Patient Guard

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December 2023 News Letter

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As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year.  What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective? 

The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification – May 2024

We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.

EU MDCG Guidance Updates in December 2023

image of a card with the ISO logo on it in blue - this is used to represent content displayed by patient guard relating to medical device and IVD regulatory affairs and quality assurance as well as standards

Medical Device Standards Updated in December 2023

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