Registration Fees & Deadlines
600 € for SMEs – Priority for SMEs registration (25 places reserved) until April 24th
1200 € for organisation
You can register until June 1st
Event Summary
The MDCG Position Paper Transition to the MDR and IVDR (MDCG 2022-14) encourages notified bodies to strengthen the communication with manufacturers by means of webinars, workshops, targeted feedback and informative sessions
The aim of this training is to review the IVDR requirements related to Technical Documentation and share notified bodies insights;
; it is also planned to review the Team NB Technical Documentation Best Practice document for IVDR (published on March 1st 2023).
The topics are presented by IVD experts of IVDR designated notified bodies. The content was elaborated by IVD experts of 7 notified bodies, namely BSI, Dekra B.V., Dekra GmbH, GMED, NSAI, TÜV Rheinland LGA and TÜV SÜD.
PROGRAM
| 09.00 – 09.30 | Welcome of participants | |
| 09.30 – 10.45 | The (pre) application phase | |
| Q&A moderated IVD expert | ||
| 10.45 – 11.00 | Break | |
| 11.00 – 12.15 | Directive to Regulation data | |
| Q&A moderated IVD expert | ||
| 12:15 – 13:30 | Lunch | |
| 13.30 – 14.45 | Performance Evaluation | |
| Q&A moderated IVD expert | ||
| 14.45 – 15.00 | Break | |
| 15.00 – 16.15 | Post market surveillance and PMCF | |
| Q&A moderated IVD expert | ||
| 16.15 – 17.00 | Closing session | |