With MDR nearing, EU updates guidance on transition to Eudamed database

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  • With MDR nearing, EU updates guidance on transition to Eudamed database

With MDR nearing, EU updates guidance on transition to Eudamed database

Dive Brief:

  • The Medical Device Coordination Group (MDCG) has updated its guidance on the practices European countries should follow until the Eudamed database goes live.
  • With Eudamed set to come online one year after the Medical Device Regulation takes effect, MDCG released a guide to interim practices and technical solutions in February. Now, with weeks to go until the start of MDR on May 26, the group has updated its guidance.
  • The main change is the deletion of a line that said Eudamed reporting obligations must be carried out as soon as the database becomes fully functional.

Dive Insight:

The timelines for implementing Eudamed and fully starting MDR fell out of sync late in 2019 when the European Commission delayed the introduction of the database by at least two years. As the COVID-19 crisis escalated, the European Union pushed back the MDR date of application by one year but that still meant the rules would take effect before the full launch of the database.

MDCG set out how EU countries should manage the transition earlier this year. However, in updating the text, MDCG has deleted the following line: “Parties should also note that, in principle and unless otherwise concluded by the MDCG, the reporting obligations with regard to Eudamed apply to all information generated and collected under the MDR from its date of application (e.g. UDI, certificates) and therefore must be carried out as soon as Eudamed becomes fully functional.”

Most of the rest of the document is unchanged. As such, the guidance still states that the proposed practices and solutions do not affect general obligations to comply with MDR. Rather, the proposals are intended to enable EU countries and other parties to meet their MDR obligations without putting them under unnecessary additional burdens.

The proposals themselves are unchanged. In a table, it lists MDR provisions related to the use of the database alongside alternative ways to submit or exchange information in compliance with the rules.

For example, one part of the table contains the MDR section about making the summary of safety and clinical performance (SCCP) available to the public via Eudamed. As that will not be possible on the day MDR takes effect, MDCG said “the SSCP shall be made available to the public upon request without undue delay or the manufacturer shall specify where it is made available to the public.”

MDCG wants notified bodies to upload SSCPs to Eudamed as soon as the functionality is available, even if the Commission is yet to publish a notice confirming the full system is operational. The group made the same request about other temporary measures, reflecting the plan to make different parts of Eudamed available when they are ready, rather than waiting for the completion of the full system.

The Eudamed module on Actor registration went live in December. The Commission expects two more modules, on UDI/device registration and Certificates and Notified Bodies, to come online in September.