Translate MedTech – Regulatory Affairs for Medical Devices

Are you developing a medical device but not sure what the requirements are to have it CE marked? Are you unsure how new medical device regulations might affect your device?

This training course provides an introduction to the regulatory requirements for placing medical devices on the market. It will help participants to understand the regulatory pathway to CE marking a device. As well as guiding delegates through the Medical Device Directive, this training course will provide information about other relevant guidance, standards and the new Medical Device Regulations.

This training course will cover:

  • What is a Medical Device?
  • The CE Marking process
  • Notified Bodies, National Competent Authorities and Authorized representatives
  • Clinical evidence for medical devices

By the end of the day, you will understand:

  • The current medical device directives and the new Medical Devices Regulation
  • How to classify medical devices
  • How to CE mark a device
  • What information is required for CE marking
  • The role of the Notified Body and the National Competent Authority
  • What clinical evidence is required to CE mark a product and the processes involved

The training course will be run by Janette Benaddi, Medipex Associate.

Open to staff and postgraduate research students at Translate partner universities only (Bradford, Huddersfield, Leeds, Leeds Beckett, Sheffield Hallam and York).

Spaces are limited and registration is essential. Book now to avoid disappointment.

Medipex is the regional NHS Innovation Hub for the Yorkshire & Humber region helping NHS staff commercialise their ideas and innovations.

Janette Benaddi has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She is the former owner of Medvance Clinical Research Ltd. and former Director of Clinical & Consulting Europe for NAMSA- a company which provides clinical research and regulatory consulting services to the medical device and healthcare industries worldwide.

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