December 02, 2020 Industry news
As part of the EU MDR, on 1 December 2020, the European Commission made available the Actor registration module for the EUDAMED.
It is the first of six EUDAMED modules to be made live.
If you work in the medical device industry, what do you need to do next?
Any medical device members supplying goods into the EU will need to register or have a representative register as an Actor in EUDAMED.
Why is this information needed?
This will enable medical device suppliers to continue supplying products into the EU. The designated person will be responsible for registering the unique product identification information for the devices being supplied to the necessary authority.
Once the Actor is registered, the Single Registration Number (SRN) will be assigned.
What is the SRN?
“The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain the SRN.
“The SRN guarantees an EU-wide unique identification for economic operators (also outside of EUDAMED).
“Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator”.
Another aspect that you need to know about is the Basic UDI-DI. Our next training session will run on 5 Jan at 10:30am GMT, so join us then to learn more. You can sign up for the session here.
Want to find out more?
Further information on the Actor module can be found on the EU’s Actor module FAQ page.