Meet the Experts: In Vitro Diagnostic Regulation
What is the event about?
Navigating the path to bring an In Vitro Diagnostic product to market starts by having the right information to comprehend the regulatory journey. Meet the Experts: IVDR will focus on understanding the requirements of the In Vitro Diagnostic Regulation (IVDR) and ISO 13485, maintaining certification and managing post-market obligations. Whether you are an In Vitro Diagnostic (IVD) manufacturer, regulatory affairs professional or IVD startup, this event is your opportunity to gain insights and ask the questions that matter most. At the event, you can expect to:
- Broaden your IVDR knowledge and understanding
- Learn what a successful IVDR submission looks like
- Understand the pathway to CE marking
- Gain knowledge of post-certification requirements
- Connect directly with BSI’s IVDR specialists
What You’ll Gain:
- The latest updates on the IVDR
- Real-world case study and lessons learned from IVDR submissions
- Answers to your questions in a live Ask the Experts Q&A session
- Deep-dive workshops to help you navigate the IVDR
This is not a lecture. It is a practical, participant-led day where you hear from the people who assess submissions against the requirements of the IVDR; and where you get to ask the questions that matter most to you.
Why Attend?
- Stay current on the regulatory landscape: get the latest updates on IVDR transition timelines, Annex VII requirements, Class D devices, breakthrough devices, and what IVR 2.0 means in practice.
- Understand the full regulatory picture: hear how IVDR, ISO 13485 and MDSAP interact and where the requirements overlap, so you can plan your compliance approach with confidence.
- Learn from real-world experience: gain insight into what a robust submission looks like, where manufacturers commonly encounter difficulties, and what BSI's assessment process involves.
- Prepare for post-certification: understand what maintaining certification requires, how to manage changes effectively, and how to work with your post-market surveillance data.
- Ask the experts directly: put your specific questions to BSI's Notified Body specialists in a live panel Q&A.
- Build connections: network with BSI experts and peers from across the IVD industry.
Who Should Attend?
This event is designed for anyone navigating the IVDR regulatory landscape, including:
IVD manufacturers: new, existing, and transferring clients
Start-ups preparing for their first IVDR submission
Regulatory affairs and quality managers
IVD consultants
You can book a 1-to-1 meeting with a representative of our team.
Up to 2 participants per company will be admitted to the event to allow diversified companies to participate and engage.
Event Video
- Insightful Presentations – BSI’s Industry leaders and regulatory experts share insights on navigating MedTech compliance.
- Interactive Sessions – Direct engagement with regulators to clarify expectations and address compliance concerns.
- Network with Industry Peers – Connect with like-minded startups and key stakeholders in the HealthTech ecosystem.
Event Details
Networking Reception
To kick off the event, join us at the networking reception on 23 November, 18:00–20:00 CET. This will provide the perfect opportunity to meet and mingle with speakers and fellow attendees in a relaxed atmosphere. Don't miss the chance to meet and connect with our IVDR experts and commercial team to address your IVDR challenges and key questions.
Book your hotel room with a discount of 10% on the best available rate. Please note, this rate changes daily and is available for the event dates only : https://www.hotelschiphol.com/discount-rate/10-discount/
Use code: EVENT010
Free parking available for event attendees.
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