Medical device regulations – product and risk classification


Medical device regulations – product and risk classification

Date: March 23, 2022 @ 10:00 AM

Location: Online

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Are you developing a device for the health sector? Unsure if you need to adhere to the Medical Device Regulations? Or what the risk classification of your medical device is?

A free online course offered by the IKC and delivered by the creators of RegMetrics aims to demystify medical device regulations for up-and-coming innovators.

The purpose of this workshop is to discuss the first key aspects of the medical device regulations: how to determine when a product is a medical device and what the risk classification of the device is.

This course is free to attend for anyone working in the area of medical devices/in vitro diagnostic medical devices or digital health solutions, including: academic researchers, clinicians, science students, innovators, start-ups, SMEs, research councils, research services and tech transfer support.

Delegates will be shown how to use the RegMetrics tool, a free online resource to make the navigation of medical device regulation easier and more accessible. Developed by the Natural Interaction Lab at the University of Oxford, this tool is designed to support innovators and investors in answering the initial crucial questions that will form a regulatory strategy. It supports both EU medical device regulations (MDR) and the in vitro diagnostic medical device regulations (IVDR), and has been reviewed by regulatory authority.

By the end of the session, delegates will be able to:

  • Identify if a device/digital health solution is a medical device
  • Classify a medical device according to the Medical Device Regulation (EU) risk levels
  • Experience using the online regulatory tool: RegMetrics

The course will be run online via Zoom, log in details will be sent to registered delegates one week in advance.


About the trainer

Rita Hendricusdottir is the CEO of RegMetrics, a spin-out company from University of Oxford. RegMetrics develop digital solutions to support innovators navigate the regulations. One of the solutions is the RegMetrics platform, a digital tool to make it quicker and easier to understand how medical device regulations (both MDR and IVDR) apply to your product in order to obtain a CE mark certificate.

Rita holds a PhD from the Medical Research Centre (MRC) at King’s College London. Throughout her career, she has been part of international multidisciplinary networks and has led large international initiatives in bridging the gaps between different scientific disciplines. Rita played a significant role in setting up and leading the training workstream within ELIXIR, European infrastructure for big data within biological research. She has also experience in working with big pharmaceutical companies. She was involved in the REFORM research on ‘Data-driven healthcare: regulation & regulators’ and closely works with key stakeholders in the regulatory area, such as the MHRA and NHSx. She has given workshops on MDR classification for IEEE and EIT Health and has published on the topic of digital solutions for regulatory navigation.

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