Government further delays use of UK product safety marking | UK-wide packaging regulations expected to enter into force in late 2023 | MHRA delay medical device reforms to 2024
Government further delays use of UK product safety marking
From 1 January 2023, businesses were being asked to use the UKCA marking instead of the CE mark, but the government has announced this month that this deadline will be extended by two years to offer businesses flexibility. Businesses now have until 31 December 2024 to apply the UKCA mark and can use the CE mark until that date. The UKCA mark can be used now, so those businesses that have started to use the UKCA mark, or are planning to introduce it, should continue to do so.
If a product has been placed on the GB market with a CE mark before 11pm on 31 December 2024, it does not need to be remarked or recertified to UKCA requirements and can continue to circulate on the GB market until it reaches its end user. This also includes where the CE marked product was conformity assessed and certified under EU conformity assessment procedures before 11pm on 31 December 2024.
The easement of allowing the use of existing certificates for UKCA certification remains the same (until 31 December 2027), but the easement of allowing the marking to be affixed using an accompanying document/with a stick-on label is also being extended to match this deadline, from 31 December 2025 to 31 December 2027.
The rules will differ for some products, including, among others, medical devices, construction products and transportable pressure equipment. In these circumstances, the relevant government bodies will be setting out the specific arrangements.
See our previous Regulatory Outlook for the other measures the government has introduced to make the transition to UKCA mark easier for businesses.
UK-wide packaging regulations expected to enter into force in late 2023
Defra was recently asked what steps it is taking to establish a single, mandatory recycling labelling scheme, to which it responded on 7 November that the requirement to label packaging will be introduced as part of new UK-wide packaging regulations that are expected to enter into force late in 2023.
The extended producer responsibility consultation response set out that it would introduce mandatory recyclability labelling on all product packaging. Producers will be required to label packaging to indicate whether it is recyclable or not. This single approach to labelling across the UK aims to provide consumers with clear and consistent information to help them to recycle correctly, which in turn will reduce confusion over what can be recycled, in a bid to increase recycling rates and reduce contamination in recycling waste streams.
MHRA delay medical device reforms to 2024
Medical device manufacturers placing products on the market in Great Britain face a range of regulatory challenges, including the advent of the new UKCA marking regime (replacing CE marking), the lack of capacity among UK approved bodies to certify applicable medical devices and uncertainty over the future regulation of medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) circulated a letter on 21 October 2022 that aimed to address these concerns. Businesses will now have more time to prepare for the new UKCA marking regime and comment on draft medical device regulations. On 25 October, the MHRA published a decision confirming that it will introduce a 12 month extension to the implementation of the future Medical Device Regulations, noting that it aims to bring the new regulations into force by July 2024. Read our Insight for more.
UK lays out roadmap for regulation of software and AI as medical devices
The MHRA has published its "roadmap" for regulating software as a medical device and artificial intelligence as a medical device. The roadmap updates the MHRA's original publication last autumn, in which it set out its regulatory focus areas as part of the wider post-Brexit proposed reforms for medical device regulation in the UK. It offers 11 easy-to-navigate work packages and the steps it will take. Our Insight explores what "deliverables" the MHRA wants from the roadmap and what can be expected from its work packages.
MHRA updates guidance on borderline products
The MHRA has updated its guidance "Borderline products: How to tell if your product is a medical device" by adding a "Risk classification of medical devices" section. This section outlines how, under Part II of the UK Medical Devices Regulations 2002, it gives a system for classifying medical devices into different risk classes and provides factors that will determine which classification a medical device will fall into.