Live Webinar | IVDR Transition for Class B IVDs: What a Notified Body Looks For, and Best Practices for Technical Files

Date: 10 September, 2026

Time: 16:00 - 17:00 CET | 10:00 - 11:00 am EDT

Location: Virtual

Introduction

Class B IVD devices are moderate risk devices such as clinical chemistry tests for metabolic markers, enzymes and hormones and tests for low-risk infectious diseases. Class B IVDs make up about 49% of the total EU IVD market and manufacturers must take the first steps for IVDR transition by 26 May 2027. While class B IVDs pose a lower risk, the general framework of the IVDR and documentation requirements are still applicable.

Class B manufacturers need to ensure they generate the right amount of clinical evidence for their specific device – sufficient to satisfy the Notified Body expectations but not overburdening the teams responsible for technical file generation. Clinical evidence for class B IVDs may include existing data from literature and studies conducted before the applicability of the IVDR. It may be supplemented by post-market performance data collection.

In this live 45-minute session, Heike Möhlig-Zuttermeister (BSI) and Kristiane Schmidt (Qserve) bring together both sides of the conformity assessment process. Kristiane will explain how clinical evidence should look like for Class B devices, and share best practices for generation of technical documentation. Heike will share insights on BSI's processes for class B conformity review and device certification, including review timelines, common deficiencies and what manufacturers can do to ensure a smooth transition.

The session includes a live Q&A. You can submit your questions in advance through the registration form, by emailing marketing@qservegroup.com, or live during the webinar via chat. 

Learning Objectives: 

By the end of this webinar, you will be able to:

• Identify what level of clinical evidence is genuinely required for Class B devices versus higher-risk classes, and identify common documentation gaps before they become review findings
• Describe how the review process works at BSI, including the stages involved and the factors that most commonly lead to delays and extension of review timelines
• Develop a practical step-by-step plan for your own Class B device transition, aligning existing clinical evidence and effort for generation of technical documentation ahead of the submission

Who should attend? 

• IVD Manufacturers
• Regulatory Affairs Specialists
• R&D professionals involved in generation of clinical evidence
• Professionals responsible for compiling Technical Documentation

It's particularly valuable if you manufacture Class B devices and are preparing for the transition to conformity assessment

Agenda

• Welcome & Introduction
• IVD conformity assessment process and review timelines: what BSI checks for (Heike)
• Common issues during IVD conformity assessments and how to avoid them (Heike)
• Clinical evidence requirements for Class B devices (Kristiane)
• Bringing it together: a practical transition plan (Kristiane)
• Live Q&A . 

Don't underestimate the time and effort for Class B transition

Start preparations for your submission now to be ahead of the massive wave of submissions and bottlenecks expected at the end of the transition timelines.

Spots for this live session are limited, and the Q&A is your chance to ask BSI directly about your transition timelines and expectations. Register now to secure your place and submit your questions in advance.

Can't make it live? Register anyway. We'll send the recording to all registrants.