IVDR Technical Documentation Training for Manufacturers
2026-07-02 09:00 - 17:00 (Europe/Paris) | 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
