UPDATE: Third session fully booked, 4th session scheduled

On December 6, 2023, Team NB announced that the training session discussed in the original post (below) is fully booked. Therefore, they have opened up a fourth MDR training session on Wednesday March 27, 2024. 

The agenda and pricing is the same for the new (4th) session.

• Details are available: HERE
• You can register for the training: HERE

Like the previous sessionss, 25 places will be reserved for SMEs until Monday February 26, 2023.

Original Post

Team Notified Body (NB) has scheduled a third MDR training session for Wednesday, February 7, 2024. The details are available: HERE

This is a great opportunity to engage directly with Notified Body experts.

If you are not able to attend the training being given on December 14, 2023, this is another opportunity. That said, like the previous sessions, the timing is primarily optimal for EU-based companies.

Training Details

• • The training is organized by Team NB, and the content was developed by BSI, CeCertiso, Dekra, DNV, ECM, GMED, SGS, TÜV Rheinland, and TÜV SÜD.
  • The training time is 9:00 – 17:00 Central European Time.
  • The training is limited to 50 organizations, with up to 2 separate connections per organization.
  • Priority sign-up will be given to small-to-medium-sized enterprises (SME) until Monday, January 8, 2024. Twenty-five (25) spots will be held for SMEs.
  • The fee is:
    • EUR 450 per SME
    • EUR 900 per non-SME organisation
  • A training attendance certificate will be issued upon request.

You can register for the training session: HERE

Training Agenda

• • 9.00 to 9.30 – Welcome and logistic information
  • 9.30 to 10.15 – Structure of Technical Documentation
    • Focus on documents/information commonly missing or unclear
  • 10.30-12.00 – MDR Annex II Sections 1-3
    • Common nonconformities: device description and specification, information to be supplied by the manufacturer (i.e., labeling), design and manufacturing information.
  • 13.15 to 14.45 – MDR Annex II Sections 4
    • Common nonconformities: GSPRs, benefit-risk and risk management, pre-clinical data
  • 15.00-16.30 – MDR Annex II Section 6 (clinical data) and Annex III (post-market surveillance)
  • 16.30-17.00 – Closing session

There will be multiple opportunities for Q&A throughout.