The "Introduction to the In-Vitro Diagnostic Regulation (IVDR)" conference has been added to ResearchAndMarkets.com's offering.
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact on the industry.
The In-Vitro Diagnostic Regulation (EU) 2017/746, which came into force in May 2017 with a transition period of five years, is intended to strengthen the current approval system for in-vitro diagnostics and makes substantial changes to the existing IVD Directive (98/79/EC) legislation.
The Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules which, for the first time, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80 per cent of all devices will now require some form of conformity assessment by a Notified Body.
This seminar will clarify the requirements applicable to in-vitro diagnostic devices under the new Regulation, highlight the major changes to responsibility and product data expectations and provide a thorough understanding of the impact on the industry.
Practical workshops over the two days will help consolidate the information provided.
Agenda:
Programme day one
Introduction to IVDs
Historical overview of the current IVD Directive (98/79/EC)
Introduction to IVD Regulation (EU) 2017/746
Notified Bodies
IVD Regulation - key changes
Compiling the technical documentation for an IVD
Labelling requirements and strategies
Day one wrap-up and introduction to day two
Programme day two
ISO 13485:2016
Risk-based classification
Workshop: Product classification
Risk management
Workshop: Risk management
Clinical evidence and common specifications
Vigilance and PMS
Case studies: Reporting/recalls
Key timelines and practical considerations
Discussion: Preparing a roadmap for transition
Speakers:
Nancy Consterdine
Consultant
UL, IVDeology Ltd
Stuart Angell
Director
IVDeology Ltd
For more information about this conference visit https://www.researchandmarkets.com/r/rfrquh