Eudamed Update: Actors module testing
EMERGO SUMMARY OF KEY POINTS:
- The Eudamed project is following its original schedule.
- The first module has been tested by users.
- The development of specific procedures by the Competent Authorities is outside the reach of the Commission, but this will just be as important as the development of Eudamed.
- Industry needs time for developing and testing their interfaces, and this could be set up by giving them access to the draft modules.
Actor’s module testing day
On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data.
Manufacturers, importers and Authorized Representatives need to enter their data in order to get their Single Registration Numbers (SRN). Sponsors also need to enter their data, but they are not formally referred to as “economic operators.” Distributors are currently not required to enter data into Eudamed.
The SRN uniquely identifies the economic operator within Eudamed. In order to get access to the database, the economic operator must appoint a local user. This must be done by their Local User Administrator (LUA), which is linked in the database by a CA.
The actor test consisted of creating an account for a manufacturer and an Authorized Representative, adding the LUA and making sure that these entries were validated by the CA. All testers were enabled to have that validating role, although in reality this of course will be limited to users related to the CAs.
Although there were some minor issues, it can be concluded that this module functions as needed. It only allows for manual data entry, which poses no problem because this type of data does not require high volumes or frequent updating. Most of the data entry processes followed an intuitive path, and most of the issues encountered by users had to do with inexperience with the system. Therefore it can be concluded that Eudamed has followed its initial schedule and the basic concept is acceptable.
The main challenge was found to be the validation process of the entered data. Competent Authorities need to allow an economic operator access to Eudamed by issuing an SRN and in a next step they must link at least one LUA to that SRN. When entering data this is a very simple process: Users just check “allow” or “reject.”
But of course there needs to be a procedure with specific criteria supporting this step. Access to Eudamed is part of the demonstration of conformity and therefore only correct entries should be allowed. CAs must assume their role as gate keepers by preventing fraudulent entries or legitimate companies’ identities being inappropriately used by others.
For EU-based actors this process is relatively straightforward. There are identifiers like the VAT number or the registration in the Trade Register, as well as social security numbers or other identifications for validating individuals. However, for non-EU manufacturers these sources may not always be available. And although the Authorized Representative has a role in validating the identity of the non-EU manufacturer, the validating step by the authorities should be independent and thorough. After all, supervision is a responsibility that cannot be outsourced to an economic operator. Obviously all Member States should have the same high level of scrutiny when it comes to issuing new SRNs and appointing new LUAs. It can be expected they will cooperate within the CAMD (Competent Authorities for Medical Devices) group to ensure this level playing field.
It speaks for itself that a thorough validation process will take time. Based on information by MedTech Europe, Emergo estimates there are about 25,000 European manufacturers and an equal number of non-EU manufacturers. These manufacturers are estimated to require about 20,000 importers and 10,000 Authorized Representatives.
On top of that, 50,000 manufacturers may use about 30,000 sponsors. This will result in an estimated total of 110,000 actors to be entered into Eudamed. It is recommended to appoint more than one LUA, because this person will be able to add new users and make fundamental changes to an account.
Emergo estimates the average company will appoint 2.5 LUAs. This would imply a total of 275,000 users. Of course these totals of 110,000 SRNs and 275,000 LUAs to be issued are estimates that may change, but they will probably provide an indication of the real data.
Furthermore, a hard Brexit will require British manufacturers using importers in the EU as well as Authorized Representatives, and therefore this event is likely to increase the number of users instead of limiting it.
These numbers will have to be processed by CAs, which will require some time. Some authorities have acknowledged this and started developing processes, but others appear not to have started. It speaks for itself that continuity of care can be negatively impacted if there are too many delays in this process
The module tested on April 12 only allowed for manual data entry. This was not seen as a major issue. But other modules will probably consiste entirely of machine-to-machine (M2M) interaction. M2M will allow the database of an actor to interact with Eudamed without human interference. This is expected to increase speed and accuracy of the data. There is a separate working group in Eudamed working on M2M tools.
Industry stakeholders are pushing the Eudamed team to provide insight into the database specifications so they can start working as soon as possible. Developing databases and interfaces takes a lot of time, and the developers need to start working as soon as possible now. The late introduction of M2M can also turn into a bottleneck because those large data sets cannot be manually processed.
But, having the specifications is not enough for developing M2M tools. There also need to be adequate testing facilities, which will probably be available after Eudamed’s introduction. But that may be too late for early implementation of M2M tools. The problem for the Commission is that Eudamed is planned to be launched as the whole package. The use of some modules for testing in advance is not possible. However, Eudamed will be fully operational at the moment the audit starts. The modules in that development stage could be used for testing and practicing and also to provide early feedback on workability. It could even be possible to have industry use this test environment to get temporary SRNs issued together with LUAs, all with full validation by the CAs, this test data can later easily be transferred to the official Eudamed site with a “light” validation.
Eudamed ready in time?
From this first test it appears quite likely Eudamed will be ready in 2020, although the deadline in March could be a bit too ambitious. This would help the implementation of the Regulations a lot. However, from this test it also became clear that having a working database will not be enough to guarantee its implementation. There are procedures and criteria that need to be developed by the CAs, and implemented in all Member States at the same high level. Also the actors need sufficient time for developing their M2M tools and interfaces to allow for high-speed and high-quality data entry. There are indications that behind the scenes negotiations take place to create these conditions.