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.
Brochure will be available shortly.
26-27 Nov 2018
& 21-22 May 2019
The new In-Vitro Diagnostic Device Regulation (EU) 2017/746 came into force in May 2017 with a transition period of 5 years. The IVD Regulation is significantly different from the IVD Directive, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in-vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation.
The IVD Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification which, for the first time, takes patient impact into consideration. This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-declare devices but under the new regulation about 80% of IVDs require some form of conformity assessment by a Notified Body.
Practical workshops over the two days will help consolidate the information provided.
By attending this course, you will:
9.30 Welcome and introduction
9.45 Introduction to IVDs
10.30 Historical overview of the current IVD Directive (98/79/EC)
11.15 Introduction to IVD regulation (EU) 2017/746
12.00 Notified Bodies (NB)
13.30 Key changes to IVD Regulation
15.15 Compiling the technical documentation for an IVD
15.45 Labelling requirements and strategies
16.45 Day one wrap up and introduction to day two
17.00 Close of day one
9.00 Welcome and recap on day one
9.45 Risk-Based classification
10.15 Workshop – Product classification
11.00 Risk management
11.45 Workshop – Risk management
13.30 Clinical evidence and common specifications
14.15 Vigilance and Post Market Surveillance (PMS)
15.00 Case studies: Reporting/recalls
15.45 Key timelines and practical considerations
16.30 Discussion: Preparing a roadmap for transition
16.45 Wrap up and close of forum
Nancy Consterdine (26-27 Nov 2018)
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 (26-27 Nov 2018)
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.