Updates on the Gradual Rollout of EUDAMED - 2025 and Beyond
The gradual rollout of EUDAMED is a significant component of the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). EUDAMED is designed as a comprehensive database that centralizes critical information related to the safety, performance, and market surveillance of medical devices sold in the EU. Initially, the system was expected to become fully operational by 2022, but technical challenges have delayed its full implementation. The European Commission has responded to these delays by adopting a phased rollout, which allows certain functionalities of the database to become operational as they are completed, without waiting for the entire system to be finished.
At its core, EUDAMED comprises seven interconnected modules: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance, Market Surveillance, and Post-Market Surveillance. As of 2024, four of these modules are functional, and two more are expected to be completed by the end of the year. The Clinical Investigations and Performance Studies module has faced delays due to technical complexities, making it the only component that will not be ready in 2024. Despite this, the gradual deployment means that stakeholders can begin using the available modules, reducing the wait time for the system’s benefits.
The European Commission decided to implement the available EUDAMED modules in stages because of the need to balance regulatory enforcement with the technical realities of building such a large-scale database. With each new module that becomes functional, the regulatory requirements tied to that module become enforceable, allowing manufacturers, regulators, and economic operators to integrate these new tools into their compliance workflows. This phased approach reduces the burden on manufacturers by giving them access to the database’s functionalities as they become available, rather than delaying everything until all modules are complete. This approach is especially beneficial for ensuring smooth transitions and helping stakeholders adjust progressively to the new regulatory environment.
One significant element of EUDAMED is its role in providing transparency and ensuring better traceability of medical devices across the EU market. Each module is intended to enhance the oversight of specific aspects of medical devices. For example, the UDI/Device Registration module enables the traceability of medical devices through the Unique Device Identifier (UDI) system, which is crucial for tracking devices through their lifecycle, from production to patient use. The Vigilance module will allow the central collection of incident reports, helping regulators and manufacturers respond more quickly to safety issues. This data centralization is a key objective of the MDR and IVDR, as it supports a stronger post-market surveillance framework, increasing patient safety across the EU.
A new provision included in the rollout is the requirement for manufacturers to report interruptions or discontinuations of the supply of critical medical devices under Article 10a of the MDR and IVDR, which will take effect on 10 January 2025. This requirement is designed to ensure continuity of care, particularly for devices that are critical to patient health. Manufacturers must notify authorities at least six months in advance of any anticipated disruptions to their supply chains. This information will be logged into EUDAMED, providing visibility to regulators and healthcare providers, allowing them to prepare for any potential shortfalls and mitigate risks to patient care. This proactive reporting mechanism highlights the EU’s focus on safeguarding public health while ensuring that the supply of essential medical devices is closely monitored.
The gradual rollout of EUDAMED demonstrates the EU's commitment to enhancing medical device regulation while managing the technical and logistical challenges of implementing such a vast system. The phased approach allows regulators and manufacturers to adapt to the evolving requirements of the MDR and IVDR without overwhelming stakeholders. While full functionality is still pending, the modules that are currently operational provide a solid foundation for improved device traceability, market surveillance, and overall patient safety. This gradual but steady progress ensures that the system’s benefits are being realized while maintaining flexibility to accommodate the complexities of building such a robust regulatory tool.
The rollout is described in the chart provided in the link below:
For IVDR:
The document (MDCG 2022-12) provides alternative solutions for various provisions of the In Vitro Diagnostic Regulation (IVDR) until the Eudamed system is fully functional. Here is a summary of the alternative solutions by article:
Article 26: Registration of devices – While Eudamed is partially functional and can be used voluntarily, manufacturers should follow national product registration schemes. The assignment of UDI (Unique Device Identifier) is mandatory from 26 May 2022.
Article 28: Registration of manufacturers, authorized representatives, and importers – Voluntary use of Eudamed for actor registration is possible, but national registration schemes should be referred to until Eudamed is fully functional.
