Device Supply Disruption: Updated Reporting Process in France starting September 1, 2024
7 July 2024
Team Notified Body: Transfer Agreement for Surveillance of MDD/AIMDD Legacy Devices Updated
8 July 2024Table of Contents
Team Notified Body (NB) has scheduled another MDR training session for Wednesday November 6, 2024. 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 October 4, 2024 to sign up for the reserved spots.
- The fee is:
- EUR 450 per SME
- EUR 900 per non-SME organisation
- 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: 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.
