Preparation and submission of device notifications and economic operator registrations with Swissmedic, ensuring compliance with national regulatory requirements for market access in Switzerland.
We support medical device manufacturers in fulfilling Swissmedic registration and notification requirements in accordance with the Swiss Medical Devices Ordinance (MedDO). Our services ensure that both manufacturers and devices are correctly registered, allowing compliant placement of products on the Swiss market.
Swiss requirements differ from the EU framework and include specific obligations for economic operators and device notifications. We guide you through these requirements, ensuring that your company is properly registered with Swissmedic and that all relevant device information is submitted accurately.
We support the registration of Swiss Authorised Representatives (CH-REP), importers, and manufacturers, as applicable, and ensure that all required data is aligned with Swissmedic expectations. For device notifications, we prepare and submit the necessary information, including device details, classification, and relevant regulatory documentation.
We also ensure consistency between Swiss and EU regulatory data, particularly where devices are already registered in EUDAMED, helping you maintain a coherent and compliant regulatory framework across both jurisdictions.
Our approach includes managing submissions, supporting responses to Swissmedic queries, and ensuring that registration data is kept up to date as products or regulatory requirements evolve.
Our services include:
- Registration of economic operators (CH-REP, importers, manufacturers) with Swissmedic
- Preparation and submission of device notifications in accordance with MedDO
- Verification of device classification and regulatory documentation
- Alignment of Swissmedic data with EU regulatory information
- Support with Swissmedic queries and authority communications
- Maintenance and updates of registration and notification data
Simplify Swiss Market Registration
We manage Swissmedic notifications and registration requirements, ensuring your devices meet all national obligations for market access.
Swiss Authorised Representation
Provision of Swiss Authorised Representative services under Swiss MedDO, including local representation, regulatory verification, and acting as the official contact point for Swissmedic.
Regulatory Liaison
Interface with EU Competent Authorities and Swissmedic, including management of regulatory queries, inspections, and formal communications.
Technical Documentation Review
Review and verification of technical documentation in accordance with MDR/IVDR, ensuring completeness, consistency, and readiness for regulatory scrutiny
Let’s work together
Discover how we support medical device manufacturers across the EU and Switzerland
Trusted Expertise
We work as an extension of your team, providing consistent communication, accountability, and long-term regulatory oversight throughout your product lifecycle.