Last Friday it was published that EUDAMED will be delayed once again.
It is expected to be fully operational by 2027, as the implementation of the clinical investigation module will require until that time. All other modules will be finished by Q2 of 2024. This means that the 6- and 24-month timelines for the transitional period of EUDAMED obligations will start in 2027.
This delay does not mean that you can relax and postpone the registration of your organization as an economic operator or your device(s). Some Competent Authorities already require registration even though the regulatory requirement is not there yet. Also, some importers and Authorized Representatives expect that the company they are collaborating with has already taken these steps.
Ultimately, every manufacturer is obliged to register all MDR-certified devices they have sold. The earlier this is accomplished, the smaller the backlog will be, and the quicker the registration process will be completed.
Another factor to take into consideration is vigilance. If you have a vigilance case concerning one of your devices, it’s crucial to register it promptly. Registering your device in advance can help alleviate additional work during a potentially stressful situation.
If you need assistance in creating a UDI or setting up an EUDAMED system internally don't hesitate to
reach out. Keep your foot on the gas!