Introduction to the EU Medical Device Regulation (EU) 2017/745 – Interactive workshop

Overview

Are you developing a device or digital solution for the health sector and are contemplating deployment within the EU? Are you unsure if you need to adhere to the EU Medical Device Regulations (MDR) or how to risk classify your medical device? Are you aware of the requirements a medical device needs to conform to in order to achieve MDR certification?

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

Who should attend?

People with an interest in the development of medical devices / digital health solutions, 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 / digital health solution is classified as a medical device under the EU MDR.

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

Find the requirements that medical devices need to conform too.

Gain 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