Swiss AR stands for Swiss Authorized Representative, also referred to as CH-REP. Medical device manufacturers located outside Switzerland and without any local business offices shall appoint a Swiss AR on their behalf as a prerequisite for device registration and to launch their device in Switzerland.
What is the legal basis for a Swiss AR?
Prerequisites to appoint a Swiss AR, roles of a Swiss AR, and other related information are defined in the Medical Devices Ordinance (MedDO) Art. 51.
When should a medical device manufacturer appoint a Swiss AR?
The device manufacturers with an intention to place their device in the Switzerland market shall appoint a Swiss AR before the device registration.
What are the roles and responsibilities of a Swiss AR?
- Must act on the foreign manufacturer’s behalf and register the devices with MedDO.
- Verify the declaration of conformity and the technical documentation.
- Verify if appropriate conformity assessment procedures have been carried out by the manufacturer.
- Verify that the manufacturer has complied with the registration obligations.
- Keep a copy of the technical documentation, the declaration of conformity, and the relevant certificate, along with any amendments and supplements.
- In response to a request from the competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a device in an official Union language determined by the concerned member state.
- Forward Swiss Medic requests for samples or access to a device, and ensure the Swiss Medic receives the said samples or is given access to the device.
- Cooperate with the Swiss Medic on any preventive or corrective action.
- Inform the manufacturer in a timely manner about complaints and reports received from the market.
Who can act as a Swiss AR?
Any third-party service provider, individual, or entity with a registered office in Switzerland can act as a Swiss AR on a foreign manufacturer’s behalf.
What are the timelines for appointing a Swiss AR?
The Swiss Medic has set lengthy transitional periods for the manufacturers to appoint authorized representatives. Below are the timelines for the foreign manufacturers to appoint a Swiss AR for varied risk classes of medical devices.
|Until December 31, 2021
||Until March 31, 2022
||Until July 31, 2022
- Class III devices
- Class IIb implantable devices, and
- Active implantable medical devices
- Non-implantable class IIb devices and class IIa devices
- Class I devices
- Systems and procedure packs
What are the prerequisites for acting as Swiss AR?
The authorized representative should register himself with the Swiss Medic and should have a Swiss Identification Number (CHRN). The Swiss AR should also have a registered office in Switzerland. The AR shall have one Person Responsible for Regulatory Compliance (PRRC) in the organization mandatorily, in addition, to a written mandate with the manufacturer.
What are the exemptions for appointing a Swiss AR?
Grace periods are applicable for EEA countries, including 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 with effect from May 26, 2021.
What are the Labeling Requirements in the Context of Swiss AR?
According to MedDO, the name and address of the Swiss AR must be stated on the packaging of the products. Stating the Swiss AR on the product, the instructions for use, or in documents enclosed with the product are not mandatory.
For more information on end-to-end Swiss AR services, reach us at email@example.com.