MDR Technical Documentation Training for Manufacturers
2026-04-29 09:00 - 17:00 (Europe/Paris) | Remotely
Registration Fees & Deadlines
495 € for SMEs – Priority for SMEs registration (25 places reserved) until February 28th
990 € for organisation
You can register until April 10th
REGISTRATION

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

MDR Clinical Training for Manufacturers
2026-05-28 09:00 - 16:30 | Remotely
Registration Fees & Deadlines
600 € for SMEs – Priority for SMEs registration (25 places reserved) until March 27th
1200 € for organisation
You can register until April 28th

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

09.00 – 09.30

Welcome and logistic information

09.30 – 10.45

Clinical evaluation routes

Ágnes Horvath, CE Certiso

10.45 – 11.00

Break

11.00 – 12.30

How to build sufficient clinical evidence?

Nunung Nur Rahmah, Dekra NL

12:30 – 13:30

Lunch

13.30 – 14.45

Post market surveillance and PMCF

Breda Kearney, BSI

14.45 – 15.00

Break

15.00 – 16.00

Q&A session

16.00 – 16.30

Closing session

REGISTRATION

IVDR Technical Documentation Training for Manufacturers
2026-07-02 09:00 - 17:00 | Remotely
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
REGISTRATION

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

2nd Team-NB EU Regulations Discussion Day 2026
2026-11-06 09:00 - 17:00 | Sofitel Brussels Europe, Place Jourdan, 1, Brussels, 1040, Belgium
Registration Fees & Deadlines
Early boocking
250 € 300 € for SMEs and Notified Bodies members
400 € 500 € for organisations
You can register until August 6th
REGISTRATION

Event Summary
This event aims to foster exchanges between stakeholders in the medical device sector.
Three topics of topical matters have been chosen for their relevance to the implementation of the regulatory system.
Team-NB task forces on those matters will present Papers and ongoing work. Members present will answer questions and take note of developments requested by manufacturers.
An information session on EUDAMED will be presented by Commission experts. It will also be followed by discussions.
Finally, Team-NB’s views on the revision outlook will be presented, and a panel of regulators, industry representatives, and notified bodies will answer participants’ questions.
This day will provide an excellent forum for exchanges between regulators, industry representatives, and notified bodies on opportunities for optimizing and modifying the system.

PROGRAM

09.00 – 09.30

Welcome coffee

09.30 – 09.45

Welcome and Introduction

Françoise Schlemmer – Team-NB Director

09.45 – 10.15

BPG on Technical Documentation MDR / IVDR – version 2026

10.15 – 10.45

DIGItalisation of the Conformity Assessment Process

10.45 – 11.00

Break

11.00 – 11.30

EUDAMED – feedback on 1st mandatory use

11.30 – 12.00

Breakthrough Devices Pilot

12:00 – 13:30

Lunch

13.30 – 13.45

Welcome

13.45 – 14.15

Regulatory revisions – state of play

14.15 – 14.45

NBs perspective on the revision

14.45 – 15.30

Panel

15.30 – 15.45

Break

15.45 – 16.15

Artificial Intelligence Act & MDR

16.15 – 16.45

Exchanges and closing

16.45

Drinks
