High Level Overview EU IVDR 2017/746 and Article 5 Impact on EU LDT practice Dr. Maurizio Suppo Principal Consultant & VP of QARAD As of May 26th, 2022, EU IVD-Regulation 2017/746 will see its first full applicability. This will significantly raise the regulatory barrier for the distribution of IVD devices in the European market. The IVDR also has a very significant impact on the use of laboratory in-house developed assay also known as LDT’s. An impact which gradually decrease the LDT practice over the course of the next years. This presentation attempts to provide clarity on these requirements and their impact to laboratories. Learning Objectives Learn about the EU IVDR 2017/746 regulation Understand the IVDR impact on the use of laboratory in-house developed assay (also known as LDT’s). About the presenter Dr. Maurizio Suppo , Principal Consultant & VP of QARAD Dr. Maurizio Suppo, Principal Consultant & VP of QARAD, a Belgium-based consulting company specialized in EU legislations for medical devices and in-vitro diagnostic products. Areas of expertise include, EU and non-EU regulations, Quality Systems – ISO 9001 / ISO 13485, Quality System audits (9001/13485), Authorized Representative services, performance evaluation studies, multi-language labelling, international standards and MDSAP. Dr. Suppo is a trained auditor in ISO 13485: 2016 and MDSAP. Up to date Dr. Suppo has performed a total of 13 MDSAP mock audits of both IVD and Medical Device manufacturers. Each MDSAP mock audit lasted for full five days for a total of 520 hours of MDSAP auditing experience. In November 2018 Dr. Suppo has been nominated one of the 5 finalists for the TOPRA (*) 2018 Awards for Regulatory Excellence in the category of Contribution which recognizes regulatory professionals who have made a significant and consistent contribution to a team, project, regulatory science, or the profession. *The Organization of Professionals in Regulatory Affairs (www.topra.org). Dr. Suppo is a member of European Commission IVD Technical group defining EU regulatory issue for IVDs & the European Association of Authorized Representatives (EAAR) Leica Biosystems Knowledge Pathway content is subject to the Leica Biosystems website terms of use, available at: Legal Notice. The content, including webinars, training presentations and related materials is intended to provide general information regarding particular subjects of interest to health care professionals and is not intended to be, and should not be construed as, medical, regulatory or legal advice. The views and opinions expressed in any third-party content reflect the personal views and opinions of the speaker(s)/author(s) and do not necessarily represent or reflect the views or opinions of Leica Biosystems, its employees or agents. Any links contained in the content which provides access to third party resources or content is provided for convenience only. For the use of any product, the applicable product documentation, including information guides, inserts and operation manuals should be consulted. Copyright © 2024 Leica Biosystems division of Leica Microsystems, Inc. and its Leica Biosystems affiliates. All rights reserved. LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH. If you have viewed this educational webinar, training or tutorial on Knowledge Pathway and would like to apply for continuing education credits with your certifying organization, please download the form to assist you in adding self-reported educational credits to your transcript. Apply for self-reported educational credits Get Knowledge Pathway updates delivered directly to your inbox. Subscreva hoje! We are looking for more great writers to feature here. Send us a submission and we’ll be in touch! Send your writing! SHARE Facebook Twitter LinkedIn Email
