March 2 is approaching, bringing with it the obligation for distributors, service providers, and manufacturers of custom-made devices to review and confirm their data in the ISZP system. This step should not be underestimated—failure to confirm the data on time could lead to the loss of a registered person status. And that’s not a problem that can be resolved in just a few days. Even obtaining access to ISZP, setting up permissions, and logging in for the first time is not a matter of a few clicks but can take days or even weeks.
Manufacturers, authorized representatives, and importers of medical devices should also pay attention and check their registrations in the Czech RZPRO system, ideally starting their registration in the European Eudamed database. In RZPRO, we recommend a thorough review of all entered data to ensure compliance with legislation and reflect the actual status. As for Eudamed, now is the ideal time to complete voluntary registration. Registration is currently free, which will not be the case in the future. The data confirmation process is relatively lenient at the moment, making approval less complicated. Moreover, having a completed Eudamed registration can serve as a competitive advantage. Lastly, it is a matter of time efficiency—currently, processing is fast because the system is not overloaded, but as the mandatory registration deadline approaches and requests increase, this will undoubtedly change.
It is important to note that Eudamed is being introduced gradually, and not all of its modules are available for voluntary use. So far, the modules for registering economic operators, UDI and medical device registration, and notified bodies and certificates are accessible. However, the vigilance and post-market surveillance, clinical investigation, and market surveillance modules are not yet available for voluntary use and will only be launched once their mandatory use begins.
For manufacturers, authorized representatives, and importers, one rule applies: the sooner you start, the better. For distributors, service providers, and manufacturers of custom-made devices, the situation is more urgent—if you miss the March 2, 2025, deadline, you will lose your mandatory ISZP registration, and reinstating it will cost you time and money. Continuing business activities without this registration also puts you at risk of a significant fine. If you need any advice or encounter issues with ISZP, RZPRO, or Eudamed, we are here to help you save time, costs, and unnecessary complications.
Author: Aneta Dostálová