Skip to main content
RAPS Euro Convergence 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
ViewAttendees 30

Medical Devices

Domain: Regulatory Frameworks & Strategy

Knowledge Area: Data Management & Analysis

Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication

Friday, May 12, 2023
15:30 – 16:30 CEST
Location: Pearl 1

Supported By
Description: The EU Commission has requested their Medical Device Coordination Group to propose possible solutions to increase the review capacity at MDR and IVDR designated Notified Bodies to address the increasing loud calls from Healthcare providers and industry that existing products will not be certified before end of the transition dates, as a result of MDR induced bottlenecks during review of technical documentation and audits.
This has resulted in MDCG 2022-14 position paper with specific actions that can result in more technical dossiers being reviewed and more audits being performed.
During this panel discussion with representatives from 3 large Notified Bodies, the first feedback on the impact of a number of specific actions on review and audit time will be discussed and shared with the audience. Any intermediate publications on the impact from for example Team-NB and industry associations on these subjects will be taken into account.
At the end of the panel discussion (45 minutes), 15 minutes of interactive discussion with the audience is planned for.

Learning Objectives:

  • Understand the impact of the MDCG proposals on internal processes at NB’s, such as focus points during reviews/audits, qualification of reviewers/auditors, etc.
  • Obtain the latest insights in the effectiveness of the proposed actions, in case measurable data can / will / has been shared.
  • Being able to ask specific questions to NB representatives on their personal experiences with the proposed actions.