Panel discussion: MedTech regulatory challenges

The Medicines and Healthcare products Regulatory Agency (MHRA) has postponed the date for new UK medical device regulations by a year. Meanwhile, changes to the EU’s European Medicines Agency (EMA) medical and in vitro device regulations are also changing. What does this mean for Enterprise Hub members pursuing regulatory certification? What can we expect in 2024, when new MHRA regulations are slated to take effect?

Moderated by Hub Member and medical device regulations expert Alan Finnerty (Javelo Health), our panel will include experts from ABHI and BSI as well as Hub Members James Roberts (mOm Incubators) and Lucy Jung (Charco Neurotech). The panellists will discuss past experiences, near-term expectations, and future predictions.

Having successfully navigated the CE mark certification process, James and Lucy will share practical tips and best practices that will be valuable in developing effective approaches for gaining market access in the UK and EU, ensuring successful product launches. The panellists will share insights into the intricacies of compliance, market access, and strategic considerations that are crucial for success.

Whether you're a seasoned entrepreneur or navigating your first venture, this panel discussion promises to be an invaluable resource, providing a better understanding of how to integrate regulatory considerations into your overall business strategy for sustainable growth and provide an opportunity to explore what the future might hold.

An opportunity for networking with other Hub Members and Academy partners will take place after the panel discussion and light refreshments will be served.

Venue and accessibility

It is very important to the Royal Academy of Engineering that our events are accessible to all. If you have any accessibility requirements, please contact the Events team more than one week in advance of this event so that necessary arrangements can be made. Contact details: [email protected].  

Further information about accessibility at Prince Philip House can be found at: https://raeng.org.uk/about-us/accessibility.  

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