May 12, 2020

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official Eudamed date of application in May 2022.

In this way it becomes possible for economic operators to start using Eudamed before they are legally required to do so. This will help companies to prepare and will also help the authorities to smooth out unforeseen issues before the date of application.

Latest Eudamed compliance timelines

At this moment the European Commission applies the following timeline:

  • The Actor Registration module will become available not later than March 2021. This module will allow for manufacturers, authorized representatives, importers as well as systems and procedure pack producers to enter their data in Eudamed and to acquire a Single Registration Number (SRN). The SRN will be needed for declarations of conformity and certificates, and therefore the availability of SRNs is considered very important for the proper functioning of the MDR. It is important that the SRN can be obtained before the date of application of the MDR.
  • In May 2021 two other modules are expected: the UDI/Device Registration module and the Certificate/Notified Body module. These two modules are also required for data entry, and to allow for data on certificates.
  • Other modules on clinical investigations, incident reporting and market surveillance can be released later because they are intended as tools for communication about cases. Current systems can and will be used for such communications until Eudamed is fully functional.

Of course, European regulators should provide additional guidance around the above dates about whether these entries are “voluntary” or mandatory. In theory, an economic operator should be allowed to register only after Eudamed has become applicable in May 2022. However, Notified Bodies are already asking manufacturers to supply their SRN, so authorities should specify clearly what data is mandatory, and when.

Although Eudamed implementation still appears as something far into the future, manufacturers will be able to start uploading data into Eudamed within a year. This should signal to all companies involved that they need to start preparing now (if they haven’t already). Eudamed requires a careful rethinking of how a company identifies and describes its device; any changes that result from that rethinking will take time to implement.

Learn more about Eudamed and European MDR compliance at Emergo by UL:

Author

  • Ronald Boumans

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