Clinical trial safety reporting, Eudamed start dates

25 May 2020


u.k.

The European Commission’s Medical Device Coordination Group published guidance Wednesday on reporting safety events involving investigational devices under the incoming regulations. The document said sponsors will use a new template to file safety reports in the period between the Medical Device Regulation coming into force and the linked Eudamed database going live.

In a separate update this week, the EC laid out the current status of ongoing guidance development within MDCG subgroups on more than 40 topics related to MDR, IVDR, or both. Of the many deliverables slated for MDCG endorsement in 2020, two relate to Eudamed: a guidance on harmonised administrative practices and alternative technical solutions, and a position paper on the use of SRN (single registration number).

The Commission last year delayed the introduction of its database of medical device information until May 2022 after coming to accept it would miss its original target. Since then, EU authorities have delayed the date of application for MDR until 2021, but that still leaves a 12-month window in which the new regulations will be in force in the absence of a database intended to be key to their functioning.

On Wednesday, MDCG cleared up how one aspect of MDR will work prior to the Eudamed launch. The guidance states sponsors will use “a new template for the Summary Reporting Form” to share details of certain adverse events and product deficiencies linked to their investigational devices.

It will be impossible to generate the EU-wide Single Identification Numbers referenced in MDR until Eudamed is fully functional, leading MDCG to propose assigning tracking numbers to clinical trials when they are registered in the existing medical device databank. Sponsors will then use the tracking numbers, known as CIV IDs, to identify clinical trials in safety reports.

The guidance details the information MDCG expects sponsors to include in reports and touches on what will happen when Eudamed belatedly goes live. Once the Commission has formally confirmed Eudamed to be fully functional, sponsors will have six months to start reporting via the database.

Even with that transition period, MDCG acknowledges that some reports filed using the Summary Reporting Form will remain active at the point that Eudamed becomes mandatory. Sponsors in that position will continue to use the old process to file follow-up events and final reports, but must use Eudamed for wholly new submissions.

It is unclear whether events submitted using a Summary Reporting Form in the possible 18-month window between the MDR date of application and Eudamed becoming mandatory will ever become part of the database. In theory, events filed before Eudamed becomes mandatory could be added to the database retrospectively. However, MDCG said it is unclear whether that will be possible.


Published by medtechdive.com on May 14, 2020
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