IVDR European Roadshow 2025 – Unveiling the Future of In Vitro Diagnostics.
Next stop: Courbevoie I France - September 24th 2025
Join TÜV Rheinland’s in-person, one-day seminar designed exclusively for IVD manufacturers. This event delivers essential knowledge, practical tools, and the latest regulatory insights to help you navigate IVDR compliance with confidence.
Learn directly from TÜV Rheinland experts on certification strategies, technical documentation, performance evaluations, and transitional timelines. Connect with peers, exchange experiences, and get answers to your most pressing compliance questions.
This event is tailored for IVD manufacturers aiming to deepen their understanding of IVDR requirements, certification strategies, and current developments in both the EU and French regulatory landscapes.
Key topics to be covered include:
- Effective certification strategies under IVDR
- Preparing technical documentation that passes review
- Conducting performance evaluations & PMPF
- Navigating transitional timelines & international approvals
Location: Courbevoie, France | TUV Rheinland France SAS. 20 ter rue de Bezons CS 60030. 92415 Courbevoie cedex
Date: 24 September 2025
Language: English
Meet our Experts
Daniel Świątko
Regional Business Field Manager Medical.
Responsible for the development of the medical certification and testing business in Europe. An experienced auditor and certification expert in both active and non-active medical devices.
Agnieszka Topolska-Wos
IVD Medical Devices Specialist, Lead Auditor
Auditor and expert in in vitro medical diagnostics devices. Many years of experience in the medical devices industry.
Agenda
Morning
09:00 - 09:20
Welcome by TÜV
09:20 - 10:30
Certification strategy IVDR
10:30 - 10:45
Coffee Break
10:45 - 11:30
Guidance for IVDR Technical Documentation
11:30 - 12:15
Performance evaluation and PMPF
12:15 - 13:00
Lunch Break
13:00 - 14:00
International Approvals and IVDR Article 16.
A practical alternative for distributors, manufacturers, and importers using the OEM–PLM procedure.
14:00 - 14:30
Q&A session
14:30 - 15:00
Coffee Break
Afternoon
15:00 - 15:30
IVD device testing
15:30 - 16:00
Transitional timelines according to 2024/1860
16:00 - 16:15
Q&A session
16:15 - 16:30
Closing and thanking the participants
Choose Your City to Experience an Engaging Day of Insights and Networking!
Our roadshow is making its way to two additional international locations—be one of the first to register !
Copenhagen, Denmark
08.10.2025 | Clarion Hotel
Language: English
Leiden, Netherlands
14.10.2025 | Fletcher Wellness-Hotel
Language: English
Seats are limited — secure your spot early!
Pricing & Seats
Registration Fee: €49
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