CH REP
Swiss Authorized Representative (CH-REP)
for Medical Devices

Swiss Authorized Representative (CH-REP) for the Swiss Market

Who is a Swiss Authorized Representative (CH-REP) for Medical Devices?

A Swiss Authorized Representative (CH-REP) is any natural or legal person established in Switzerland who acts on behalf of a manufacturer to provide regulatory representation and support for placing medical devices on the Swiss market.
Although Switzerland has never been a member of the European Union, it has historically ensured market access through Mutual Recognition Agreements (MRAs) with the EU, facilitating the free movement of goods across borders.
With the entry into force of the EU Medical Device Regulation (MDR), no agreement was reached to renew the MRA covering medical devices. Despite Switzerland having aligned its Medical Device Ordinance (MedDO / MepV) closely with the MDR, the absence of an MRA resulted in Switzerland being considered an EU “third country”, similarly to the United Kingdom.
As a consequence, medical device and IVD manufacturers without a registered office in Switzerland are now required to appoint a Swiss Authorized Representative (CH-REP) and a Swiss importer in order to continue placing their products on the Swiss market.

Specialised Swiss Authorized Representative (CH-REP) for Medical Devices

Swiss Authorized Representative (CH-REP) Services for Medical Devices

As Swiss Authorized Representative (CH-REP), MDQ Services Ltd provides comprehensive regulatory support to medical device manufacturers, including:
  • Advising on and reviewing labelling updates to ensure compliance with the Swiss Medical Devices Ordinance (MedDO / MepV);
  • Review of labelling and accompanying information, including Instructions for Use (IFU), to verify regulatory conformity;
  • Verification of the Declaration of Conformity and availability of technical documentation;
  • Verification that the appropriate conformity assessment procedure has been correctly applied;
  • Verification that a UDI has been correctly assigned, where applicable;
  • Verification of correct manufacturer identification on the device and accompanying documentation;
  • Verification that storage and transportation conditions comply with applicable regulatory requirements;
  • Ensuring compliance with supervision, vigilance, and incident reporting obligations applicable to Swiss Authorized Representatives;
  • Maintaining a complaint log, as required by Swiss law;
  • Immediate notification to the manufacturer in the event that a device presents a serious risk or non-compliance;
  • Verification of device registration with Swissmedic, where required;
  • Reporting serious incidents and safety risks to Swissmedic, in accordance with legal obligations;
  • Cooperation with Swissmedic on any required preventive or corrective actions;
  • Verification of device identification and traceability within the supply chain.
MDQ Services Ltd provides Swiss Authorized Representative services tailored to the specific regulatory and operational needs of each manufacturer, ensuring continued compliance and uninterrupted access to the Swiss market.

Deadlines for Appointing a Swiss Authorized Representative (CH-REP)

Deadlines for Appointing a Swiss Authorized Representative (CH-REP)
The deadlines for the appointment of a Swiss Authorized Representative (CH-REP) are defined according to the device risk class, as outlined below:
  • Class III, Class IIb, and active implantable medical devices:
Swiss Authorized Representative required by 31 December 2021
  • Class IIa and Class IIb non-implantable devices:
Swiss Authorized Representative required by 31 March 2022
  • Class I medical devices and procedural systems / kits:
Swiss Authorized Representative required by 31 July 2022

BOOK NOW

MDQ’s Swiss Authorized Representative (CH-REP) 
Are Designed to Be:

Tailored

The CH-REP service is provided under an annual service fee, reflecting the regulatory responsibilities associated with the appointment as Swiss Authorized Representative.
Fees are structured according to the number of product families.
All activities are clearly defined and detailed in a transparent and accurate quotation.

Performance driven

We support post-market surveillance and vigilance activities, including performance monitoring, incident management, and regulatory reporting in Switzerland.
Our team understands the importance of data-driven oversight and knows how to access, assess, and interpret regulatory and clinical information to ensure ongoing compliance with Swiss requirements.

Fully Compliant

One of our qualified regulatory engineers oversees the conformity of your medical devices.
Device compliance is systematically verified in accordance with the Swiss Medical Devices Ordinance (MedDO / MepV) and Swissmedic requirements, ensuring robust and reliable regulatory oversight.

Looking for a Swiss Authorized Representative (CH-REP) for your medical devices?
We’re here to help!

We take the time to fully understand your specific needs, enabling us to deliver the most appropriate solution.
Tell us what you are looking for, and our team will be pleased to support you.
CONTACT US