EUDAMED for actors’ role is becoming enforced by December 2020. All medical devices’ authorized representatives, importers, manufacturers, and other important actors in the European market must get themselves incorporated along with their roles in the system. The information is required to be provided in the first module titled as the EUDAMED Action Registration module. Action Registration module is one of the six modules. EUDAMED system will consequently create an SRN (Single Registration Number) and will report the actor via email.
What is the Significance of Single Registration Number (SRN)?
The SRN must be attained in advance of the CE marketing procedure planned to be submitted to the notified body for a specific medical device. In case when the involvement of the body is not expected, it must be completed before marketing the medical device in Europe.
Also, the manufacturer in case of conformity assessment is required to submit this unique registration number to the notified body. Moreover it will also be required to use the electronic EUDAMED system.
Structure of Single Registration Number (SRN)
The structure of SRN is illustrated as under;
As illustrated, SRN is structured in three different segments; the second segment is related to the Role. Some roles along with their abbreviations are furnished below:
- MF for Manufacturer
- AR for Authorized Representative
- PR for Kit and system manufacturer
- IM for Importer
Documents to be furnished for SRN Registration
For the intent of acquiring the SRN on the Actor registration module, the following data is necessary to be furnished:
- Economic operator type (producer of kits, manufacturer, authorized representative, and / or importer)
- Name, Contact details, address of the economic operator
- Name, Contact details, address of the individual sending information in situation if information is provided by second party for one of the economic operators.
- Name, Contact details, address of the persons looking after compliance against MDR
- Responsibility Statement for Information Security
- Agent summary document
It is important to note that the above data is obtainable for public usage also.
Verification of Data & Routing Changes
The economic operator confirms the correctness of the information within one year of data submission and every second year beyond the first verification .In the event of a change to the registered information, the economic operator, is liable to update the information within a week, so that the system reflects the change.
Alysidia SRN Registration Support
Alysidia is offering registration support services from 1 December 2020 to all companies operating in the European market or looking forward to market their devices in Europe. Alysidia will be on disposal to start the standard registration process of economic operators within the EUDAMED; Actor Registration Module. Contact Alysidia support quickly beforehand to manage compliance in-advance.
