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:
- to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators;
- to enable unique identification of devices within the internal market and to facilitate their traceability;
- to enable the public to be adequately informed about clinical investigations or performance studies and to enable sponsors of clinical investigations or of performance studies to comply with obligations under MDR or IVDR.
- to enable manufacturers to comply with the information obligations under MDR or IVDR
- to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.
Who are the actors?
Under MDR and IVDR the following entities shall be registered in EUDAMED:
- Manufacturer (or legal manufacturer)
- Authorized Representative (AR)
- System and procedure pack producer
- Importer
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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