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 will you 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

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.

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

Agenda