BIVDA broadly welcomes the publication of the draft Pre-Market Statutory Instrument on the WTO website by the MHRA.
This draft SI provides an important indication of the future direction of the UK Medical Devices Regulations and demonstrates continued progress towards greater international harmonisation.
We recognise the significant effort that has gone into reaching this stage and welcome the collaborative and open approach the MHRA has taken throughout the development process, including its ongoing engagement with industry and stakeholders across the sector.
We look forward to continuing to engage with our members, international IVD stakeholders, and the MHRA as the proposed pre-market regulatory changes are reviewed, refined, and implemented.
Members can provide their views on the proposed changes in the MHRA survey here, which closes at 11:59pm on Friday 19 June 2026.
