On 26th June 2022, the UK Government outlined the results on the consultation on the future regulation of medical devices in the United Kingdom. A key area of concern for manufacturers and Approved Bodies alike are the transition plans outlined in section 15. The following slides represent the current position of LNE-GMED UK after first review of the consultation document. However, we will be working with the UKAB Task Force and Team NB to ensure that a coherent and aligned position is maintained for manufacturers placing products on the GB market.
It should be noted that these transition requirements are not yet documented into UK regulation and as such are subject to change.
To download the full document: “Government response to consultation on the future regulation of medical devices in the United Kingdom”