EUDAMED is the Database on Medical Devices in the Europe. It will be a protected web application which will serves as a reference point for the flow of information between the European Commission (EC) and the national competent authorities. The regulations have been prepared, the EC is making Medical Devices’ EUDAMED ready, and it is scheduled to go-live in March 2020. For organizations supplying medical devices (MDs); the transition period will end on 26 May 2020, which is the Date of Application – (DoA) of the MDR. For organizations supplying in-vitro diagnostic devices (IVDs); the date of application is 26th May 2022, and the transition period will also end on the same date. Medical devices’ suppliers and manufacturers are therefore worried about the new requirements of the database; the article will help them in simplifying the understanding of EUDAMED.
Guidance on EUDAMED
What is Single Registration Number (SRN) in EUDAMED System?
The SRN is a unique code utilized for explicit identification of an economic operator within the EU. A company requires one SRN as per her economic role. So for instance a company manufactures a medical device; the company needs one SRN for manufacturing. Also if the company imports a device from non-EU state; the company requires a separate SRN for the role of “import”. Thirdly if the company is also an authorized representative for the same imported medical device, then the company needs a third SRN for this role as an authorized representative as presented in illustration Case 1. But a medical manufacturer have multiple sites will require a single SRN as illustrated in Case 2. Also if a company serves as authorized representative for various multiple non EU manufacturers, only one SRN will be required for this role. Each SRN is related to a particular role, and so each SRN will have specific authorities concerning the access and modification of data entry and its records.
It is vital that each economic actor requests the SRN themselves. The authorized representative can only help the organizations to submit the applications themselves, but cannot do the job on their part as it is mandated by the regulations.
What is Local User Administrator (LUA)?
When submitting application for an SRN, the LUA must also be selected. The LUA can approve local operators (users) within an SRN, which emphasizes the importance of this position within the EUDAMED system. There is no restriction to the number of operators the LUA can select, and operators may have specific access control based on the needs. For business continuity, more than one LUA should be appointed. The identity of LUA has to be verified by approved authorities.
Who will issue SRN and LUA?
National Competent Authority will issue or appoint the SRN and LUA. For organizations in EU; it is the Competent Authority of the Member State where they are located. For manufacturers in a non-EU state, this will be the Member State where their AR is located. For sponsors in the non-EU state, this will be the Member State where their Legal Representative is located. It is recommended to approach your Local Authority or AR, inquiring about the status of SRN application.
Role of manufacturers, importers, distributors and AR
A manufacturer can supply medical devices directly to end users. However most of the manufacturers will employ distributors for this purpose. Distributors are not expected to enter data in EUDAMED, but they should have the access of data to confirm that their device information is correct.
Manufacturers located outside the EU must channelize their products through an importer. The role of the importer is however different with the distributor. The importer must register the company in EUDAMED and submit application for a Single Registration Number (SRN) and employs a Local User Administrator (LUA).
For an importing company, it is also possible that they are the authorized Representatives for the non-EU manufacturer. In such case, the company has to seek two different SRN; one for the role of import and one for AR. The AR and/or importer may help the non-EU manufacturer in accessing to EUDAMED and feeding data, but they cannot use their position as the manufacturer’s position. The AR or importer has to utilize the manufacturer’s SRN to feed its data. The LUA of the manufacturer may select users or operators from the AR or importer. It is possible for a manufacturer to have others feeding their data by allowing them to utilize its SRN.
Clinical Studies and Performance Studies
Clinical studies are utilized to study the performance and safety of medical devices, while performance studies analyze the performance of in-vitro diagnostic devices (IVDs). However, those clinical performance studies; which are current or about to launch in Europe need to be submitted into EUDAMED. The sponsor is liable for feeding data, but it can give others (such as contract research organization, legal representative etc.) the access to its SRN for entering data. Complete data entry is mandatory; no reference to other databases is permitted.
Analysis done for CE devices, under the pretext of Post Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF) studies, within the scope of their intended application, will also necessitate feeding information to EUDAMED. Other PMCF or PMPF studies do not require data in EUDAMED.
Test environment for EUDAMED
The test environment is in-preparation phase and it will be available soon within the year 2019. Once accessible the environment will be open to anybody. The test environment for EUDAMED will be used for training purposes.
TS Quality & Engineering can help you as AR
In this article, we have tried to simplify many issues, elements and compliance worries of medical devices companies about EUDAMED; however as many issues has yet to unveil, we recommend companies to start planning about the application for the EUDAMED. Since the time to go live is near. They need to allocate budget for the resources that will be needed to submit the applications, and to manage their compliance, competencies with the new system.
TS Quality & Engineering can help companies in planning and preparing their EUDAMED application process, moreover the training on the test environment etc.