Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Big But 1

On 27th April 2023, the MHRA officially accepted EU extension for MDD and AIMDD certificates as valid for placing CE-marked devices on the Great Britain market as follows: • Class III and IIb implantable non-WET devices 31st December 2027 • Class IIb WET, Class IIa, Class I devices until 30th June 2028 In addition, the MHRA officially extended the standstill period for compliance with UKCA to 1st July 2025 for all Medical Devices and In Vitro Diagnostic Medical Devices on the Great Britain market.

The Organisation for Professionals in Regulatory Affairs

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• In August 2023 UK manufacturers of 12 categories of products persuaded the government to accept CE marking indefinitely • This does not include Medical devices or IVD yet…. So…. Are you sitting comfortably?…. Can you guess what’s going to happen next?.... Big But 2

The Organisation for Professionals in Regulatory Affairs

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