IMed’s Tim Bubb presents at RAPS Euro Convergence 2022 in Amsterdam

by | May 11, 2022 | Clinical Writing, UKRP

MHRA Guidance

Our Head of Medical Devices, Tim Bubb, has been selected to present his views on the changing UK Medical device and IVD regulatory landscape at the RAPS Conference for Regulatory professionals alongside the UK regulator MHRA and UK approved body BSI.

The session entitled ‘Regulatory Requirements for Medical Devices within the UK’  is taking place on Wednesday 11th May 2022 at 14:45 on the ground floor of the Pearl 3 conference venue and the content is summarised in the conference schedule as follows;

Medical device regulations were one of the first regulations to diverge between the UK and the EU; creating challenges for IVD and medical device manufacturers across the world. This session will help you address some of these challenges and provide some clarity on the current and future regulatory requirements.


The team will cover the current requirements and the best practices to place a device on the UK market. It will describe the requirements for device registration, UKCA marking, and UK approval bodies.


In addition, the speakers will outline the potential future regulatory landscape within the UK, and what a device manufacturer may expect post 2023. Will we see further divergence between the UK and the EUs regulatory requirements, or will we see a closer alignment? This session will cover these hot topics and provide insight from Industry, UK Approval Bodies, and the UK regulator.

Learning Objectives:

  • Describe the current challenges and best practices to place your product on the UK market
  • Outline the proposed/future post-Brexit regulatory requirements
  • Discuss a UK approval bodies perspective on the current and future regulatory requirements

With Tim’s expertise in navigating Global regulatory differences over multiple device types, including all classifications up to class III, implantable and active devices AND software and AI – qualify him supremely to offer his views on these pivotal issues.

Please attend the session if you are at RAPS Euro Convergence 2022 today!

 

Timothy Bubb

Timothy Bubb

Head of Medical Devices

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