IVDR European Roadshow 2025 – Unveiling the Future of In Vitro Diagnostics.
Next stop: Copenhagen, Denmark 08.10.2025
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: Copenhagen, Denmark - 08.10.2025 at Clarion Hotel | Ellehammersvej 20. 2770, Kastrup, Denmark
Date: 8 October 2025
Language: English
Participation Fees: Free of charge
Meet the 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.
Marta Trzpil
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
We invite you to register here for this unique seminar
Given the limited room capacity - we will limit to maximum 2 participants per company.
You will receive confirmation of your participation within a few days after submitting the form.
By registering for our seminar, you agree to receive confirmations, reminders and emails regarding it, including documents, videos and presentations, as well as to be contacted by sales representatives on related topics.
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 !
Seats are limited — secure your spot early!
YOUR PARTICIPATION IS FREE OF CHARGE
Courbevoie, France
24.09.2025 | TUV Rheinland France
Language: English
Leiden, Netherlands
14.10.2025 | Fletcher Wellness-Hotel
Language: English
