BIVDA welcomes MHRA’s formal response to the consultation on future regulation of medical devices in the UK
The response to the consultation on the new UK Regulatory Framework for medical devices was published on 26 June 2022. This is a huge step for regulation in the UK and gives an insight into what can be expected when the regulations are published.
Totalling 16 chapters and spanning 155 pages, the response is very comprehensive and detailed. This depth has been anticipated by the IVD sector, particularly considering the timeline for UKCA compliance is 1 July 2023 (albeit with some domestic assurance and transition periods included).
It appears that the UK will be largely aligning to the EU regulatory route, with a number of UK-specific requirements. Classification will be based on the IMDRF rule structure, and a transition period of 5 years will be introduced for IVDs conforming to the new system. However, new products placed on the market after the implementation date will likely need to fully comply or utilise the domestic assurance routes.
It is clear that the ongoing work by MHRA to ensure a sufficient capacity of UK Approved Bodies is now even more important, and the UK needs to make sure that lessons have been learnt from the lack of Notified Bodies within the EU to safeguard patient safety.
BIVDA Chief Executive Officer, Doris-Ann Williams, said: “It is a relief for industry to have clarity on what can be expected on the IVD regulations in the UK. BIVDA look forward to continuing to work with MHRA going forward and provide support to our membership where needed in navigating this new chapter.”
BIVDA Regulatory Affairs Manager, Ashleigh Batchen, said: “This is a much-needed step in allowing industry and other stakeholders involved to understand what is required of them within the new Regulation. MHRA have done a fantastic job at providing this level of clarity, and we will work with members to ensure they have a strong understanding of these requirements.”
BIVDA will continue to work with key stakeholders to support in this transition to avoid disruptions in the supply of life-saving diagnostics.
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For more information on BIVDA’s Regulatory Affairs function and workplan for 2022, please contact ashleigh@bivda.org.uk