Registration Fees & Deadlines
495 € for SMEs – Priority for SMEs registration (25 places reserved) until February 28th
990 € for organisation
You can register until March 27thth
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 MDR 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 MDR (version 3—published on April 9th, 2025
The topics are presented by MDR experts of designated notified bodies.
The content has been developed and is presented by MDR experts from members of 11 notified bodies, namely BSI, CeCert, CeCertiso, Dekra, DNV, ECM, GMED, NSAI, SGS, TÜV Rheinland, TÜV SÜD.
PROGRAM
| 09.00 – 09.30 | Welcome and logistic information | |
| 09.30 – 10.15 | Structure of Technical Documentation | |
| Alessandro Nicoletti, Entercerma | ||
| David Burke, NSAI | ||
| Purvi Patel, BSI | ||
| Sebastian Sowiński, Ce Cert | ||
| Virginie Siloret, SGS Belgium | ||
| 10.15 – 10.30 | Break | |
| 10.30 – 12.00 | MDR Annex II Sections 1-3 | |
| Alexandra Seber, TÜV SÜD | ||
| Annapoorna Rajan, Dekra NL | ||
| Virginie Siloret, SGS Belgium | ||
| Yannick Peron, BSI | ||
| 12:00 – 13:15 | Lunch | |
| 13.15 – 14.45 | MDR Annex II Sections 4-6 (excluding clinical data) | |
| Amy Chan, GMED | ||
| Andreas Klotz, TÜV SÜD | ||
| Christoph Ziskoven, TÜV Rheinland | ||
| Lisa Moloney, BSI | ||
| Regine Großkopf-Lüdemann, TÜV Rheinland | ||
| 14.45 – 15.00 | Break | |
| 15.00 – 16.30 | MDR Annex II Section 6 (clinical data) and An-nex III (post-market surveillance) | |
| Ágnes Horvath, CE Certiso | ||
| Alexey Shiryaev, DNV | ||
| Anna Pietersma, Dekra NL | ||
| Breda Kearney, BSI | ||
| Maria Karakitsou, SGS Belgium | ||
| Nunung Nur Rahmah, Dekra NL | ||
| 16.30 – 17.00 | Closing session | |