Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market.
The move is a significant reversal of the UK’s previous, post‑Brexit policy. In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark. However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely. Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it. Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU. What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers.
Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”). The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)