EUDAMED (European Database on Medical Devices) is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro medical devices, created to improve transparency and coordination of information regarding medical devices available on the EU market.
It is composed by six modules and a public website (“ec.europa.eu/tools/eudamed”). The six modules are: actors’ registration, Unique Device Identification (UDI) and devices registration, notified bodies and certificate, clinical investigations and performance studies, vigilance and post-market surveillance, market surveillance.
The purposes of EUDAMED, according to MDR Article 33 and IVDR Article 30, are:
Who are the actors?
Under MDR and IVDR the following entities shall be registered in EUDAMED:
Registration of the actors is mandatory, not complying to this requirement can probably lead to the rejection or denial of a market authorization.
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