Introduction to the In-Vitro Diagnostic Regulation (IVDR) Online Training Course (November 3-4, 2022)
Dublin, Oct. 04, 2022 (GLOBE NEWSWIRE) -- The "Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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
Key Topics Covered:
Introduction to IVDs
Definition of an IVD
Why are IVDs regulated separately?
Investigating standards and their use
Exploring CE marking
Historical overview of the current IVD Directive (98/79/EC)
Examining the structure and content of the IVD Directive
Introduction to IVD Regulation (EU) 2017/746
How did we come from the Directive to the Regulation?
Main drivers for change
Scale of change
Structure and Annex
Notified Bodies
How has the role of the Notified Bodies changed under the IVD Regulation?
Conformity assessment
IVD Regulation - key changes
Persons responsible for regulatory compliance
Economic operators, importers, distributors
UDI
Software
Intended use/intended purpose
(including an interactive workshop)
Performance evaluation
Clinical evidence
Compiling the technical documentation for an IVD
Structure and content of STED
Technical file vs design dossier
Labelling requirements and strategies
Understanding electronic instructions for use (e-IFUs)
Use of language and symbols
Translation requirements
Traceability and EUDAMED
UDIs
ISO 13485:2016
Introduction to ISO 13485
Key changes from 2012 to 2016
Where does it fit with IVDD & IVDR?
Risk-based classification
How are IVDs classified?
Workshop: Product classification
Discussion on the classification of example IVDs
Risk management
Regulatory requirements
ISO14971
Usability
Workshop: Risk management
Clinical evidence and common specifications
Scientific validity vs performance evaluation
Vigilance and PMS
Regulatory requirements
Incident reporting/FSCA management
Case studies: Reporting/recalls
PMS
Key timelines and practical considerations
Discussion: Preparing a roadmap for transition
Speakers:
Nancy Consterdine
Consultant
UL, IVDeology Ltd
Nancy Consterdine. This MDTI expert is a joint director in her own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices, focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
She has over 30 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex II list products. Also identifying regulatory strategies around global submissions (EU, FDA, Health Canada, TGA, Russia, Latin America and China). She has a special interest in labelling and UDI requirements.
Stuart Angell
Director
IVDeology Ltd
Stuart Angell, This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
For more information about this conference visit https://www.researchandmarkets.com/r/wvzn4c
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