Since the EU is made up of 27 Member States plus Turkey, Liechtenstein, Iceland, and Norway who also follow EU rules concerning medical devices, these Member States may choose to demand an additional registration/notification prior to making medical devices or in-vitro diagnostic medical devices available on their market. This is usually a one-time requirement unless there is a significant change to the design and intended purpose of the device. Before this notification can be submitted your device must already be legitimately CE marked.
It is expected that once EUDAMED is fully functional, this additional registration/notification will become obsolete, however this is not guaranteed to be the case.
The following Member States are known to demand an additional registration/notification before placing a device on their market: Bulgaria, Greece, Croatia, Portugal, France, Slovakia, Italy, Latvia, Spain, Czechia, Estonia, Lithuania and Turkey.
Advena has full access credentials to many these national databases, and we can certainly help submit these notifications on your behalf.
For low-risk Class I devices an additional registration should not be required in any EU Member State, however we are aware that Italy and Turkey are making this demand.
Should you be interested in this service, please contact us and we can provide you with more information.
