2021.05.11
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.
Eudamed is a great tool and should be implemented as quickly as possible. It does not only provide the storage place for pertinent product and other information but also has procedural aspects. For example we would expect if a vigilance report is being uploaded the relevant authority should be informed – AUTOMATICALLY. The communication between the Manufacturer, the EC REP, the Notified Body, the Competent Authority and the Commission will be facilitated via Eudamed.
The MDR indeed provides for provisions to work without Eudamed. The registration is good example. “Legacy products” should follow the MDR Eudamed registration requirement along with the full compliance MDR products. On the other hand if Eudamed is not in place, the MDR product should follow MDD registration process along with the legacy products. This all makes sense since it does provide one process for all.
The implementation of a voluntary Eudamed makes the issue not easier since the MDR requires the MDD registration as long Eudamed is not officially in place. Therefore, please be aware that the voluntary registration does not relieve the manufacturer from the current MDD registration, which is to follow the national transposition of the MDD registration requirements (see also the MDSS comments on the SRN number and other issues here).
All of this is not trivial and therefore the guidance is quite helpful and provides for all other Eudamed aspects in order to fulfill the MDR requirement.
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