Everyone has an insight into the compliant registration in EUDAMED.
For a few days now, we have been watching with excitement as the EUDAMED database gradually fills up.
The first glance is at our own company. "A hit! We're in!" - This or something similar is happening in many places. The second glance may be in the direction of competitors.
Is my competitor registered?
Unlike in the past, everyone now has access to the compliant registration in EUDAMEDThis will map the life cycle of medical devices offered in the EU in real time. Various electronic systems will be integrated into the EUDAMED database so that information about medical devices and the respective companies can be collected and processed. This will significantly increase transparency through access to information for all.
In addition to the registration of economic operators, i.e. manufacturers (EU and non-EU), importers and European Authorised Representatives (EU-REP), there will also be
- UDI (Unique Device Identification) and product registration,
- Notified bodies and certificates,
- clinical trials and performance studies as well as
- vigilance and market surveillance will also be visible in the database.
What do I need to register?
To register in EUDAMED, a declaration on information security and a summarised mandate declaration or non-EU actors are required.
is required. In addition to the member states, Iceland, Liechtenstein and Norway have access to EUDAMED. The UK, Switzerland and Turkey are not included. Persons subject to registration from these countries will only be able to register with an Authorised Representative (EU-REP) registrieren können.
Further information and FAQ can be found on the EU Commission website or by talking to our advisors.
