Following the lapse of the Mutual Recognition Agreement between the European Union and Switzerland, non-Swiss manufacturers are required to appoint a Swiss Authorised Representative (CH-REP) to place devices on the Swiss market.
Amstermed’s CH-REP service is delivered from Lausanne and covers registration with Swissmedic, CH-REP labelling obligations, and coordination with the Swiss vigilance system.
Transitional timelines for legacy devices, additional labelling requirements and importer notification are all managed under a single mandate.
Manufacturers established outside Switzerland placing medical devices on the Swiss market.
IVD manufacturers subject to the Swiss IvDO.
Manufacturers with legacy devices under transitional provisions requiring CH-REP appointment by the applicable deadline.
Notification of activities and devices to Swissmedic in accordance with Article 55 MepV.
Ensuring device labelling includes the name and address of the CH-REP as required.
Keeping a copy of the technical documentation, EU Declaration of Conformity and certificates at the disposal of Swissmedic.
Reporting serious incidents and field safety corrective actions to Swissmedic within statutory timelines.
Coordinating with Swiss importers to ensure their reporting obligations are met.
Structured termination and successor appointment procedures with Swissmedic notification.
Recognised Swiss office in the French-speaking region with proximity to the Bern authorities
Our internal infrastructure is Swiss-hosted, aligning with the CH-REP function.
CH-REP mandate coordinated with your EU AR to align labelling, vigilance and documentation.
Correspondence in English, French, German and Italian.
General and specialised medical devices
In-vitro diagnostics
Active implantable devices
Software as a Medical Device
Aesthetic devices covered by Annex XVI
Reusable surgical instruments
CH-REP obligations for non-Swiss manufacturers came into effect with transitional deadlines running through 2021 and 2022 depending on device class.
Yes. The CH-REP name and address must appear on device labelling or accompanying documentation for devices placed on the Swiss market.
Yes. One CH-REP mandate covers all devices of a manufacturer for the Swiss market.
Amstermed maintains both mandates under a common framework, so labelling, vigilance reports and technical documentation remain synchronised.
Amstermed applies the same standard process to every representation and consulting engagement, adapted to the requirements of the specific jurisdiction.
The process is designed to make regulatory obligations legible, auditable, and durable. Each stage produces documentation that becomes part of the permanent mandate record.
Written inquiry received via encrypted email or Threema. Scope and jurisdictions are outlined. A mutual non-disclosure agreement is executed.
Existing regulatory documentation is reviewed: Declaration of Conformity, certificates, quality management evidence, labelling, and technical file summary.
Amstermed regulatory reviewers assess device classification, applicable regulation, and any gaps against the requirements of the target jurisdiction.
A written mandate is drafted defining scope, term, retention obligations, termination and successor provisions, in accordance with the applicable regulation.
The mandate is executed by both parties. Amstermed formally accepts the appointment and coordinates the manufacturer's regulatory particulars.
Notification is made to the competent authority: EUDAMED, MHRA DORS, Swissmedic, TGA ARTG, or FDA registration and listing as applicable.
Where documentation is complete, the mandate can be executed within ten working days. Authority timelines are outside our control, but we can flag urgency where the framework permits.
Not for the mandate itself. Site audits may be required by Notified Bodies or authorities for the manufacturer, independent of the representation mandate.
Regulatory obligations for Swiss Authorised Representative (CH-REP) are set out in the primary framework above, complemented by guidance documents issued by the relevant competent authority and applicable delegated or implementing acts.
Full regulation in force for new devices placed on the market.
Legacy devices subject to conditional continued placement, subject to specified conditions.
All devices in scope must comply with the current framework.
Our regulatory expertise covers a broad spectrum of medical devices and in vitro diagnostic technologies. We support manufacturers across multiple product categories, providing tailored regulatory guidance, documentation, and compliance strategies that align with the specific requirements of each device type and target market.
Need a Swiss Representative for your products? Contact us to discuss compliant Swiss Representative services and receive expert guidance tailored to your regulatory requirements.