Quality & complianceOfficial

Commission publishes recording of webinar on two years of pilot coordinated assessment for device studies

🇪🇺 European Commission (DG SANTE) · Fri 13 Nov 2026

DG SANTE reports positive feedback from sponsors and Member States on the pilot for clinical investigations and performance studies under the MDR and IVDR, with more than 200 attending.

The European Commission's health directorate-general has put online the recording of a webinar on its pilot coordinated assessment for medical devices and in vitro diagnostic medical devices. The event took place on 6 November for sponsors and national competent authorities and drew more than 200 participants.

The session looked back on the first two years of the pilot, which covers coordinated assessment of clinical investigations and performance studies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Sponsors that completed their assessments under the first call presented feedback, alongside the reporting Member States.

According to the Commission, the overall feedback was positive. It pointed to better cooperation and efficiency, as well as shorter assessment timelines. The announcement does not give figures, such as the number of studies assessed or the size of any time savings.

The Commission also described the webinar as a forum to encourage future sponsors to join the pilot. The page hosting the recording links to further material, including a page on the pilot, an expression of interest form for sponsors and a questions-and-answers document.

What it means for your team

  • Sponsors planning clinical investigations or performance studies in several Member States may wish to review the recording and the expression of interest form to judge whether the pilot suits their programmes.
  • National competent authority staff and regulatory teams can use the recording to hear the reported experience of sponsors and reporting Member States.
  • The positive feedback is self-reported by the Commission and carries no published metrics, so teams should check the Q&A and pilot pages before drawing conclusions on timelines.

Official source: European Commission (DG SANTE) ↗

Article written by VigiEye from the official source (European Commission (DG SANTE)). AI-assisted; check the source before acting.

More Quality & compliance All →