Introduction to the EU Diagnostic Medical Devices Regulation (EU) 2017/746 – Online interactive workshop

Overview

Are you developing an in vitro diagnostic device (IVD) for the health sector and are contemplating deployment within the EU? Are you unsure if you need to adhere to the EU Regulation on in vitro Diagnostic Medical Devices (IVDR) or how to risk classify your IVD? Are you aware of the requirements an IVD needs to conform to in order to achieve IVDR certification?

The objective of this HRC workshop is to learn the first key aspects of the EU IVDR: to determine when a product is a IVD, what the risk classification of the IVD is and what the next steps are.

Who should attend?

People with an interest in the development of in vitro diagnostics, including: academic researchers, clinicians, students, innovators, startups, SMEs, research councils, research services and tech transfer organisations.

What will I learn?

By the end of the workshop attendees will be able to:

Identify if a device is classified as an in vitro diagnostic medical device under the EU MDR.

Classify a medical device according to the EU IVDR risk classification system.

Find the requirements that in vitro diagnostic medical devices need to conform too.

Practical experience of using the regulatory tool: RegMetrics.

Course director – Professor Jeroen Bergmann

Jeroen is theme lead of the HRC’s Need-led Device Development and Regulatory theme, providing biomedical engineering and regulatory support across the HRC and to HRC stakeholders. Jeroen studied at London, Amsterdam, and Oxford, and holds or has held (visiting) teaching and/or research positions at some of the world’s top institutions including King’s College London, Imperial College London, University of Oxford, MIT, Harvard, and is now Head of the Department of Technology and Innovation at the University of Southern Denmark. He is co-founder of the RegTech platform RegMetrics.

Course lead – Dr Rita Hendricusdottir

Rita is the CEO of RegMetrics and holds a PhD in Neuroscience at King’s College London. She is passionate about making sure that patients have access to the latest technologies that can improve their quality of life. In order for MedTech companies to bring new medical devices to the market, they have to adhere to medical device regulatory requirements. The challenge is to bridge the knowledge gap between engineering and law. Rita has always been fascinated with how to best connect disciplines in order to generate the strongest outcomes. Her previous work involved bridging the gap between biology and bioinformatics to foster efficient collaboration (ELIXIR) or to ensure that Pharma departments had consistent understanding of a subject area (OxfordPharmaGenesis).

About RegMetrics

RegMetrics is a regulatory compliance software that supports the user to navigate regulatory requirements step by step. The software is easy to use, saves time, and no prior regulatory knowledge is required. RegMetrics provides an objective and trustworthy approach with all its content referencing regulatory documentation, whilst using data driven technologies to cater for all types of medical devices from software to hardware, as well as in-vitro diagnostics