Where do we stand 18 months after DoA?

Date: 28 November 2023

Sprache: Englisch

With the IVDR having entered into force on 26 May 2022, there are still many questions and challenges for IVD manufacturers facing the difficult task of implementing the regulation. Join this insightful webinar to hear about the latest IVD regulatory updates.

What is the webinar about?

This webinar will provide attendees with the latest BSI knowledge and best practise with regards to IVDR Regulatory Updates. This will include:

• A short recap on where the IVDR is (latest MDCG guidance and developments in Brussels)
• Description of the challenges for Class D IVD’s and the status on EU Reference Labs
• Envision the potential ramifications for manufacturers of these updates.

Who should attend?

This webinar will be of particular interest to manufacturers of IVD devices. It will also offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have experience of working with a notified body.

What will participants gain?

Join this insightful webinar to hear subject matter expert, Alex Laan, Global Head of IVD at BSI share his knowledge, hints, and tips on latest IVD regulatory updates. You will also gain a better understanding of the status related to IVDR and envision the potential ramifications for manufacturers of these updates.

Alex Laan joined BSI as the Head of IVD Notified Body in November 2022. In this position, Alex focuses on further strengthening the regulatory foundations within the IVD team and looking to make BSI future-proof for the years to come in the challenging regulatory environment in the EU for IVD’s.

Alex is originally a biochemical engineer and worked on the design and development of ELISA based assays in virology and immunohematology tests. He has worked a technical specialist in reagents and tests at Sanquin blood bank located in Amsterdam.

He holds degrees in Biomedical Chemistry, Biotechnology and Business Administration.