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EUDAMED is an online system that aims to centralize and harmonize the data related to medical devices across the European Union. It is a vast repository containing information on medical devices, manufacturers, clinical investigations, market surveillance, and other critical data. The overarching goal of EUDAMED is to strengthen regulatory oversight and patient safety within the EU.
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project. The following are the most recent updates to the EUDAMED timeline:
The European Commission is evaluating the development roadmap for EUDAMED. EUDAMED development roadmap (EC, Oct 2023) became public on October 20, 2023. Development and module interdependencies are affecting the timing, according to MedTech Europe.
The development of the CIPS module is taking longer than expected due to its complexity and change requests. As a result, DG SANTE has redirected resources from the ‘Use Case’ development. Therefore, the European Commission has decided to pause the development of the CIPS module until all other modules are completed.
Once the audit starts on the first five modules, they will resume working on the CIPS module development, which is expected to take over two years to complete. It is important to note that EUDAMED can only be enforced as a mandatory system once it is finished with all modules.
MedTech Europe will examine these developments in more detail and communicate their potential impact on manufacturers. The industry must closely monitor the effect of delayed transparency, continuous compliance with national databases, and legacy device registration.
Industry insiders recommend continued diligence and voluntary data submission.
Manufacturers should continue data cleansing, assigning Basic UDI-DI, and preparing for risks.
* The timeline has not yet been officially finalized. We will continue to monitor any changes as they develop.
As of 2024-Jan-23, the EU Commission proposes to extend transition periods for certain IVDs, gradual roll-out of EUDAMED and an information obligation in case of interruptions to supplies.
See the latest postings by the EU Commission:
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