MDR Clinical Training for Manufacturers
2026-02-26 13:30 - 17:30 (Europe/Paris) | Remotely
Registration Fees & Deadlines
275 € for SMEs – Priority for SMEs registration (25 places reserved) until December 31st
550 € for organisation
You can register until : SOLD OUT

Event Summary
Clinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples.

This training is directed towards manufacturers/participants who already have experience in creating CER and/or are involved in CE submission. Therefore, the training will focus more on real cases examples and less on introduction or citing regulations.
The topics are presented by MDR experts of designated notified bodies.

The content was elaborated by MDR experts of 3 notified bodies, namely BSI, CeCertiso, Dekra.

This training is intended for participants who are members of a manufacturer’s clinical team and have experience in creating CERs and/or are involved in CE submission. Therefore, can you consider this exper-tise for registrations.

PROGRAM

13.30 – 13.45

Welcome and logistic information

13.45 – 14.35

Clinical evaluation routes

Ágnes Horvath, CE Certiso

14.35 – 15.25

How to build sufficient clinical evidence?

Nunung Nur Rahmah, Dekra NL

15.25 – 15.40

Break

15.40 – 16.30

Post market surveillance and PMCF

Breda Kearney, BSI

16.30– 17.00

Q&A session

17.00 – 17.30

Closing session

MDR Technical Documentation Training for Manufacturers
2026-04-29 09:00 - 17:00
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

REGISTRATION
