Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Brexit

• 1 st January 2021 • UK left the EU with current legislation being translated to UK law • For Devices, this means the UK will continue to follow the Medical Device, IV and AIMD Directives as MDR is not fully implemented • For Medicines, there would be no changes to the legal requirements other than those associated with the national implementation

The Organisation for Professionals in Regulatory Affairs

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Medical Devices

• MHRA is now the agency responsible for medical devices in the UK • UK Notified Bodies will have their designations rolled over for certifying UK products • UK will adopt it’s own UKCA marking system, as it will no longer be part of the EU CE marking system

The Organisation for Professionals in Regulatory Affairs

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