in a nutshell
The UK Government has announced that it will postpone the implementation of the upcoming UK Medical Devices Regulations from 1 July 2023 to 1 July 2024.
The MHRA announcement means that CE-marked products will continue to be accepted in the UK, and manufacturers will only be required to obtain the UK Conformity Assessed (UKCA) mark from July 2024. Make sure their products comply with the new UK regime.
This extension is understandable given the lack of post-Brexit regulatory certainty and concerns over the limited number of UKCA conformity assessment bodies.
While the decision was welcomed, there are legitimate concerns about lagging regulatory certainty from industry bodies such as ABHI. ABHI’s director of diagnostics regulation Steve Lee said, “Of course it’s welcome… but progress in the coming months must be rapid and decisive if we are to avoid a similar cliff-edge scenario a year from now. Hmm,” he commented. In the meantime, manufacturers can take advantage of this extension as there will be a longer transition period before products with CE marking can enter the UK market.
However, it is unclear what the new regulation will look like and the industry hopes the new UK regime will work closely with the EU medical regulation 2017/745. The government plans to introduce legislation outlining transitional measures and post-market surveillance requirements by spring 2023.
The full text of the UK Government press release is available here.
For more information and what this development means for you, please contact your regular Baker McKenzie representative.
