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.

The post The truth about the UK vs EU situation appeared first on Medical Device made Easy Podcast. hamza benafqir

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 

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. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/ 

UK transition timelines: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

UK transition rule: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations 

UK medical device regulation: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_theUnited_Kingdom.pdf 

Social Media to follow:

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

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The post The truth about the UK vs EU situation appeared first on Medical Device made Easy Podcast. hamza benafqir