This course will be delivered by the trainers virtually as two 3-hour sessions which will take place on Monday 29 and Tuesday 30 November (9:30am – 12:30pm).
This course, delivered as two 3-hour sessions across two separate days, is an introduction to medical devices and the regulatory requirements for placing medical devices on the market and CE marking of devices. It will help you to understand the regulatory path to CE marking a device, deciphering all the regulatory jargon and understanding the new Medical Device Regulations in Europe as well as the UK legislation.
By the end of the course, you should be well set up to understand the requirements and responsibilities and plan your organisation’s regulatory and clinical strategy. As well as guiding you through the regulations, it brings you up to scratch with all the other relevant guidance, standards and the new Medical Device Regulations both in Europe and the UK.
Open to academics, researchers, clinicians and industry representatives, by attending the course you will:
• Learn about the NEW medical devices regulation implemented in Europe in May 2021 and the situation in the UK
• Learn how to CE mark a device or to UKCA mark your device
• Learn how to classify medical devices
• Determine the information required for CE marking or UKCA mark
• Understand the role of the Notified Body and the National Competent Authority
• Learn about the clinical evidence that is required to CE/UKCA mark a product and the processes involved
• What is a Medical Device?: How you determine if your product is a medical device; what regulations govern the marketing of medical devices; and how devices are classified
• The CE Marking process: How to get a CE mark for your device; what the process is; what regulations, guidance and standards you need to follow; and what documentation you need. Notified Bodies, National Competent Authorities and Authorized representatives – who they are and what do they do.
• Workshop on Classification
• Clinical evidence for medical devices: What evidence you need; when and how you collect it; and what the regulations and guidance applicable to medical device clinical studies are (including clinical evaluation and clinical investigation).
• Brexit and the UK market for medical devices
• Course Quiz – covering Day 1 and Day 2
The training course will be run by Janette Benaddi, Medipex Associate.
Spaces are limited and registration is essential. Please note in order to ensure all participants get the maximum out of the course by registering you are committing to attending the full duration of the course over both days.
This course will be delivered by the trainer remotely via video conferencing software. Information about how to join the conferencing call will be emailed to everyone that has registered.
Free to staff and postgraduate research students at Translate partner universities (Bradford, Huddersfield, Leeds, Leeds Beckett, Sheffield Hallam and York). Places for industry and clinical representatives are available at a cost of £45, please email Kelly Broadbent (K.L.Broadbent@leeds.ac.uk) to secure your ticket.
Medipex is the regional NHS Innovation Hub for the Yorkshire & Humber region helping NHS staff commercialise their ideas and innovations.
About the trainer
Janette Benaddi is a business mentor, international speaker/trainer and expert consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Throughout her career Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She has also received an honorary doctorate in Health Sciences form York St John’s University.