EUDAMED & swissdamed Registration Support
Mandatory registration deadlines for EUDAMED and swissdamed are rapidly approaching. Manufacturers need a scalable, efficient strategy to meet staggered deadlines, shifting data requirements, and different workflows across databases. With a single, integrated platform and expert guidance, MedEnvoy’s Medical Device Registration Management (MDRM) service simplifies database compliance from initial registration through the life cycle of the device.
Why It’s Important to Register Early
Actor and Device registration in EUDAMED and swissdamed will become mandatory Q2 2026 in the EU and July 2026 in Switzerland, respectively. Early registration avoids bottlenecks and fees (Swissmedic fees begin July 2026). Depending on the number of devices (UDI-DIs) in your portfolio, it can take time to compile the required information. It’s important to organize now to avoid last-minute roadblocks and protect your access to EU and Swiss markets.
End-to-End Medical Device Registration Management
MedEnvoy supports device manufacturers with turnkey registration management built on regulatory expertise and a custom tech solution designed to make database registration as efficient and sustainable as possible.
How we can help:
Domain Expertise + Streamlined Execution
Our regulatory team brings decades of experience navigating EU and Swiss registration pathways. We ensure your data submissions meet the latest technical and legal requirements, including those under MDR Articles 29 and 31, and IVDR Articles 26 and 28.
A Single Platform for EU and Swiss Compliance
MedEnvoy leverages its proprietary Global Regulatory Information & Administration System (GloRIAS) to manage data collection, validation, and updates. This cloud-based platform simplifies collaboration and will support future connections with other regulatory databases, including FDA’s GUDID and TGA’s AusDID.
Full-service Device and Actor Registration
We manage your company and UDI-DI registrations, including:
- Guidance on company registration and SRN application in EUDAMED
- Actor registration through MedEnvoy’s CH-REP account in swissdamed (for non-Swiss manufacturers)
- UDI/Device registration uploads and updates across both systems
- Ongoing verification to ensure data consistency across platforms
Consistent Maintenance That Keeps You Compliant
Your EUDAMED and swissdamed registrations must be kept up-to-date to ensure compliance and market continuity. We provide ongoing support to maintain alignment between EUDAMED and swissdamed records, update existing registrations, and add new and remove discontinued devices.
Bundle EUDAMED + swissdamed for Cost-Effective Coverage
Clients using MedEnvoy as both their European Authorized Representative (EAR) and Swiss Authorized Representative (CH-REP) reduce cost and duplication by leveraging shared data collection and workflows across markets.
What to Expect from the Registration Process
Our registration workflow eliminates duplicate work using our intuitive, purpose-built platform:
- Kickoff and Data Collection: Structured onboarding through GloRIAS captures all required registration inputs.
- Review and Validation: Your dedicated Account Manager ensures all submissions are complete and properly formatted for regulatory approval.
- Submission and Follow-Up: We coordinate directly with Competent Authorities and Notified Bodies for a smooth submission process.
- Confirmation and Monitoring: Once registrations are confirmed, we track regulatory updates and keep your registration data current.
Actor and device registrations are typically completed within five business days after receiving complete and valid data. Review times by Competent Authorities or Notified Bodies can vary
Start Your EUDAMED and swissdamed Registration Today
MedEnvoy supports over 1,000 medical device and IVD manufacturers worldwide with expert regulatory and in-country representation services. Our MDRM offering integrates seamlessly with compliance activities to reduce your regulatory burden and get you to market faster.
