The European Commission recently announced it would delay the launch of the European Database on Medical Devices (EUDAMED) for two years. This announcement came after the European Commission determined the planned staggered launch would impact database functionality.
The first half of the database was set to launch in March 2020, shortly before the full implementation of the European Union (EU) Medical Device Regulation (MDR) on May 26, 2020. The second half was due to launch March 2022 in advance of the In Vitro Diagnostic Regulation (IVDR).
However, at the end of October 2019, the European Commission concluded that full database functionality was necessary to make EUDAMED operational. As such, both parts of the database will now launch simultaneously on May 26, 2022, once all modules are up and running, and the database has been subjected to an independent audit.
The delay may also impact the notified body approval process, as notified bodies are expected to use the database during this process.
Additional Time to Meet Data Requirements
Ahead of the European Commission’s announcement, members of the medical devices industry expressed skepticism of the March 2020 deadline, citing concerns over IT systems having to align with the database’s final specifications, which had only been finalized in February 2019.
The extra two years offered by the delay will provide companies additional time to ensure their IT systems are aligned with the EUDAMED system, and the data they collect and present is complete and accurate.
The delay is not a reprieve from the looming EU MDR deadline, however, and companies must still conduct certain EUDAMED-related activities, even if they have no need to report this data electronically.
To learn more about data requirements under the EU Medical Device Regulation, download our guide.
Uncertainty Over Timelines
Article 123(3)(d) in the MDR legal text states “the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice” in the Official Journal of the European Union. The legal text also grants an 18-month transition period in Article 123(3)(e), which has caused some confusion.
The Medical Device Coordination Group provided guidance to address this confusion, stating that EUDAMED registration obligations apply “18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice.”
Impact of the EUDAMED Delay on the MDR
While the actual electronic reporting of certain tasks remains unchanged, companies still need to conduct certain activities in the MDR schedule, including Period Safety Update Reports (PSURs) and Safety and Clinical Performance Reports (SSCPs).
EUDAMED submissions require companies to collect, manage and maintain accurate substance data. A comprehensive supply chain data management solution such as the Assent Compliance Platform can help companies collect and manage the data they need to meet their requirements under regulations such as the EU MDR. Contact us to learn more.