Switzerland has revised its Therapeutic Products Act (TPA), Medical Device Ordinance (MedDO), and In Vitro Diagnostic Devices Ordinance (IvDO) and aligned them with the European Medical Device Regulation (MDR), establishing legal equality with the EU MDR & IVDR. According to article 51 of the Medical Device Ordinance and article 44 of the In Vitro Diagnostic Devices (IvDO), a foreign manufacturer can only place their products on the Swiss market when they have delegated a person based in Switzerland as its Authorized Representative (Swiss AR).

A Swiss AR must be a natural or legal person based in Switzerland and must have received and accepted a written mandate from the manufacturer.

Foreign manufacturers may choose to designate multiple Swiss ARs for their device portfolio. However, there shall be only one Swiss AR for all devices of the same generic device group, and for different generic groups, multiple Swiss ARs can be appointed.

The Non-EU / EEA medical device manufacturers must appoint a Swiss AR effective from May 26, 2021. The EU / EEA medical device manufacturers must appoint their Swiss ARs within the transition period specified in the Medical Device Ordinance (MedDO) summarized below.
 

Device Classes	Grace Periods
Class III Devices, Class IIb Implantable Devices, all Active Implantable Medical Devices (AIMDs)	December 31, 2021
Non-Implantable Class IIb Devices, Class IIa Devices	March 31, 2022
Class I Devices, System, and Procedure Packs	July 31, 2022

The non-EU/EEA in vitro diagnostic device (IVD) manufacturers must appoint a Swiss AR effective from May 26, 2022. The EU/EEA IVD manufacturers must appoint the Swiss AR within the transition period mentioned in the In Vitro Diagnostic Devices Ordinance (IvDO) :-
 

Device Classes	Grace Periods
Class D	December 31, 2021
Class B & C	March 31, 2023
Class A	July 31, 2023

The grace periods are applicable for EEA countries including the Member States of the EU, Iceland, Norway, and Liechtenstein. Liechtenstein and Switzerland hold an active customs treaty, hence Liechtenstein is not obliged to designate a Swiss AR. All other foreign manufacturers must appoint a Swiss AR effective from May 26, 2021 (MedDO) and May 26, 2022 (IvDO).

A Swiss AR representing the foreign device manufacturer is responsible for the safety of the device products placed on the Swiss market. The Swiss AR must make sure to -

• Have access to technical documentation or contractually agree that the manufacturer, on request, submit the documentation directly to Swissmedic within seven (07) days
• Verify the device and check that declarations of conformity are available
• Be responsible for ensuring that the conformity assessment procedures have been carried out
• Verify that the manufacturer complies with registration obligations related to devices

• Report serious incidents and safety corrective actions in Switzerland to Swissmedic
• Be responsible for ensuring that reports are sent to Swissmedic
• Immediately forward the complaints and reports about suspected incidents to the manufacturer
• Must have details about data on post-market surveillance, registration of complaints, non-conforming devices, recalls, and withdrawals ("Complaints List")
• Must co-ordinate with Swissmedic for all the preventive or corrective actions
• Must retain a copy of Declarations of Conformity and certificates for 10 years after the last device was placed on the market. The retention period for implantable devices is 15 years

The product label must contain details of the Swiss AR. However, it is not mandatory to include the Swiss AR name in IFU or any documents related to a product or on the product itself. The product must include details of –

• Name of the Swiss AR
• The registered address of the Swiss AR
• Email address of the Swiss AR

The label should contain manufacturer details: the name of the manufacturer and the address of the registered place of business.

The company is subject to the obligations of both the Swiss AR and the importer. The company must register both as an importer and a Swiss AR and receive two Swiss Single Registration Number (CHRN).

Yes, companies can have different Swiss ARs for different products but must make sure that there is one Swiss AR for at least one generic device group.

Swissmedic has defined obligations for each of the economic operators – Swiss AR, distributor, and importer.

You can change your Swiss AR at any given time and a Swiss AR would notify Swissmedic about termination of services.

The critical steps include a mandate signed by the manufacturer and Swiss AR, a review of technical documents and registration with Swissmedic.

Detailed guidance on Swiss AR and their responsibilities is available at Swissmedic website

Yes, CE-marked products are valid to be placed on the Switzerland market and would require a Swiss AR.

There is no mandatory requirement, but the Swissmedic expects Swiss AR to process PMS activities and manufacturer responsibility. Since these obligations require defined process in place, the understanding is that the organization acting as Swiss AR would have basic QMS system.

A Swiss AR needs to be appointed even if the product is not CE-marked.

All classes of medical devices including active implantable medical devices and in-vitro diagnostic devices.

Swiss AR/ Switzerland based manufacturer will register the device on behalf of the manufacturer with Swissmedic.