Secure your place in the EU market with our foundational registration services. We assist economic operators (Manufacturers, Importers, System/Procedure Pack Producers) in establishing their official presence in EUDAMED.

• Actor Registration: We guide you through registering your organization to obtain your Single Registration Number (SRN), a prerequisite for all subsequent EUDAMED activities.
• Mandate Management: For non-EU manufacturers, we facilitate the verification process and act as your liaison to ensure valid Authorised Representative mandates are correctly recorded.
• Competent Authority Validation: Leveraging our regulatory expertise, we facilitate smoother and faster validation communications with Competent Authorities.

Managing Unique Device Identification (UDI) data is one of the biggest challenges under the MDR/IVDR. DDi provides both service-based and software-based solutions to handle your data efficiently.

• Device Data Submission: We support the upload of UDI and device data into the EUDAMED Device Module, ensuring strict adherence to the EU Commission’s user guides.
• Data Validation & Preparation: Our team validates your UDI device data against complex business rules before submission, minimizing rejection risks.
• Document Preparation: We review and prepare all necessary documentation to ensure your submitted information is fully compliant with MDR/IVDR requirements.

For organizations with large portfolios, manual entry is impossible. DDi offers advanced software tools to automate and streamline data exchange.

• M2M & Bulk Uploads: We provide Machine-to-Machine (M2M) data exchange solutions and bulk upload capabilities, allowing you to transfer large datasets directly to EUDAMED without manual input.
• XML Generation & Validation: Our software automatically converts your data into the required XML format and validates it against EUDAMED rules.
• Access Point Integration: We assist with eDelivery access point choices and build custom plug-ins to integrate your in-house applications (ERP/PLM) directly with EUDAMED.

Whether you need ad-hoc advice or a dedicated support partner, DDi is here to help.

• Strategic Consultancy: Expert advice on navigating the transition periods, legacy device rules, and regulatory deadlines.
• Incident Support: Dedicated support packages to resolve specific data errors or submission failures.
• Templates & Tools: Access to validated spreadsheet templates for MDR and IVDR data collection to ensure your internal data is “EUDAMED-ready”.