Team Notified Body (NB) has scheduled a third IVDR training session for Thursday, February 1, 2024. The details are available: HERE

The first two sessions are now fully booked, resulting in a third session being scheduled.

The aim of the training is to review the IVDR requirements related to Technical Documentation and share Notified Body insights. As well, to review the Team NB Technical Documentation Best Practice guidance document.

Training Details

• • The training is organized by Team NB, and the content was developed by BSI, Dekra B.V., Dekra GmbH, GMED, NSAI, TUV Rheinland LGA and TUV SUD.
  • The training time is 9:00 – 17:00 Central European Time.
  • The training is limited to 40 organizations, with up to 2 separate connections per organization.
  • Priority sign-up will be given to small-to-medium-sized enterprises (SME) until Thursday, January 4, 2024. Twenty (20) places will be held for SMEs.
  • The fee is:
    • EUR 450 per SME
    • • EUR 900 per non-SME organisation
  • The training is remote.
  • A training attendance certificate will be issued.

You can register for the training session: HERE

Legacy Device Change Assessment Tool

Confirm if your MDD/AIMDD/IVDD device change is non-significant, allowing it to maintain its legacy status. Or if the change is significant and requires MDR/IVDR CE Marking.

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Training Agenda

• • 9.00 to 9.30 – Welcome
  • 9.30 to 10.45 – The (pre) application phase
    • • Structure of a TD file, NB code assignment, classification, creation of sampling groups
  • 11.00-12.15 – Directive to Regulation data
    • • Completion of a gap assessment, tips & tricks, state of the art concept
  • 13.30 to 14.45 – Performance Evaluation
    • • How to demonstrate Performance Evaluation
  • 15.00-16.15 – Clinical Evidence and Post Market Surveillance
    • • IVDR requirements & NB insights
  • 16.15-17.00 – Closing session
    • • Summary of main elements, last questions, feedback and suggestions

There will be multiple opportunities for Q&A throughout.