MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 

This guidance addresses safety reporting in clinical investigations of medical devices in line with the requirements of the MDR Article 80(2).

The document further states that the reporting modalities and format set out apply to:

  • Pre-market clinical investigations covered by Articles 62 and 74(2) of the MDR conducted with:
    • a) Non-CE marked devices,
    • b) CE marked devices used outside the intended use(s) covered by the CE-marking.
    • c) The term pre-market clinical investigation may also include some studies covered by MDR Article 82.
  • Post-Market Clinical Follow Up (PMCF) investigations that involve procedures additional to those performed under the normal conditions of use of the device, and where those additional procedures imposed by the clinical investigation plan are invasive or burdensome, covered by MDR Article 74(1).
  • Other post-market clinical investigations due to national requirements following MDR Article 82.
  • Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC (AIMDD) or Article 15 of Directive 93/42/EEC (MDD) prior to 26 May 2021. These investigations may continue to be conducted after date of application of the MDR, but the reporting of serious adverse events and device deficiencies shall be carried out in accordance with the MDR requirements from 26 May 2021 and onwards.

Once Eudamed is available and fully functional the obligations and requirements that relate to performing safety reporting via Eudamed shall apply from the date corresponding to six months after the date of publication of the notice that Eudamed is ready.

The guidance further states that “It is acknowledged that at the time of transition to reporting via Eudamed, there will be ongoing events for which initial reports have been made according to the procedures described in this document. For these reportable events follow-up and final reports will be submitted to the National Competent Authorities by the same procedure, but all new reportable events shall be entered in Eudamed. Whether retrospective uploading of previous event reports to Eudamed will be possible is not clear at the time this guidance is issued.”

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0

A new template for the Summary Reporting Form should be used for all studies from 26 May 2021 onwards. The tabular format needs to be filled in/updated for each reportable event or for new findings/updates to already reported events. It shall be transmitted to all National Competent Authorities where the clinical investigation is being performed.

What does this mean to you?

Sponsors of clinical investigations should read this guidance carefully to understand their obligations as soon as MDR enters into force and to understand how safety reporting of clinical investigations should be done under the MDR.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us

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