Client communication: EUDAMED gradual roll-out
[Contenuto in lingua inglese]
Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR) require manufacturers and Notified Bodies to submit certain information and documentation to the EU database EUDAMED (European Database on Medical Devices).
What is EUDAMED?
EUDAMED is a multi-purpose IT system being developed by the EU Commission that will collate, process and disseminate information about medical devices/IVDs and related economic operators (such as manufacturers) to various stakeholders. EUDAMED aims to enhance overall transparency, including better access to information for the public and healthcare professionals, and enhance coordination between the different Member States in the EU. The system will comprise six modules related to:
- Actor registration
- Unique device identification (UDI) and device registration
- Notified Bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market surveillance
Some of these modules are already live and available for voluntary use. According to the original requirements of MDR, IVDR, use of EUDAMED is mandatory only after all the modules have achieved full functionality.
There is EU guidance on practices in the transition to full availability of EUDAMED for MDR and IVDR (MDCG 2021-1, MDCG 2022-12).
According to the previous roadmap published by European Commission (EC), the use of EUDAMED was anticipated to become mandatory in 2029.
Amending Regulation (EU) 2024/1860 and EUDAMED gradual roll-out
On 9th July 2024, the amending Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) with immediate effect.
The objective of the amending Regulation is to further mitigate the risk of shortages of medical devices on the market by:
- Extending the transitional periods for certain in vitro diagnostic medical devices (IVDs) if certain conditions are met.
- Obliging manufacturers to inform the relevant national competent authorities in case of their intention to interrupt/withdraw the supply of certain critical medical devices and IVDs.
- Implementing a gradual roll-out of the EUDAMED database, through making mandatory, the use of those EUDAMED modules that are already available for voluntary use once they are declared to be functional; instead of waiting for all the modules to become available and be declared functional before their mandated use.
As referred to above, the first three of the six EUDAMED modules are already available for voluntary use (Actor registration; UDI and device registration; Notified Bodies and certificates). As per the recent updates from European Commission, two other modules (vigilance and post-market surveillance; market surveillance) are expected to be completed in 2024 and these five modules are anticipated to be declared functional around mid 2025. The module covering clinical investigation / performance studies is not expected to be completed before Q3 2026. Details are in the updated roadmap published by the EC.
The amending Regulation (EU) 2024/1860 makes the use of the available EUDAMED modules mandatory as per the below timelines, that apply after a notice is published in the Official Journal of the European Union (OJEU) that the relevant modules are functional and meet the specifications.
Timelines relevant to manufacturers for modules anticipated to be declared functional in 2025 are shown below:
Publication of the notice of module functionality in OJEU
No later than 6 months after publication of the notice:
Actor registration: Economic operators must register themselves
UDI / Device registration: Manufacturers must register their Regulation devices in EUDAMED before placing them on the market*
Vigilance and post-market surveillance module: Manufacturers must report serious incidents and field safety corrective actions, and submit trend reports.
Manufacturers must submit PSURs for class III devices or implantable devices
Clinical investigations and performance studies module
No later than 12 months after publication of the notice:
UDI / Device registration: Manufacturers must complete registration of Regulation devices and legacy devices (unless the equivalent Regulation device is already registered) that were placed on the market before the mandatory use of the UDI/Device module and that continue to be placed on the market also after that date
*Note: for the purpose of the device registration in the UDI module, the term ‘placing on the market’ refers to the instance when the first product of a given device (e.g. identified with the same UDI-DI) is placed on the market.
Timelines relevant to Notified Bodies in relation to Notified Bodies and Certificates module:
No later than 6 months after publication of functionality of the module in the OJEU:
Notified Bodies shall start using EUDAMED to enter information regarding withdrawal and refusal of applications and regarding certificates (certificates issued, including amendments and supplements thereto, and suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates) on an on-going basis.
No later than 18 months after publication of functionality of the module in the OJEU:
Notified Bodies shall complete submitting all relevant certification and associated information on MDR/IVDR devices that manufacturers registered in EUDAMED.
The summary of safety (and clinical) performance [SS(C)P] must be uploaded after the registration of the relevant certificate.
Where can I find further information on BSI interaction with EUDAMED?
You can visit our webpage for additional details and our dedicated brochure to know more about BSI plans to interface with EUDAMED.
We invite you to also review the dedicated EU Commision webpage on EUDAMED progress.
Yours sincerely,
Maddalena Pinsi
Associate Head of Medical Devices Notified Body & Senior Rgulatory Lead
Regulatory Services, BSI
