The truth about the UK vs EU situation

We hear so many things about UK and the timeline and now that EU issued an extension, the question is “Does this change something for UK” So on this episode we’ll review again what are the requirements to go to the UK market.
Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step but for the moment a lot of the products we see are relying on the EU rules.
But UKCA is about to be the rule. I mean we thought this will be the rule but apparently there are new timelines coming.
So let’S discuss that with Claire Dyson
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►Who is Claire Dyson?
Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need.
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Claire Dyson Linkedin page: / claire-dyson-85845b4b
UK transition timelines: www.gov.uk/guidance/regulatin...
UK transition rule: www.gov.uk/government/publica...
UK medical device regulation: www.gov.uk/guidance/regulatin...
UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: assets.publishing.service.gov...
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video:
Claire Dyson Linkedin page: / claire-dyson-85845b4b
UK transition timelines: www.gov.uk/guidance/regulatin...
UK transition rule: www.gov.uk/government/publica...
UK medical device regulation: www.gov.uk/guidance/regulatin...
UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: assets.publishing.service.gov...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
■Authorized Representative and Importer services:easymedicaldevice.com/authori...
■Subscribe to our LinkedIn Newsletter: www.linkedin.com/build-relati...
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@aliceouyang8816]

Thank you for sharing with us this topic! I enjoy listening to the discussion. It will also be helpful on the future to provide a few take home messages at the end to emphasize the major points to remember from this topic.

[@EasyMedicalDevice]

Glad it was helpful! Thanks for your support.