High Level Overview EU IVDR 2017/746 and Article 5 Impact on EU LDT practice
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, 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)
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