Aug 8, 2018

In Part Two of Emergo’s series identifying five major questions regarding Eudamed compliance under Europe’s Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR), we cover issues including roles and responsibilities of importers, distributors and Authorized Representatives, plus clinical and performance study issues.

Eudamed: Top 5 questions for medical device and IVD companies part 2In 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. (Read Part One here.)

Role of importers, distributors and AR

A manufacturer may distribute its devices directly to end users. The majority of manufacturers will however use distributors. Distributors will not have to enter data in Eudamed, but they should access the database to verify that their device information is entered correctly. If that is not the case, the device is not in compliance and they should not distribute it further in Europe.

Manufacturers based outside the EU must use an importer. This importer is a distributor that gets its devices from a manufacturer based outside the EU and then places these products on the European market. The role of the importer is slightly different from that of the distributor (see articles 13 and 14 of the MDR and IVDR). The importer must register itself in Eudamed and apply for a Single Registration Number (SRN) appoint a Local User Administrator (LUA).

Some non-EU companies have their own Authorized Representatives (AR), which also operate as their importers. These roles require different SRNs and cannot fall under the SRN of the manufacturer. Although in practice these steps may be taken by someone based in the manufacturer’s head office, it is very important to make sure such activities are performed by the respective legal persons: Manufacturer XYZ Ltd. uses XYZ Europe Ltd. as their AR, and XYZ Imports Ltd. for importing. Each of these entities must have its own respective SRN.

For non-EU manufacturers using an independent AR and importer, this works basically the same way. Each of these entities must have its own SRN. Both AR and importer may already have an SRN because they are involved with other devices, and they do not require an additional SRN for an extra manufacturer they are representing. The AR and/or importer may assist the manufacturer in getting access to Eudamed and entering data, but they cannot replace the manufacturer’s position. If this AR or importer enters data on behalf of the manufacturer, they must use the SRN of the manufacturer. If they would use their own SRN they would not be able to enter that data. The LUA of the manufacturer must therefore appoint users within the AR or importer. At this moment there is ongoing discussion as to whether the manufacturer may delegate data entry in the vigilance module to the AR. If that would become possible, the AR could enter vigilance information under its own SRN.

Importer, distributor and AR in short:

  • The importer must enter data in Eudamed, this is not required from the distributor.
  •  Manufacturers, importers and ARs must each have their own SRN that gives each of them specific authorities regarding data entry.
  • It is possible for a manufacturer to have others enter data by authorizing them to use his SRN.

Clinical studies and performance studies

Clinical studies are used to investigate the performance and safety of medical devices, while  performance studies investigate the performance of IVDs. Regarding Eudamed, these two types of studies are basically treated the same.

These studies are performed for devices that are not CE-marked, or with CE-marked devices applied outside their intended use. These devices are used on real patients, but they are not CE-marked. This also implies that the information one would expect from a CE-marked device will not be available in Eudamed. Therefore this module is used to make specific information available to the authorities and the public. Another consequence is that studies done outside Europe or previous studies do not require entering into Eudamed.

Information must be entered by the study sponsor. This sponsor can authorize others, like a contract research organization (CRO) or their legal representative, to enter data as well. This must be done by giving them access to the sponsor’s SRN.

Eudamed requires all relevant data to be entered. It is not possible to refer to other databases like Clinicaltrials.gov for that information.

Post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) studies, investigations done with CE-marked devices within the scope of their intended purpose, require subjects to be submitted to invasive or burdensome procedures in addition to those performed under normal conditions of use of a devices. These studies also require submitting information to Eudamed (see article 74 for details). Details regarding other PMCF or PMPF studies do not require uploading into Eudamed.

Studies in short:

  • Only clinical studies or performance studies that are ongoing or starting in Europe need to be entered into Eudamed.
  • The sponsor is responsible for entering data, but it can give others access to its SRN for doing this.
  • Full data entry is necessary; no reference to other databases is allowed.

Test environment

The test environment is not yet available. Once this is the case this will be communicated by the Commission and Emergo will of course forward that information. Emergo expects the test environment to be available somewhere in the middle of 2019.

For accessing the test environment it is not necessary to have an SRN. This environment will be available to users outside Europe as well. Users testing can switch between roles. For example, if a manufacturer wants to see how linking a certificate to a device works, it can enter fictional certificate data as if it were a Notified Body. The test environment can be used for testing and training for manual data entry and for machine-to-machine exchanges.

Test environment in short:

  • The test environment is not yet available.
  • Once available it will be open to anybody.
  • This site can also be used for training purposes.

Other Eudamed questions

Other Eudamed questions stemming from the webinar were very diverse. Some answers can be found by going back to the recorded webinar, others can be found in the MDR because the questions refer to the MDR requirements and are not specifically referring to Eudamed.

However, two issues were too important to be left unaddressed:

  1. Nomenclature: no decision has been taken regarding medical devices nomenclature. Therefore it is not possible to say anything about the future of Global Medical Device Nomenclature (GMDN). That is really all that can be said at this stage.
  2. Developing applications: if Eudamed goes live as planned in March 2020, it is important to develop and implement Eudamed applications in 2019. Although it is in this stage difficult to provide a clear indication of what such project require, it is clear Eudamed will influence how a manufacturer organizes its device’s data and regulatory affairs processes. Therefore manufacturers, but also importers and ARs, need to plan big and make sure sufficient budget is available.

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