Europe’s Eudamed Database: Five Key Questions (Part 1)
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices
Compliance with Eudamed database requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) may be years away, but preparation for the new requirements will take sustained effort. We've identified key issues many manufacturers are dealing with ahead of Eudamed's launch.
In July 2018 Emergo presented a webinar on Eudamed that generated more than 100 questions from audience members. We’ve distilled these questions and concerns regarding the European medical device database into five major themes, which we cover in a two-part blog post series.
Single Registration Number (SRN) and Local User Administrator (LUA)
The SRN is a code used for unambiguous identification of an economic operator within the EU. Identification codes used for other markets (e.g., GS1 GLN) are not relevant in this context.
Distributors do not need to enter data in Eudamed and therefore are not required to apply for an SRN. Sponsors are not considered economic operators, so for formal reasons they will not be identified by an SRN but by an identification number. In practice there will not be a significant difference between these two, so where applicable the below information should also be considered relevant for the sponsor.
An organization needs one SRN per actor role. Some examples: Manufacturer Alpha is based in one of the EU Member States and they also import devices from non-EU manufacturer Beta. They need one SRN for their role as manufacturer and another for their role as importer. Should they also take care of the role of the Authorized Representative (AR) for the devices of Beta, they would require a third SRN.
If a manufacturer has multiple sites, they still need only one SRN, unless these sites are mentioned on the label (and certificate, IFU etc.) as different legal manufacturers. An AR representing twelve non-EU manufacturers needs one SRN, because the AR is fulfilling the same role for each of those manufacturers. Each SRN is linked to a specific role, and therefore each SRN will have different authorities regarding data entry and access to specific records.
When requesting an SRN,the LUA must also be appointed. The LUA can authorize local users within an SRN, which makes it important position within the Eudamed system. There is no limit to the number of users the LUA can appoint, and users may have different access levels. In order to ensure continuity, the European Commission recommends the appointment of more than one LUA. Expect the identity of the LUA to be verified by the Competent Authorities. It is not decided how these verifications will be done. It is important that each actor requests their SRN themselves, because the Medical Devices Regulation and In-vitro Diagnostic Regulation do not allow delegation of this step; you can only ask for an SRN for Company XYZ if you are Company XYZ. The AR may help and guide a non-EU company through the steps, but companies themselves must perform this step.
The SRN and LUA will be issued/appointed by the relevant National Competent Authority. For EU-based organizations this is the Competent Authority of the Member State where they are based. For non-EU manufacturers this will be the Member State where their AR is based, and for non-EU sponsors this will be the Member State where their Legal Representative is based. At this moment it is not possible to request an SRN or get a LUA appointed. Still, Emergo recommends that you approach your local Competent Authority or that of your AR by sending a registered letter to their general mail address.
There are two very good reasons for this:
- You make them aware you want this, and you want this now. At this moment Competent Authorities not developed these procedures, although it does not require much imagination to understand that issuing all these SRNs and LUAs between March 2020 and May 2020 will be an enormous challenge. If they wait too long, they will not be ready for this once Eudamed goes live. Although the MDR allows for a delay in the requirements related to Eudamed if the development of Eudamed is delayed, there are no provisions in case of a bottleneck in the issuing of SRNs by the authorities.
- There is also a legal point; if you claim damage because your SRN was not issued in time, you can demonstrate that you have made the authorities aware of your need for an SRN. This will make your case strong, and the authorities will be aware of that. This may help the authorities in setting priorities in time.
For British companies it is not clear how the situation will be after 29 March 2019 (Brexit day). However, except for the hard ‘cliff edge’ scenario it is likely the MDR will be introduced into British law as well. Therefore it is recommended for British companies to prepare for Eudamed as well.
SRN/LUA in short:
- One SRN for each role.
- Request SRN and LUA yourselves.
- Approach your local Competent Authority, or that of your AR for requesting an SRN/LUA.
- Send a registered letter to your Competent Authority now asking for an SRN/LUA.
Timelines for Eudamed and related data entry deadlines
Eudamed will be developed for medical devices as well as for IVDs. As the IVDR becomes applicable two years after the MDR, the MDR gets a lot of attention. Therefore it may appear as if the focus is only on medical devices. However, at the moment Eudamed goes live it will be available for IVDs as well.
The current timelines indicate that Eudamed will go live on March 26, 2020. This may sound optimistic, but so far the Eudamed team has managed to hit all deadlines and it appears they are still on track for that ambitious goal.
From the day Eudamed goes live it is possible to request an SRN and have an LUA appointed. Once that is done each actor can enter their data into Eudamed.
Unless the go-live date of Eudamed is delayed beyond 26 May 26, 2020, the date of application of the MDR will require manufacturers of medical devices (not IVDs) to start entering data into Eudamed. For the first 18 months the requirement is limited to new information. In general this means that any vigilance case, Field Safety Corrective Action (FSCA), new or changed certificate, new clinical study, etc. needs to be entered in Eudamed. That also implies that all related information needs to be entered: device details (including UDI), certificates, etc. This will help fill Eudamed with data. Of course manufacturers need to have access to Eudamed and therefore the issuing of SRN and appointment of LUA is crucial.
During an 18-month periodafter the application of Eudamed, all data related to the other medical devices manufacturers are placing on the European market must be entered. This includes devices that are certified under the current Medical Devices Directive (MDD). Until devices are registered in Eudamed, the current MDD requirements for registration/notification are presumed to be in place.
For IVDs the situation is generally the same. From the moment Eudamed goes live manufacturers can apply for an SRN and have their LUA appointed. They can start entering data any time after that. From May 26, 2022, the date of application of the IVDR, they must enter new or mutated data and Eudamed must be fully up to date will all data regarding IVDs being placed on the market 18 months later.
Timelines in short:
- The go-live date for Eudamed is set on March 26, 2020.
- On that date Eudamed will be functional for medical devices as well as IVDs.
- From 26 May 26, 2020 for medical devices, and May 26, 2022 for IVDs, it is required to enter new or modified data in Eudamed, including data that is directly linked to these records.
- During a period of 18 months after the date of application of Eudamed the database must be filled with data on the rest of the devices that are placed on the European market.
Ronald Boumans is Senior Regulatory Consultant at Emergo in The Netherlands.
Learn more about Eudamed and European medical device regulatory issues at Emergo:
- EU MDR 2017.745 gap assessment and transition management
- On-site MDR training for medical device companies
- Webinar: Eudamed requirements under the European MDR and IVDR