Key Takeaways
- Manufacturers must register early to avoid compliance issues.
- Notified Bodies face stricter deadlines for certificate submissions.
- Failure to register devices within the stipulated timeframe could result in market restrictions.
- Ongoing development of the Post-Market Surveillance and Clinical
- Investigations modules indicates future compliance requirements.
The European Commission has finalized the Questions and Answers (Q&A) on EUDAMED, outlining the mandatory deadlines for various modules essential to the regulation of medical devices within the EU. This move follows the recent Amendment (EU) 2024/1860, aiming to streamline the compliance process for manufacturers, Notified Bodies, and other stakeholders.
Article 34 MDR has been revised to facilitate the activation of specific EUDAMED modules, allowing them to become mandatory independently as they become operational. Previously, the entire EUDAMED system was slated to become compulsory only after all six modules were fully functional. Now, the Actor, UDI/Device, and Notified Bodies and Certificates modules are set to go live and enforce compliance in phases.
Key Modules and Deadlines
The Actor module, enabling registration and issuance of a Single Registration Number (SRN), is expected to be compulsory by Q1 2025, six months post-publication in the Official Journal of the European Union (OJEU).
Similarly, the UDI/Device module, which centralizes device registration, will eliminate the need for local databases starting six months after its OJEU release in 2025. The Notified Bodies and Certificates module requires immediate registration of new certificates and updates, with older certificates needing registration within 18 months of the module’s publication.
With the phased implementation of EUDAMED modules, stakeholders must promptly adapt to the new regulatory landscape to ensure uninterrupted market access. Emergo by UL advises immediate registration where possible and staying informed about upcoming mandatory publications in the OJEU.
Navigating the intricate timelines and requirements of EUDAMED necessitates proactive measures from all involved parties. By adhering to the newly established deadlines and leveraging available guidance, manufacturers and regulatory bodies can achieve seamless compliance. Staying ahead of these regulatory changes not only ensures legal adherence but also fosters trust and safety in the medical device market across Europe.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
