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Introduction to the In-Vitro Diagnostic Regulation (IVDR)
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 to industry.
Course Overview
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
Programme day one
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
Day one wrap-up and introduction to day two
Programme day two
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
- Transition period
- Practical tips to prepare for IVD Regulation
Discussion: Preparing a roadmap for transition
Presenters
Nancy Consterdine
Nancy Consterdine 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
Stuart Angell 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.
Book now
| 3-4 Nov 2020 | |||
| 3-4 Nov 2020 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
| 11-12 May 2021 | |||
| 11-12 May 2021 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
| 2-3 Nov 2021 | |||
| 2-3 Nov 2021 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
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- Renishaw plc
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- Team Consulting Ltd
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“An enjoyable and insightful course. Good discussions and real-life examples and the exercises were worthwhile and interesting.”
Tracey Jacob, Project Manager, Team Consulting, Nov 19
“Excellent course which give a deep insight into the IVDR regulation without overloading with too much detail.”
Jason Reece, CTO, Genomtec, Nov 19
“This course met all my expectations, money well spent!”
Hilde Sofie Larsen Skaug, Regulatory Affairs Specialist, Gentian AS, Nov 18
“The course was at the perfect level for an IVD industry professional who needed the basics of the new IDV Regulation as well as detailed information on the major areas of change. The speakers were extremely knowledgeable and were able to clearly and concisely answer our questions and guide the discussions until we understood the topic. Their vast experience in our industry gave me confidence that the information and guidance they provided was accurate and reliable. I hope to be able to bring them to one of our Siemens facilities in the US for my other colleagues.”
Kathy Roberts, Quality Engineer / PMO, Siemens Healthineers - Laboratory Diagnostics, Nov 18
“Very knowledgeable people, focusing on the needs of the trainees.”
Marijke De Roeve, Q&C Director, FUJIREBIO EUROPE, Nov 18