EUDAMED Registration
Navigating the Complexities of EU Medical Device Registration
We specialise in facilitating EUDAMED registration for non-EU medical device manufacturers. As part of the EU’s regulatory framework, EUDAMED is essential for maintaining transparency, traceability, and market surveillance. We help you seamlessly navigate this mandatory database, ensuring your products comply with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Our team of qualified medical device representatives provides comprehensive services, from creating your EUDAMED account to submitting required documentation and maintaining compliance. With an in-depth understanding of the system, we simplify the registration process, allowing you to focus on product development and market expansion.
Key Benefits of Partnering with Aequum:
- Hassle-free EUDAMED registration and updates
- Monitoring regulatory changes and compliance needs
- Expertise in MDR and IVDR-specific submissions
- Real-time tracking of device data within EUDAMED
Our clients trust us to manage the intricacies of EUDAMED,
saving them time and ensuring uninterrupted access to the European market.