In Europe, EUDAMED is already serving as the database on Medical Devices under the old directives. The second version will be more comprehensive, detailed, protected, web application that will functions under the new EU MDR and EU IVDR. The second version will be enhanced to ensure transparency and error proofing and will again work as a reference point between the European Commission (EC) and the local competent authorities. As the regulations had already been released, the EC is making the new Medical Devices EUDAMED ready for use. Although due to CoVID-19 the transition period has bit delayed for the EU MDR. For companies; offering in vitro diagnostic devices (IVDs); the transition period is bit flexible with additional couple of years. Economic operators are therefore concerned about the new requirements of the database; this piece will help them in comprehension of EUDAMED.
What is Single Registration Number (SRN)?
The SRN is a distinctive code used for categorical identification of an economic operator within the EU. A company needs one SRN as per the economic role.
Case 1: So for example; an organization manufactures a medical device; they will need one SRN for manufacturing. And if the same organization also imports a device from non-EU state; they then require an additional SRN for the second role as “importer”. Thirdly if the organization is also an authorized representative for the imported medical device, then the company required a third SRN for this additional role as an authorized representative. This is shown in Case 1.
Case 2: The second case identifies a medical device manufacturer but having multiple sites. So as the role is singular they will only need a single SRN as shown in Case 2.
Case 3: In the third case; if a company serves as authorized representative for multiple non-EU manufacturers, only one SRN will be needed for this role. Hence each SRN is concerned to a specific role, and so each SRN will have some responsibilities related to the access and change in data entry and its records.
What is Local User Administrator (LUA)?
When sending application for an SRN, the LUA must also be chosen. The LUA can endorse local operators (users) within an SRN, which stresses the significance of this privilege within the EUDAMED system. There is no constraint to the number of users; the LUA can chose, and operators may have explicit access control depending on the requirements. For continuity of operations, more than one LUA can be appointed. The identity of LUA has to be confirmed by official authorities.
Who will issue SRN and LUA?
National Competent Authority will disburse the registration for SRN and LUA. For companies in EU; it is the Competent Authority (CAs) of the Member State where they are situated. For manufacturers in a non-EU country, this will be the Member State where their Authorized Representative (AR) is present. For sponsors in the non-EU country, this will be the Member State where their Legal Representative (LR) is present. It is advised to communicate your LA or AR, examining about the standing of SRN application.
Role of Importers, AR, Manufacturers, Distributors
A manufacturer enjoys the privilege to offer medical devices directly to end consumers. But majority of the manufacturers will engage distributors for this objective. Distributors are not anticipated to feed the data in EUDAMED, but they should have the privilege to access data to verify that their device information is accurate.
Manufacturers present outside the EU must manage their devices through an importer on the market. The role of the importer is meaningfully changed with the distributor. The importer must register the company profile in EUDAMED and send application for a Single Registration Number (SRN) and employs a Local User Administrator (LUA).
For an importing organization, it is also possible that they are the authorized Representatives for the non-EU manufacturer. In such situation, the company has to acquire two SRNs; one for the importer role and one for AR role. The AR and/or importer may empower the non-EU manufacturer in reaching the EUDAMED and feeding data, but they cannot utilize their status as of the manufacturers. The AR or importer has to employ the manufacturer’s SRN to submit the relevant data of that manufacturer. The LUA of the manufacturer may appoint operators or users from the AR or importer. It is also likely for a device maker to have others feeding their data by permitting them to use their SRN.
Performance Studies and Clinical Studies
Clinical studies are done to study the performance and safety of the usual medical devices under EU MDR, whereas performance studies examine the performance of in-vitro diagnostic devices (IVDs). On the other hand, now the clinical performance studies; which are contemporary or will be performed in future in Europe needed to be submitted into EUDAMED. The sponsor is legally responsible for feeding data, but it can provide other entities (for instance legal representative, contract research organization etc.) the access to its SRN for entering data. Comprehensive data entry is vital; no reference to other databases is allowed.
Analysis performed on CE devices, under the grounds of Post-Market Performance Follow-up (PMPF) and Post Market Clinical Follow-up (PMCF) studies, within the space of their planned implementation, will also require submitting information to EUDAMED. Other PMPF or PMCF examination does not need data to be submitted in EUDAMED.
Test environment for EUDAMED
The test environment is in-planning phase and it will be accessible soon in the recent year 2019. Once accessible the environment will be available to relevant entities. The EUDAMED test environment will be utilized for training drives.
Alysidia is the Ultimate Solution for EUDAMED
Alysidia is the ultimate solution for EUDAMED; it’s a one roof solution for EU UDI and EUDAMED. Alysidia recommend companies to kick-start planning about the implementation for the EUDAMED. As the time has come to go live soon, it is recommended not to delay. Send your queries today to Alysidia support portal and let us help you in planning, preparation of EUDAMED and UDI.