Acting as EU Authorised Representative, including mandate establishment, verification of technical documentation and Declaration of Conformity, and liaison with EU Competent Authorities.
We act as your EU Authorised Representative in accordance with MDR/IVDR, supporting non-EU manufacturers in placing and maintaining their medical devices on the European market. Through a formal mandate, we take on the required regulatory responsibilities and serve as your official point of contact with EU Competent Authorities.
Our role includes reviewing your Declaration of Conformity and confirming that technical documentation is in place and aligned with regulatory requirements. We ensure that key obligations are met prior to market access and remain fulfilled throughout the product lifecycle.
As your authorised representative, we maintain access to your technical documentation and support interactions with authorities, including handling regulatory queries and facilitating inspections when needed. We also verify that your registration obligations are met, including EUDAMED actor registration and device-related requirements where applicable.
In addition, we help ensure that your labelling complies with MDR/IVDR requirements, including the correct inclusion of authorised representative details. We also assist in coordinating post-market activities, such as incident reporting and communication with authorities.
Our Authorized Representative services include:
- Establishment of EU Authorised Representative mandate
- Verification of Declaration of Conformity and technical documentation availability
- Acting as official contact point with EU Competent Authorities
- Support with EUDAMED actor registration (SRN) and related obligations
- Maintenance of access to technical documentation for regulatory purposes
- Handling of regulatory enquiries and authority communications
- Verification of authorised representative labelling requirements
- Coordination of incident reporting and post-market communications
- Ongoing alignment with MDR/IVDR requirements
Your regulatory pathway, clearly defined
Share your requirements with us, and our team will reach out to arrange a meeting and prepare a tailored proposal for your regulatory needs.
Regulatory Liaison
Interface with EU Competent Authorities and Swissmedic, including management of regulatory queries, inspections, and formal communications.
EUDAMED Registrations
Management of Actor registration (SRN), UDI-DI and device registration within EUDAMED, ensuring accurate data submission, module alignment, and ongoing maintenance.
UDI & Traceability Management
Support with UDI strategy, Basic UDI-DI assignment, and implementation of traceability systems in line with MDR requirements.
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.
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
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.