Provision of Swiss Authorised Representative services under Swiss MedDO, including local representation, regulatory verification, and acting as the official contact point for Swissmedic.
We provide Swiss Authorised Representative (CH-REP) services in accordance with the Swiss Medical Devices Ordinance (MedDO), supporting non-Swiss manufacturers in placing and maintaining their medical devices on the Swiss market. Through a formal mandate, we act as your legal representative in Switzerland and ensure that all applicable regulatory obligations are met throughout the product lifecycle.
Our role includes verifying that your devices comply with Swiss regulatory requirements prior to market placement, including the availability of technical documentation and the EU Declaration of Conformity. We ensure that your devices are correctly registered with Swissmedic, where applicable, and that all economic operator obligations are fulfilled in line with national requirements.
As your CH-REP, we serve as the official contact point for Swissmedic and other relevant authorities, managing regulatory communications, responding to requests, and supporting inspections when required. We maintain access to your technical documentation and ensure that it can be made available to authorities upon request.
We also verify that labelling requirements specific to Switzerland are correctly implemented, including the identification of the Swiss Authorised Representative on device labelling and accompanying documentation. In addition, we support post-market obligations associated with the CH-REP role, including coordination of incident reporting and communication with Swiss authorities.
Our approach is practical and proactive, ensuring that your regulatory responsibilities in Switzerland are clearly managed and aligned with MedDO requirements, allowing you to focus on your core business activities.
Our representation services include:
- Establishment and maintenance of CH-REP mandate
- Verification of regulatory documentation and Declaration of Conformity
- Acting as official contact point with Swissmedic
- Support with Swissmedic registrations and economic operator obligations
- Maintenance of access to technical documentation
- Handling of regulatory enquiries and authority communications
- Verification of CH-REP labelling requirements
- Coordination of incident reporting and post-market communications
- Ongoing alignment with Swiss MedDO requirements
Appoint Your Swiss Authorised Representative
We act as your CH-REP, ensuring compliance with Swiss MedDO and serving as your official contact point with Swissmedic.
Swissmedic Registrations
Preparation and submission of device notifications and economic operator registrations with Swissmedic, ensuring compliance with national regulatory requirements for market access in Switzerland
Technical Documentation Review
Review and verification of technical documentation in accordance with MDR/IVDR, ensuring completeness, consistency, and readiness for regulatory scrutiny
Regulatory Liaison
Interface with EU Competent Authorities and Swissmedic, including management of regulatory queries, inspections, and formal communications.
Trusted Expertise
We work as an extension of your team, providing consistent communication, accountability, and long-term regulatory oversight throughout your product lifecycle.
Let’s work together
Discover how we support medical device manufacturers across the EU and Switzerland