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.
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.
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
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
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.
| 19-20 Nov 2019 | |||
| 19-20 Nov 2019 | Cavendish Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now Limited places |
| 5-6 May 2020 | |||
| 5-6 May 2020 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol 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 |
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“Very knowledgeable people, focusing on the needs of the trainees.”
Marijke De Roeve, Q&C Director, FUJIREBIO EUROPE
“This course met all my expectations, money well spent!”
Hilde Sofie Larsen Skaug, Regulatory Affairs Specialist, Gentian AS
“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