The UK is currently revising their regulatory framework for devices and today (7 March 2023) published an update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. The full update can be found here: Advisory Group Reform Proposals - GOV.UK (www.gov.uk).
The challenge the UK face is to create a process to provide a pathway for devices on the EU or US markets continued UK market access without duplicating effort whilst also providing a pathway for new innovative devices to gain market access and to enable UK based manufacturers to place devices on the UK market through domestic assurance.
The announcement today indicates a direction of travel and does not provide details. It proposes a tough and ambitious target to assess the proposals on the table by the end of April.
The three key points are:
- To help create a system wide UK integrated pathway for HealthTech, MHRA to become a more responsive regulator with supportive innovation pathways;
- Ensure the supply of safe medical devices to UK patients is maintained through expanded recognition (e.g. to US approvals) and removing burden where possible;
- Ensure the future system is enabled, and avoids current challenges, through the development of a UK regulatory skill programme.
The aim is to balance recognition for devices already regulated in the EU and probably the US to prevent reinventing the wheel and focus on innovative devices and devices which are not already approved. It also recognises the regulatory skills gap in the UK compounded by the global skills gap in this area and is looking to create a skills programme.
It is great to understand more about the direction of travel in the UK and industry will be heartened that the UK is trying to avoid unnecessary bureaucracy whilst still protecting its patients; however, the devil is always in the detail and many manufacturers are already anxious to start planning for 2024, they will be watching for the next output to understand the volume of work needed to maintain devices on the UK market.
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