DUBLIN–(BUSINESS WIRE)–The lecture “Introduction to In Vitro Diagnostics Regulation (IVDR) Training Course” has been added to from ResearchAndMarkets.com offer.
The In Vitro Diagnostics Regulation (EU) 2017/746, which entered into force in May 2017 with a five-year transition period, aims to strengthen the current in vitro diagnostics approval system and makes substantial changes to the existing IVD directive. (98/79/EC).
The regulations introduce a new risk rule classification system based on Global Harmonization Task Force (GHTF) rules that, for the first time, takes into account the impact on patients. This will have a significant impact on all IVD manufacturers as approximately 80% of all devices will now require some form of Notified Body conformity assessment.
This seminar will clarify the requirements for in vitro diagnostic devices under the new regulation, highlight major changes in liability and product data expectations, and provide an in-depth understanding of the impact on the industry.
Practical workshops over the two days will consolidate the information provided.
Who should attend:
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Regulatory Affairs Staff
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Regulatory Compliance Officers
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Quality Assurance Professionals
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IVD OEM/Subcontractor Control Managers
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Economic operators, importers, distributors
Main topics covered:
Introduction to IVDs
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Definition of a DIV
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Why are IVDs regulated separately?
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Study standards and their use
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Explore CE Marking
Historical overview of the current IVD Directive (98/79/EC)
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Review of the structure and content of the IVD Directive
Introduction to IVD Regulation (EU) 2017/746
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How did we go from Directive to Regulation?
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Main Drivers of Change
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scale of change
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Structure and appendix
Notified Bodies
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How has the role of Notified Bodies changed under the IVD Regulation?
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Conformity assessment
IVD Regulation – key changes
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Regulatory Compliance Officers
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Economic operators, importers, distributors
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IDU
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Software
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Intended use/intended use
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(including an interactive workshop)
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Evaluation of performances
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Clinical evidence
Compilation of technical documentation for a DIV
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Structure and content of STED
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Technical file vs design file
Labeling requirements and strategies
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Understanding the Electronic Instructions for Use (e-IFU)
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Use of language and symbols
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Translation requirements
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Traceability and EUDAMED
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IDU
ISO 13485:2016
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Introduction to ISO 13485
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Main changes from 2012 to 2016
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Where does this fit in with the IVDD and IVDR?
Classification based on risk
Workshop: Classification of products
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Discussion on the classification of examples of IVDs
Risk management
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Regulatory requirements
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ISO14971
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Usability
Workshop: Risk management
Clinical evidence and common specifications
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Scientific validity vs performance evaluation
Vigilance and PMS
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Regulatory requirements
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Incident Report/FSCA Management
Case studies: reports/reminders
Key timelines and practical considerations
Discussion: Preparing a roadmap for the transition
Speakers:
Nancy Consterdine
Consultant
UL, IVDeology Ltd
Nancy Consterdine. This MDTI expert is co-director of her own consulting firm specializing in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices, focusing on the transition to new IVD/Medical Device regulations, MDSAP and ISO13485:2016.
She has over 30 years of experience in the IVD industry and in her previous roles she was responsible for the design, review and maintenance of regulatory frameworks for self-declared products and the list of Annex II. Also identify regulatory strategies around global submissions (EU, FDA, Health Canada, TGA, Russia, Latin America and China). She is particularly interested in labeling and UDI requirements.
Stuart Angel
Director
IVDeology Ltd
Stuart Angel. This MDTI expert is co-director of his own consulting firm specializing in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to new IVD/Medical Devices, MDSAP and ISO13485:2016.
He has over 15 years of experience in the IVD industry and in his previous roles he was responsible for the design, review and maintenance of regulatory frameworks for self-declared products and the Schedule II list. , including technical documentation for European 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 on this conference, visit https://www.researchandmarkets.com/r/van985
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