Regulation 2024/1860 - News on EUDAMED
The European database for medical devices, EUDAMED, is a central IT system that was introduced by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It is intended to improve the transparency and traceability of medical devices in the EU and facilitate the work of manufacturers, notified bodies and authorities.
Regulation 2024/1860 sets new timelines for EUDAMED and changes the transition periods
The modules
EUDAMED consists of six interconnected modules and a public website. The database serves as a central source of information for authorities, notified bodies and economic operators. Among other things, it supports the registration of actors and products, the monitoring of market activities and the documentation of clinical trials and vigilance notifications.
The six modules of EUDAMED are:
- Actor Registration
- UDI/device registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance
Current status of implementation
Although EUDAMED is intended as a central component of MDR and IVDR implementation, its use is not yet mandatory. Some modules are already available and can be used voluntarily:
- Actor registration: Available since December 2020
- UDI/product registration: Available since October 2021
- Notified bodies and certificates: Available since October 2021 (but without verification mechanism and clinical evaluation procedures)
The remaining modules (vigilance, clinical trials and market surveillance) are still under development. They will only become mandatory after a successful review and an official notification in the Official Journal of the EU.
When will EUDAMED become mandatory?
In accordance with the amended transitional provisions of Regulation (EU) 2024/1860, a phased introduction of Eudamed was decided. The mandatory use of the already functional modules of the system began on January 10, 2025. The aim of this measure is to give manufacturers more time to adapt to the new requirements and to ensure that the system is fully operational and reliable.
The use of the individual modules becomes mandatory six months after their official release. Release takes place after an independent review, notification of the Medical Devices Coordination Group and finally publication by the European Commission.
Relevant article: Article 34 MDR
- Individual EUDAMED modules become mandatory as soon as they are functional and not only when all modules are functional.
- A module becomes mandatory six months after official confirmation of its operability by the European Commission, i.e. publication in the Official Journal.
- This applies to the modules on actor registration, UDI/device registration, notified bodies and certificates, vigilance, market surveillance and clinical trials.
- Effects: Manufacturers must prepare for a staggered changeover and start using them at an early stage in order to facilitate subsequent mandatory use.
According to the current EUDAMED Timeline , the publication of the Actor, UDI/Devices, NBs & Certificates and Market surveillance modules in the Official Journal is planned by Q3 2025. The Vigilance module should follow by Q2 2026.
Accordingly, the use of the first modules mentioned would be mandatory from Q1 2026 and the use of the vigilance module is estimated to be mandatory from Q1 2027.
Manufacturers should check EUDAMED timelines regularly for updates!
There is a „Gradual Roll-out of EUDAMED“ on the website of the European Commission and the MDCG, with helpful Q&A and a flowchart.
Caution! It only makes sense to use the flowchart as soon as:
- the functionality of the UDI/DEV module and vigilance module has been officially confirmed
- all transitional periods for registration in the UDI/DEV module have expired
- and the use of the vigilance module becomes mandatory.
When do MDs and IVDs have to be reported in the UDI/DEV module?
The following points can be regarded as a basic rule for the registration obligation:
- Products that continue to be placed on the market after 01.01.2026 must be registered by 01.07.2026.
- Products that are only placed on the market for the first time on or after 01.01.2026 must be registered before being placed on the market.
- Products that are no longer placed on the market before 01.01.2026 do not require registration.
When do MDs and IVDs have to be reported in the UDI/DEV module?
"Legacy Devices"
- Legacy devices are devices that were originally approved under the old MDD or IVDD and still have a transition period for the MDR/IVDR
- If a product is placed on the market under the old directive by 31.12.2025 at the latest, no registration is required
- If the product is resold after 01.01.2026, it must be registered by 01.07.2026 at the latest
- If the product is converted to the MDR/IVDR before 01.01.2026, separate registration is no longer necessary
Testing necessary:
If the device has been converted from a legacy device to an MDR/IVDR device, it must be checked whether it is the same device ("same device" e.g. same UDI, trade name, REF number, see also "Gradual roll-out of EUDAMED"). If it remains the same device, registration can be omitted.
Exception: Immediate registration requirement for PMS or vigilance measures
If a product is included in a post-market surveillance (PMS) or vigilance action (PMSV action), it must be registered immediately, regardless of the date of placing on the market.
Examples of PMS/vigilance measures:
- Field Safety Corrective Actions (FSCA)
- Reports of serious incidents
- New clinical findings that influence risk assessment
New transition periods for IVDs
The deadlines for IVDs have been further extended in order to avoid bottlenecks at Notified Bodies.
- Class D: until December 31, 2027
- Class C: until December 31, 2028
- Class B and sterile class A: until December 31, 2029
Please note: To extend the deadline, however, manufacturers must have sent a formal application and then implemented a written agreement with their notified body.
Supplementary details referred to in Article 110 (3c) (e) and (f):
- The application for conformity assessment in accordance with Annex VII, section 4.3, subparagraph 1 must be submitted no later than:
- Class D until May 26, 2025
- Class C until May 26, 2026
- Class B and sterile class A until May 26, 2027
- The written agreement with the notified body referred to in the second subparagraph of Section 4.3 of Annex VII must be concluded no later than:
- Class D until September 26, 2025
- Class C until September 26, 2026
- Class B and sterile class A until September 26, 2027
Reminder
Regulation (EU) 2023/607 has already specified the transition periods for legacy devices:
- The previous transition periods remain in place for medical devices under the MDD. This means that legacy devices must be converted to MDR by 2027 or 2028 at the latest (depending on the risk class). (MDR, Article 120, (3))
- Class III, implantable class IIb and certain IIa devices: until December 31, 2027
- Other class IIb and IIa products: until December 31, 2028
- Class I (if previously certified by a Notified Body): until December 31, 2028
Effects for manufacturers
- Manufacturers must prepare for UDI registration at an early stage, especially for devices that could be affected by a vigilance measure in the next few years or that will be placed on the market under MDR/IVDR after 01.01.2026.
- Companies should keep an eye on the deadlines for the conformity assessment and ensure that MDR/IVDR-compliant certificates are available in good time.
- If a legacy device is no longer actively marketed, registration in EUDAMED is not required - unless a safety measure becomes necessary.
What else will Regulation 2024/1860 bring?
Duty to inform in the event of interruption or cessation of supply
Relevant article: New Article 10a MDR/IVDR
- Manufacturers must inform authorities and affected economic operators at least six months in advance if they interrupt or discontinue the supply of a product.
- This is especially true if the product is important for healthcare and a supply shortage could have a serious impact on patients.
- If an interruption occurs unexpectedly and at short notice, manufacturers must provide information immediately. Implications: Regulatory and supply chain teams in companies will need to introduce new processes to submit such notifications in a timely manner.
Conclusion
Manufacturers and other economic operators should familiarize themselves with the requirements of EUDAMED at an early stage. Registration as an actor and UDI product registration are particularly important, as these modules are already available and voluntary use facilitates subsequent conversion.
Current developments and new deadlines are regularly published by the European Commission. The latest information on EUDAMED implementation can be found on the official website of the European Commission.
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