March 31, 2025 - on the label or in the documentation that comes with the device. After March 31, 2025 - on the label.
IVDD: If it was available before May 26, 2022 - in the label packaging, instructions for use, or documentation accompanying the device. If placed on the market after May 26, 2022 - on the label, on the outer packaging or in the instructions for use.
Swissmedic publishes a CH-REP symbol that can be used.
Once the manufacturer has appointed a Swiss authorized representative and updated its label, they can start selling the device in Switzerland.
5) No medical device registration required - for now
Swissmedic only requires equipment registration for certain devices made by Swiss manufacturers.
Non-swiss manufacturers do not and should not register their devices with Swissmedic *. Please download the Swissmedic guidance document for medical device registration here.
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/meldung-medizinprodukten.html
However, Swissmedic is developing a new registration database that will be similar to the European Medical Device Database (EUDAMED). It's called Swissdamed and will launch in 2023. At that time, medical devices should be registered.
* The only exception is custom equipment, which should be registered regardless of where the manufacturer is located.
