The CH-REP Icon: An introduction to the Swiss certification of medical devices and personal protective equipment

Have you ever noticed that there is a CH-REP symbol on our box? In this blog entry, we explain what it stands for and why PPE products must have this symbol on their packaging.

The Medical Devices Ordinance (MedDO) and the In Vitro Diagnostics Ordinance (IvDO) of Swissmedic require all foreign (non-Swiss) manufacturers of medical devices to appoint a Swiss-authorised representative to place their products on the Swiss market. Manufacturers based outside Switzerland must appoint a Swiss authorised representative (CH-REP) before they can place their products on the Swiss market.

The responsibilities of the Swiss Authorised Representative are similar to those of the European Authorised Representative. This is because there was an agreement between Switzerland and the EU on the mutual recognition of medical devices until 2021.

The Swiss Medical Devices Ordinance (MedDO/IvDO) was amended to comply with the MDR/IVDR in anticipation of dissolving the expired MRA and eventually returning to the European single market. It, therefore, refers to Article 11 of the MDR/IVDR (authorised representative) as the requirements that the Swiss AR must fulfil.

The symbol CH REP must be used to identify the Swiss authorised representative and must appear on the packaging and label of the medical device. The name and address of the authorised representative must be indicated in proximity to the symbol.

What are the obligations of the CH-REP?

• To maintain a registered place of business in Switzerland or Liechtenstein;
• To establish the Swiss mandate for each manufacturer, they represent;
• To appoint a person responsible for compliance
• To ensure that the manufacturer has carried out the appropriate conformity assessment process and prepared the relevant technical documentation;
• To have access to the technical documentation in the event of a request from Swissmedic;
• To be the contact person between the manufacturer and Swissmedic, if required;
• To assist with vigilance enquiries, including notifying the manufacturer of any complaints or reported events and coordinating vigilance notifications to Swissmedic.

Does the Swiss authorised representative have to be indicated on the labelling?

Yes, the Swiss authorised representative must be indicated on the product labelling (or on the accompanying document for certain products).

Swissmedic has approved a CH-REP symbol for use, which is similar in design to the EC-REP symbol. Minimum size is not defined, except that it must be clearly legible to the naked eye. The CH-REP logo is available in various formats.

In summary, the CH-REP symbol is mandatory for certain PPE products under Swiss regulations. The symbol indicates that a Swiss representative has been appointed to ensure compliance with Swiss regulations and to act as a contact person between the manufacturer and Swissmedic. It is important that medical device manufacturers are aware of the responsibilities of the CH-REP representative and ensure that the CH-REP symbol is properly displayed on their product packaging and labels.

For more information on PPE certifications, see our Guidelines page.

Do you still have questions about this topic? Contact our team!