Why GMDN and EMDN Codes Matter for Your Medical Devices
Legal background
Proper classification under GMDN and EMDN is not just a technical detail, it’s a regulatory requirement that directly impacts your ability to sell in the EU and globally. Without the correct GMDN codes or EMDN codes, your registration could be delayed, or worse, rejected, hindering your market access and compliance efforts.
These codes are essential because they:
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- EMDN is mandatory for EUDAMED device registration under MDR and IVDR.
- Facilitate communication with EU Competent Authorities for pre-market notifications.
- Support vigilance reporting and supply chain coordination across global markets.
- Ensure accurate regulatory documentation and product traceability.
- Are often required by Notified Bodies and importers as part of the conformity assessment.
Our services
Expert GMDN and EMDN Codes Research by Obelis
We offer complete support in identifying and assigning the correct GMDN and EMDN codes to your medical devices. Our team reviews your device’s intended use and specifications, researches the relevant terms within the GMDN paid-access database, and matches your product with the appropriate EMDN code from the EU’s public database. We ensure your nomenclature is accurate, aligned with MDR and IVDR requirements, and ready for EUDAMED registration or pre-market notifications. This strategic code selection not only supports traceability and regulatory compliance but also prevents costly delays during product approval and market access.
Avoid delays and rejections Obelis ensures your medical device is matched with the correct GMDN and EMDN codes from the start. Let our regulatory experts support your product’s successful path to compliance.
