Last week, the European Commission released a Q&A on practical aspects related to implementing the gradual roll-out of EUDAMED. In the following blog, we will cover highlights from the document and recommendations for the next steps.
What’s New with Regulation (EU) 2024/1860?
The amendment introduces three pivotal changes:
- Enhanced Patient Safety: Extends timelines for conformity assessments for certain IVDs under the IVDR, safeguarding healthcare continuity without compromising safety standards.
- Supply Interruption Notifications: Manufacturers must notify authorities and supply chains of anticipated device interruptions or discontinuations.
- Gradual Roll-Out of EUDAMED: Individual modules of EUDAMED (the European database on medical devices) can now be launched independently upon audit confirmation, expediting its functionality.
EUDAMED: Key Modules and Transition Timelines
EUDAMED comprises six modules designed to centralize device registration, compliance, and oversight. Below are the highlights of each module and their anticipated roll-out schedules:
- Actor Module (ACT)
- Purpose: Registers economic operators (manufacturers, importers, authorized representatives).
- Status: Voluntary registration since 2020; mandatory six months after audit confirmation.
- Action Item: All relevant operators should register immediately to meet future compliance deadlines.
- UDI/Device Module (UDI/DEV)
- Purpose: Tracks devices via UDI-DI (Unique Device Identifier-Device Identifier).
- Status: Available since October 2021 for voluntary use; mandatory six months after functionality confirmation.
- Requirement: Devices placed on the market before mandatory use must be registered within 12 months of the functionality notice.
- Notified Bodies and Certificates Module (NB/CRF)
- Purpose: Registers certificates issued by notified bodies.
- Status: Voluntary use since 2021; mandatory six months post-confirmation.
- Action Item: Notified bodies should proactively register certificates to align with future requirements.
- Post-Market Surveillance and Vigilance Module (VGL)
- Purpose: Facilitates reporting of safety issues, incidents, and surveillance outcomes.
- Status: Not available for voluntary use; mandatory six months post-confirmation.
- Implication: Manufacturers must shift ongoing surveillance reports to EUDAMED once the module is active.
- Market Surveillance Module (MSU)
- Purpose: Exclusively for competent authorities to monitor device compliance.
- Status: Restricted access; mandatory six months after functionality confirmation.
- Clinical Investigations/Performance Studies Module (CI/PS)
- Purpose: Manages clinical trials and performance studies.
- Status: Not available voluntarily; mandatory six months post-confirmation.
- Timeline: Coordinated assessments become mandatory five years post-confirmation for all EU member states.
Practical Guidance for Stakeholders
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Early Registration: Proactively register in available EUDAMED modules, such as the Actor and UDI/Device modules, to streamline transitions to mandatory use.
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Data Preparedness: Ensure readiness by cleansing and structuring datasets to align with EUDAMED requirements.
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Monitor Deadlines: Stay informed of audit confirmations and corresponding transition timelines published in the Official Journal of the European Union (OJEU).
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Engage Stakeholders: Collaborate with notified bodies, competent authorities, and internal teams to coordinate compliance efforts effectively.
Conclusion
The phased roll-out of EUDAMED reflects the EU’s commitment to improving medical device oversight while providing stakeholders with a structured transition path. Manufacturers, importers, and regulators must prioritize proactive engagement with the system to ensure seamless compliance and continued market access.
Stay tuned for updates on EUDAMED implementation and further guidance on leveraging its modules for regulatory success. Contact us to schedule a free consultation. We are here to help.