Team Notified Body MDR Training: April 2024

Table of Contents

Team Notified Body (NB) has scheduled another MDR training session for Monday, 29 April 2024. These sessions tend to sell out quickly.

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 (SME).
- Twenty-five (25) spots will be held for SMEs.
- SMEs have until Friday, 29 March 2024 to sign up for the reserved spots.
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

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)
- Common nonconformities
16.30-17.00 – Closing session
- Last questions, feedback, and suggestions

There will be multiple opportunities for Q&A throughout.