The European Commission has delayed the launch of the European Database on Medical Devices (Eudamed) because the database is not yet fully functional. The delay will give medical device manufacturers distributing products in Europe an additional two years to ensure their IT systems can function with the EUDAMED system. This is good news for some medical device manufacturers because of concern over whether their IT systems would work with the Eudamed. The specifications for the database were finalized in February 2019.
EUDAMED 2019 Delay Schedule
Keep in mind, companies must still complete some Eudamed related tasks by the March 2020 deadline. Below is a summary of the EU MD/IVDR related delays to date.
Eudamed Delay until 26 May 2022
Central to the implementation of the MDR/IVDR is the development and implementation of the new Eudamed database (though this is technically version 3 – because of the many changes and the new significant public interface, it is simply being called Eudamed). The new Eudamed is intended to “…improve transparency and coordination of information regarding medical devices available on the EU market.” Though originally the European Commission (EC) had envisioned deploying Eudamed in modules and phases, the Commission ultimately decided that it was really only practical to make Eudamed operational in totality – once all of its various modules (e.g., actors, UDI and device registration, NBs/certificates, vigilance, post market surveillance) were full functionality. Therefore, Eudamed’s official launch has been delayed until 26 May 2022 (coinciding with the date of application of the IVDR). It is critical to note, however, that the original date of application of the MDR remains 26 May 2020
. Moreover, it is important to note that the requirements that include a Eudamed submission still apply, even though the act of submitting the information is delayed.
for more information.
Class I Reusable Surgical Instruments:
On 16 December 2019, the EU Parliament adopted the second Corrigendum to the MDR/IVDR. Among the changes is an “exception,” which enables certain class I devices to leverage the same transitional provisions that exist for class IIa/b and III devices. Specifically, it provides that certain class I devices, which have a declaration of conformity drawn up prior to 26 May 2020 and for which the MDR requires a conformity assessment procedure involving a notified body (that is, class I devices that are sterile, have a measuring function, or are reusable surgical instruments) … may continue to be placed on the market or put into service until 26 May 2024. That is, the devices do not need to be fully MDR compliant until 26 May 2024. However, as with the other transitional provisions, these additional requirements apply:
- The medical devices continue to comply with the relevant Directive,
- There must be no significant changes in the design and intended purpose of the medical devices, and
- The devices must meet the requirements of the MDR related to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.
for more information