An overview of the key aspects of IVDR compliance

What is the webinar about?

The webinar presents an overview of the key aspects of IVDR compliance, focusing on the common pitfalls related to the technical documentation and Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR). The webinar is tailored to SMEs in the IVDR space that are starting their IVDR implementation journey.

Who should attend?

All SMEs who intend to apply for CE marking under the In Vitro Diagnostic Regulation. This webinar will 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 extended webinar to hear subject matter experts, Alex Laan, BSI’s Head of IVD Notified Body and Liz Harrison, Global Head of IVD, talk about the key IVDR changes and lessons learnt so far, as well as tips on preparing a comprehensive Technical Documentation and the Performance Evaluation requirements under the IVDR. You will also gain a better understanding of the status related to high-risk CDx & Class D devices.

The webinar will include:

• History Lesson: Key IVDR changes… why and when?
• Telling a Story: Creating effective technical documentation
• Clinical Evidence: Understanding the requirements
• High Risk update: Current status of CDx & Class D devices
• Q&A sessions with panel

Alex Laan recently joined BSI as the Head of IVD Notified Body. In this position, Alex will be focusing on further strengthening the regulatory foundations within the IVD team and 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.

Dr Elizabeth Harrison is BSI's Global Head of In Vitro Diagnostics. She is responsible for operational delivery of technical documentation review and certificate decisions for IVDD, IVDR and UKCA.

Before joining BSI in 2014, she held senior and principle scientist roles in design and development of NAT diagnostic platforms for near-patient testing of sepsis, respiratory infections, genetic disease, cancer and companion diagnostics. She also spent time as a post-doctoral scientist in the School of Translational Medicine at the University of Manchester investigating rapid diagnostics for sepsis and respiratory disease.

Liz holds a BSc (Hons) in Biochemistry and a PhD in molecular diagnostics.

Todd is the VP, IVD Sales Solutions in the Americas for BSI Regulatory Services (Medical Devices). He has a broad range of responsibilities focused on helping IVD medical device manufacturers achieve quality systems registration and product certification. Mr. Moorman creates learning and development opportunities for clients and colleagues to gain knowledge of global regulatory requirements, medical technologies and the healthcare marketplace.

Prior to his 16 years with BSI, Todd spent eleven years at Thomson Scientific, a division of Thomson Reuters, where he led a team of product specialists, sales support, and customer trainers within the pharmaceutical/chemical sector. Todd earned his BA from the University of Kansas.