Introduction to the In-Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 Course: London, UK - November 26-27, 2018 - ResearchAndMarkets.com

September 18, 2018

DUBLIN--(BUSINESS WIRE)--Sep 18, 2018--The “Introduction to the In-Vitro Diagnostic Regulation (IVDR)” conference has been added to ResearchAndMarkets.com’s offering.

The new In-Vitro Diagnostic Device Regulation (EU) 2017/746 came into force in May 2017 with a transition period of 5 years. The IVD Regulation is significantly different from the IVD Directive, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in-vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation.

The IVD Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification which, for the first time, takes patient impact into consideration. This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-declare devices but under the new regulation about 80% of IVDs require some form of conformity assessment by a Notified Body.

By attending this course, you will:

Gain a comprehensive overview of the new IVD regulation Be aware of how the role of the Notified Body will change under the IVD regulation Understand the requirements of the Technical Documentation for an IVD Plan your labelling requirements and strategies Know the key changes to ISO13485 Learn how IVDs are classified Understand the requirements for clinical evidence Know the vigilance and Post Market Surveillance (PMS) requirements for IVDS

Who should attend:

Regulatory affairs personnel Persons responsible for regulatory compliance Quality assurance professionals Those responsible for OEM/Subcontractor control of IVDs Economic operators, importers, distributors


Day One

Introduction to IVDs Historical overview of the current IVD Directive (98/79/EC) Introduction to IVD regulation (EU) 2017/746 Notified Bodies (NB) Key changes to IVD Regulation Compiling the technical documentation for an IVD Labelling requirements and strategies Day one wrap up and introduction to day two Close of day one

Day Two

Welcome and recap on day one ISO13485:2016 Risk-Based classification Workshop - Product classification Risk management Workshop - Risk management Clinical evidence and common specifications Vigilance and Post Market Surveillance (PMS) Case studies: Reporting/recalls Key timelines and practical considerations Discussion: Preparing a roadmap for transition Wrap and close of forum

For more information about this conference visit https://www.researchandmarkets.com/research/z4nmjw/introduction_to?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180918005803/en/

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Related Topics:In Vitro Diagnostics



SOURCE: Research and Markets

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PUB: 09/18/2018 11:40 AM/DISC: 09/18/2018 11:40 AM


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