he 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 needed to be presented in the first module named 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 acquired prior to the submission to the notified body to commence the CE marking process for a device, or in the situation that the involvement of the body is not anticipated, it must be done before placing the medical device on the market.
The manufacturer needs to submit this unique registration number for conformity assessment to the notified body; moreover it will also be needed to access the EUDAMED.
Composition of Single Registration Number (SRN)
The composition of SRN is illustrated as under;
As illustrated, SRN is composes in the three units, the second one is the Role abbreviation. Some roles and their abbreviations are listed 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 needed to be submitted:
- 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.
Wants to Read More About: GUDID
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
TS Q & E is offering registration support for all our clients, companies and any prospective economic operators in the market. 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.
About GUDID FDA USA
The FDA’s Global Unique Device Identification Database (GUDID) is a searchable database that allows anyone to obtain information on medical devices. The medical devices labellers are initially submitting data regarding identification of device, i.e. UDI (Unique Device Identification).
What Information Needs To Be Sent To The GUDID
The GUDID is a system for labelers and Issuing Agencies to identify and submit device information. A GUDID comprises around 50+ data attributes. The system automatically fills in some fields. For example, the Labeler Name and Address field is automatically pulled from the DUNS database, and various Issuing Agencies provide the Device Identifier field. However, some fields, like Device Identifier, must be filled in manually. Fortunately, built-in business rules and a controlled vocabulary help ensure that the data submitted is valid.