The EUDAMED’s 1st module is becoming compulsory from December 2020. All medical devices’ manufacturers, authorized representatives, importers, and other important actors in the European market must register themselves and their roles in the system. The data is need to be present in the first module name as the Action Registration module. It is one of the first of the six modules. EUDAMED system will accordingly generate a SRN and will notify the actor via email. SRN is an acronym of Single Registration Number.
Single Registration Number
The SRN must be acquire prior to the submission to the notify body to commence the CE marking process for a device. Or in the situation that the involvement of the body is not anticipate. It must do before placing the medical device on the market.
The manufacturer needs to submit this unique registration number for conformity assessment to the notify body. Moreover it will also be need to access the EUDAMED.
Composition of Single Registration Number (SRN)
The composition of SRN is illustrate as under;
As illustrated, SRN is composes in the three units, the second one is the Role abbreviation. Some roles and their abbreviations are list as under:
- Manufacturer (MF)
- Authorized Representative (AR)
- Kit and system manufacturer (PR)
- Importer (IM)
Data to be submitted for SRN Registration
For the objective of registering the SRN on the Actor registration module, the subsequent data is need to be submit:
- Economic operator type (manufacturer, producer of kits, authorized representative, and / or importer)
- Contact details along with Name, address of the economic operator
- Name, address and contact details of the person submitting information incase if information is released by other person on behalf of one of the economic operators referred to in the first point,
- Contact details along with Name and address and of the persons answerable for compliance with the legislation
- Statement related to the responsibility for Information Security
- Agent summary document
Please note that the above submitted data is available for public consumption as well.
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Review and Incorporating Changes
The economic operator verifies the accuracy of the information within one year of submitting the data and every second year afterwards .In the incident of a modification to the registered information, the economic operator, in a week span, incorporates the update in the electronic system.
TS Q & E Registration Support
The TS Q & E is offering registration support for all our clients, companies and any prospective economic operators in the market. And TS Q & E will be available to start the registration procedures of economic operators on the EUDAMED Actor registration module. Contact us quickly beforehand to manage your compliance.
How can we help manufactures with SRN number?
For example: If manufacturer ABC is situated in Austria and acting as manufacturer, then SRN will be issued only for the Manufacturer role. If manufacturer ABC is situated in Austria and acting as manufacturer as well as Importer, then two SRN will be issued one for Manufacturer role and second for importer role.