In yet another setback to the UK's implementation of an independent regulatory framework following Brexit, the government has once again delayed the introduction of mandatory UKCA Marking for industrial products until 2025.
The UKCA Mark was originally due to become mandatory for industrial products in Great Britain from 1 January 2022. That deadline was postponed in August 2021 until 1 January 2023 and has now been postponed again until 1 January 2025, ostensibly to spare businesses the regulatory burden at a time of difficult economic conditions caused by the pandemic and Putin's war in Ukraine.
In the meantime, the UK will continue to unilaterally recognise the European Union's CE Mark, which indicates compliance with the EU's regulatory framework. Businesses will have the option to affix a UKCA Mark to their industrial products if they so choose.
Based on coverage in the Financial Times (behind paywall), industry figures have welcomed this latest postponement, but warned that it has only created a new "cliff edge" for compliance in 2025. According to that article, the UKCA Mark scheme remains deeply unpopular with industry as it is "burdensome, expensive and impractical". The British Chamber of Commerce has called for the deadline for UKCA Marking to be further extended to 2026, and MakeUK has called for the UK to agree a long-term mutual recognition agreement with the EU in respect of industrial standards. Such an agreement would allow industrial products bearing either the UKCA Mark or the CE Mark to be sold throughout the European Economic Area, Northern Ireland and Great Britain.
Does this affect UKCA Marking for medical devices?
This latest announcement has no effect on the introduction of UKCA Marking for medical devices and in vitro diagnostic medical devices. We have written previously about the UK's plans to introduce a new post-Brexit regulatory framework on medical devices and in vitro diagnostic medical devices. It was recently announced that the implementation of the UK's new framework will be delayed by one year until the end of June 2024.
Beyond June 2024, we fully expect that CE Marks affixed under the EU's regulatory framework on medical devices will be unilaterally recognised in the UK under the new framework until at least 30 June 2029. UKCA Marking is unlikely to become truly mandatory for medical devices or in vitro diagnostic medical devices for a long time to come.
Contains public sector information licensed under the Open Government Licence v3.0.