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The Basics of IVDR Clinical Studies

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Date/Time

Date(s) - May 26, 2022
10:00 AM - 11:00 AM

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The requirements defined in ISO 20916:2019 and the EU’s In Vitro Diagnostic Regulation (IVDR) 2017/746 (effective May 26, 2022) have introduced several challenges for manufacturers to navigate in order to keep their devices on the market. While compliance to IVDR has been extended based on the risk of the device, many IVDs still require substantial clinical performance studies to be completed. Failure to execute these studies could lead to costly rework for the manufacturer and potentially relabeling or excess inventory.

Join NAMSA for this webinar as we walk through the key differences between EU’s In Vitro Diagnostic Directive (IVDD) and IVDR and the clinical study requirements outlined within these regulations. We will also examine ISO 20916:2019 as the Good Clinical Practice (GCP) guidance for IVD clinical performance.

Attendees of this webinar can expect to gain a better understanding of:

  • Key regulations and applicability
  • Intended use/indications for use/clinical performance
  • IVDR options for clinical performance data, new requirements
  • ISO 20916 as the guide to conducting clinical performance studies for IVD products
  • IVD performance evaluation (high-level requirements)

Time will be allotted for Q&A.

 

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Speaker

Alex Laan

Principal Regulatory Consultant - IVD

Alex Laan has been in the IVD and Medical Device industry for a total of 20 years, with 12 years working for a respectable EU Notified Body. Until recently, Alex held the position of Principal Certification Manager at DEKRA Certification BV, Notified Body for IVDs and Medical Devices located in Arnhem, The Netherlands. After starting at KEMA Quality in 2006, Alex qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVDs and Medical Devices, including drug-device combinations. In these roles, Alex managed projects with large multinationals (a.o. Boston Scientific, Philips), as well as small start-up companies. Alex has been an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as direct contact for EU competent authorities and EMA on implementation of the EU IVDR (2017/746) and EU MDR (2017/745).

Alex has an education as laboratory engineer (BS / Dipl.-Ing) in Bioprocess technology and Biochemistry; University of Teesside, UK. Previously, Alex worked as a product specialist in immune-hematological products and plasma products at Sanquin Blood Transfusion Services, Amsterdam, after which he started his career working as a QA and RA manager for IVD Medical devices at Meddens Diagnostics / IBL Hamburg. At the latter company, Alex developed a QMS system from scratch that enabled the company to register a whole range of assays in the EU (Annex II List B) and US FDA. In addition, Alex followed a post-graduate study in technical management at the Twente University, The Netherlands.