Team Notified Body (NB) has scheduled another MDR training session for Wednesday, February 12, 2025. The full overview from Team NB is available: HERE

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.
  • i.e., optimal for EU-based individuals.
• The training is limited to 50 organizations.
• It is conducted virtually, with up to 2 separate connections per organization.
• Priority sign-up will be given to small-to-medium-sized enterprises (SMEs).
  • Twenty-five (25) spots will be held for SMEs.
  • SMEs have until Monday January 6, 2025 to sign up for the reserved spots.
• The fee is:
  • EUR 450 per SME
  • EUR 900 per non-SME organization
• A Certificate of attendance will be issued upon request.
• Download the PDF in the above link to obtain the bank details for payment.

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: General Safety and Performance Requirements (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)
  • Common nonconformities
• 16.30-17.00 – Closing session
  • Last questions, feedback, and suggestions

There will be multiple opportunities for Q&A throughout.