Article 29: Summary of safety and performance (SSP) – Until Eudamed is fully operational, the SSP should be made available to the public on request or specified where it can be accessed.
Article 30: European database on medical devices – Voluntary submission to Eudamed is possible for the modules available, but submission is not mandatory until full functionality is announced.
Article 36: Nomination of experts for joint assessment – The Commission provides secure directories in CircaBC for sharing information about experts with Member States.
Article 38: Designation and notification procedure – Notifications continue via NANDO, while additional documents are shared via CircaBC.
Article 39: List and identification numbers of notified bodies – The list is published on NANDO and will be transferred to Eudamed when available.
Article 49: Conformity assessments – Notified bodies should upload information on withdrawn applications to a secure CircaBC directory.
Article 50: Certificates for class D devices – Certificates should be uploaded to CircaBC and will be shared in Eudamed once fully functional.
Article 66: Application for performance studies – Applications should be submitted via national procedures, with a list of national contact points available on the Commission’s website.
Article 73: Information at the end of a performance study – Reports are submitted through national procedures. Once Eudamed is functional, these will be uploaded to it.
Article 76: Adverse event reporting – Reporting is done through national systems until Eudamed's module is ready.
Article 81: Periodic safety update reports (PSUR) – PSURs should be delivered to notified bodies via secure email and uploaded to national systems where necessary.
Article 88: Market surveillance – National authorities should upload surveillance reports to CircaBC.
Article 90: Devices presenting unacceptable risk – Authorities notify the Commission and other states through encrypted communication (email or other).
Article 93: Preventive health protection measures – Member States use encrypted email for notifications about preventive measures.
These alternative solutions enable continued compliance with IVDR while minimizing the burden on manufacturers and authorities until Eudamed is fully functional.
For EU MDR
The document (MDCG 2021-1 Rev.1) outlines alternative solutions for certain provisions under the Medical Devices Regulation (MDR) until EUDAMED becomes fully functional. Here’s a summary of the alternative solutions by article:
Article 29: Registration of devices – Manufacturers should use national product registration schemes for device registration until EUDAMED is fully functional. The UDI assignment requirements remain mandatory.
Article 31: Registration of manufacturers, authorized representatives, and importers – Registration can be completed through national systems, and manufacturers must follow national procedures until the EUDAMED module is available.
Article 32: Summary of safety and clinical performance (SSCP) – SSCPs should be made available to the public or specified where they can be accessed.
Article 33: European database on medical devices – EUDAMED modules can be used voluntarily once available, but full functionality is required before it becomes mandatory.
Article 40: Nomination of experts for joint assessments – Information about nominated experts is shared via the CircaBC directory until EUDAMED is operational.
Article 42: Designation and notification procedure for notified bodies – Notifications will continue via NANDO, with additional documents shared via CircaBC.
Article 43: List and identification numbers of notified bodies – Information is published on NANDO and will transition to EUDAMED when ready.
Article 56: Certificates of conformity – Certificates should be made available upon request or uploaded to national systems, transitioning to EUDAMED once it is operational.
Article 70: Applications for clinical investigations – Applications should be submitted via national systems. A list of national contact points will be provided by the Commission.
Article 86: Periodic safety update reports (PSUR) – PSURs should be submitted through national systems and to notified bodies, pending the availability of the EUDAMED module.
Article 87: Reporting of serious incidents and field safety corrective actions – Serious incidents should be reported via national vigilance systems using updated forms adapted to MDR requirements.
Article 88: Trend reporting – Trend reports should be submitted via national vigilance systems using the current form until EUDAMED becomes available.
Article 93: Market surveillance activities – Surveillance summaries are to be shared via CircaBC.
Article 95: Devices presenting an unacceptable risk – Information should be shared through secure email or other encrypted communication channels until EUDAMED is functional.
These solutions allow stakeholders to comply with MDR provisions in the absence of a fully operational EUDAMED.
