About the event

Navigating the path to bring an In Vitro Diagnostic 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 IVD manufacturer, a regulatory affairs professional or an In Vitro Diagnostic (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 will gain

  • The latest updates on the IVDR
  • Real-world case study and lessons learned from IVDR submissions
  • A live Ask the Experts Q&A session
  • Deep-dive workshops to help you navigate the IVDR

Agenda

Time Subject
8:30 AM - 8:45 AM Welcome and Intro
8:45 AM - 10:15 AM Regulatory Updates (EU/UK)
10:15 AM - 10:30 AM Coffee Break
10:30 AM - 11:30 AM QMS Requirements
11:30 AM - 12:00 PM Next Generation Companion Diagnostic Devices
12:00 PM - 1:00 PM Lunch
1:00 PM - 2:00 PM New Applications
2:00 PM - 3:00 PM On-going Certification
3:00 PM - 3:15 PM Coffee Break
3:15 PM - 3:50 PM Panel Discussion and Q&A
3:50 PM - 4:00 PM Wrap up

 

 

 

 

 

 

 

 

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 IVDR 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 best practice guidance 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

Save your seat

To find out more about our comprehensive and proven regulatory services, visit our dedicated In Vitro Diagnostic Regulation (IVDR) webpage.

Email: us.medicaldevices@bsigroup.com

Phone: +1 888 429 6178

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