Swiss Access Market and designation of CH-REP explained.

CE-Marking

Completed EU CE Marking process allows to enter Swiss market.

Swissmedic (Swiss competent authority) accepts the EU Declaration of Conformity.

We review your product approval, and if required, we support you with completing CE-Marking process.

CH-REP designation

Non-Swiss Manufacturer must appoint the CH-REP to place its medical devices products on the Swiss market (Article 51 of the Medical Device Ordinance and article 44 of the In Vitro Diagnostic Devices (IvDO)).

The CH-REP (Authorized Representative (Swiss AR)) must be based in Switzerland.

ConsMed is willing to review your documentation per device/device group, and if it complies with MedDo/IvDo (the Swiss Medical Device (MedDO) or IVD (IvDO) Ordinances.) the contractually agreement with listed responsibilities, and if required further tasks, can be signed.

Since then you can use the Particulas of CH-REP (CH-REP logo with CH-REP data) on your labelling or in a document accompanying the device.

Registration/ Notification requirements

Only the Swiss Manufacturer, the Swiss Authorized Representatives (CH-REP), CH-Importer are obligated to register themselves with Swissmedic as Economic Operators. Once the registration is done, the CHRN (as SRN in EUDAMED) is issued.

Swiss Authorized Representatives (CH-REP) is notifying its Non-Swiss Manufacturer to Swissmedic and since then is acting on manufacturer’s behalf in Switzerland.

Registration of devices: Only custom-made device(s) must be registered with Swissmedic. The CH-REPs are not required to register another devices on behalf of the non-Swiss Manufacturers they represent.

CH-Importer

Appoint a Swiss-based importer (an EU Importer is not recognized in Switzerland).

Together, the particulars of CH-REP and CH- Importer (contact and address) must be present on the label of the medical devices placed on the market in Switzerland.

Place medical device and maintain compliance

Product information: For general sale of a medical device in Switzerland, the product information must be given in German, French and Italian. There are some exception for language requiremnts of product information.

Now the medical device is placed on Swiss market.

CH-REP will ensure proper compliance for your marketed product:

· notify you in case of vigilance,

· will report your trends to Swissmedic

· act on your behalf in Switzerland

· monitor for your devices any regulatory updates which might consider your product

· once you portfolio will increase/change, the CH-REP must be informed.

Do update your documentation with CH-REP particulars and Swiss Vigilance System.

Medical device registration in Switzerland