Author: Suzanne Broussard
One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and in vitro device regulations (IVDR) and is by all accounts an ambitious project.
The version of Eudamed currently in use (Eudamed2) is a secure web-based portal designed to conduct effective market surveillance on medical devices through information exchange between competent Authorities and the Commission.
Eudamed 3 will be dramatically different when it eventually rolls out. Eudamed 3 is designed to be multipurpose and function as a:
- Registration system
- Collaborative system
- Notification system
- Dissemination system (open to the public)
The original intention was that the newest Eudamed database would launch at the same time as the original MDR date of application. However, challenges in preparing the new updated system forced the delay by 2 years. Under this delay, Eudamed 3 will roll out on 26 May 2022.
Now, the European Commission has announced that the different modules will gradually be made available as they are functional. Here is the estimated rolled out of the modules.
- The module on actor registration will be the first deployed (latest deployment date of March 2021).
- The unique device identification (UDI) module will be available no later than May 2021.
- The device registration module will be available no later than May 2021.
- The notified bodies certificates will also be available no later than May 2021.
- The remaining vigilance, market surveillance, and clinical investigations modules will be active once they are functional or 26 May 2022 at the latest.
The earlier release of the actor registration takes significant pressure off economic operators and competent authorities since all “actors’ are required to register on Eudamed 3 to obtain the required single registration number (SRN) created by Eudamed after the device validation by a competent authority. Obtaining the SRN much earlier than 2022 allows the economic operative the ability to proceed with labeling and design processes. The SRN is critical for compliance with product registration, submission of clinical trial dossiers, and post-market surveillance, as well as vigilance and market surveillance under MDR.
The large number of “Actors” required to register includes the manufacturer, authorized representative, importer, notified body, competent authority, Commission, and public. Getting all these actors registered was seen as a big bottleneck in the system, and the early release significantly dampens the time crunch faced by competent authorities.
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What is the state of play of the implementation of EUDAMED?
- The development and implementation of EUDAMED is a high priority for the Commission.
- We have pledged, in agreement with the MDCG, to gradually make the different modules available as soon as they are functional.
- We will make the module on actor registration available first, deploying it by March 2021 at the latest.
- We will make the module on UDI/device registration (second module) and the module on certificates and notified bodies (third module) available by May 2021. The remaining modules will become available afterwards as soon as they are functional.
We update the documents below under ‘functional specifications’, ‘MDR/IVDR UDI and device’, and ‘data exchange’ as new information becomes available. Please check back regularly for the latest versions as they are subject to adjustments and fine-tuning. Ref European Commission at this link.