EPISODE · Aug 12, 2022 · 23 MIN
MHRA consultation on UK medical device regulation: Analysis
from The MedTalk Podcast · host The MedTalk Podcast
Ian Bolland is joined by Ashleigh Batchen, Regulatory Affairs Manager from the British In Vitro Diagnostics Association (BIVDA) to discuss the MHRA's published consultation about how medical devices and IVDs will be regulated in the UK post-Brexit. They also touch upon experiences that can be learnt from the implementation of EU MDR and IVDR when transitioning to a new regulation and potential challenges along the way for manufacturers, and when it comes to notified body capacity. You can read the consultation here: https://www.med-technews.com/news/Medtech-Regulatory-News/industry-reacts-to-consultation-on-uk-medical-device-regulat/ This podcast is sponsored by Arena, a PTC Company, for more information visit: https://www.ptc.com/en/products/arena
What this episode covers
Ian Bolland is joined by Ashleigh Batchen, Regulatory Affairs Manager from the British In Vitro Diagnostics Association (BIVDA) to discuss the MHRA's published consultation about how medical devices and IVDs will be regulated in the UK post-Brexit. They also touch upon experiences that can be learnt from the implementation of EU MDR and IVDR when transitioning to a new regulation and potential challenges along the way for manufacturers, and when it comes to notified body capacity. You can read the consultation here: https://www.med-technews.com/news/Medtech-Regulatory-News/industry-reacts-to-consultation-on-uk-medical-device-regulat/ This podcast is sponsored by Arena, a PTC Company, for more information visit: https://www.ptc.com/en/products/arena
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MHRA consultation on UK medical device regulation: Analysis
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