Products | UK Regulatory Outlook September 2025

Jump to:   Product Sustainability  |  Life Sciences and Health

General and Digital 

UK 

Law Commission to review product liability regime 

The Fourteenth Programme of Law Reform was released on 4 September, setting out 10 new projects on which the Law Commission will be providing recommendations for reform. 

One of these projects is "product liability and emerging technologies" with the Law Commission stating the current UK regime for product liability "has not kept pace with the rapid development of emerging technologies, including artificial intelligence (AI) and the increased use of digital products". 

There are five issues that the project will address including: 

• The question of updating the definition of “product” in the Consumer Protection Act 1987 (CPA) to expressly include software, whether supplied via tangible or intangible medium.  
• Whether the “long-stop” liability period of ten years should be extended, given that some products arising from emerging technologies can be upgraded iteratively.  
• Whether the “state of the art” defence should be amended to account for emerging technologies that can be updated iteratively.
• Difficulties for claimants in pursuing claims with respect to highly technical and opaque technology, such as AI.  
• Whether the definitions of “defect” and “damage” in the CPA should be amended to take into account the impact of emerging technologies. 

The Law Commission's statement on product liability in the UK follows a 2023 a government consultation which recognised that reform of the UK's product liability framework was long overdue. In November 2024, the new EU Product Liability Directive was published, with Member States having until 9 December 2026 to transpose the new directive into national law. This new EU Directive addressed issues that appear to be line with concerns that have been raised regarding the current UK legislation. It is possible, if not likely, that the new UK legislation will be designed to line up with the EU regime. While further details are awaited to be published on the changes to UK legislation, Osborne Clarke has produced a guide on preparing for the changes, in both the EU and the UK. 

The timetable for the new product liability reform project has not yet been announced but the full proposal is available to read. 

Independent review of the Windsor Framework released 

Following the Stormont vote of the Northern Ireland Assembly on 10 December 2024 under Article 18 of the Windsor Framework, where the consent vote passed but without cross community support, the secretary of state for Northern Ireland commissioned an independent review into the functioning of the Windsor Framework. 

On 4 September, the Rt Hon Lord Murphy presented his report to the secretary of state for Northern Ireland. This review found persistent cross-community division and a continuing democratic deficit. Specifically, practical challenges in product regulation scrutiny and uncertainty over applicable EU product rules such as the General Product Safety Regulations, calling for a single, plain-English guidance hub and earlier influence on EU proposals via the NI Executive Office in Brussels. 

It will now be up to the government to decide what actions it will take in response to these recommendations. 

OPSS launches consultation on machinery safety legislation 

On 28 July, the Office for Product Safety and Standards (OPSS) launched a consultation regarding whether the government should introduce the same measures as included in the EU Machinery Regulation 2023/1230 across the UK, using the secondary legislation powers granted under the Product Regulation and Metrology Act 2025. 

Specifically, the OPSS is looking for feedback regarding the issues associated with the continued recognition of EU product requirements for machinery, and the implementation of the same approach, including: 

• The introduction of health and safety requirements relating to new and emerging technologies.
• The use of common specifications as a new means of showing conformity.
• The introduction of importer and distributors requirements.
• The introduction of third-party conformity assessment for some products.
• Any other key topic within the legislation that should be considered in detail. 

The consultation is open until 11:59pm on 20 October 2025. 

Consultation on Automated Vehicles Regulations 

The Department for Transport is seeking comments on the proposed Automated Vehicles (Permits for Automated Passenger Services) Regulations 2026 to support the deployment of commercial self-driving pilots. The regulations are aiming to help smooth the introduction of the automated passenger services (APS) permitting scheme by the Automated Vehicles Act 2024. 

The consultation is asking for feedback on the details of the APS scheme and proposed secondary legislation, especially relating to: 

• Consent requirements for permits;
• Accessibility;
• The application process and renewals;
• The process of varying, suspending, or withdrawing a permit;
• The process for potential appeals of decisions relating to permits;
• The disclosure and use of information during the permitting process. 

The consultation has a total of 22 questions and is running until 28 September 2025. 

Outcome of the call for evidence for measuring noise from outdoor equipment 

In September 2024, the OPSS launched a call for evidence considering whether the UK should introduce the same measures in relation to the measuring of noise from outdoor equipment that were being made to European Union Directive 2000/14/EC. 

These changes relate to Annex III – methods to measure airborne noise emitted by equipment for use outdoors – and will bring measures in line with technical progress, simplify work for manufacturers and conformity assessment bodies and reduce reporting requirements. 

The responses to the call for evidence were overwhelmingly in support of implementing the same changes to UK legislation. The government will now consider the changes required to the UK legislation and update the legislation when Parliamentary time allows. 

Product Sustainability 

UK 

Online platforms to pay towards recycling of electrical waste 

The Waste Electrical and Electronic Equipment (Amendment, etc.) Regulations 2025 (SI 2025/910) came into force on 12 August 2025. They include obligations for online marketplaces to report data on sales made by their overseas sellers in the UK and to help fund the clean-up of waste electrical and electronic equipment (EEE) products sold through their platforms. 

Distributors that make EEE available on the UK market, including by distance selling, must: 

• offer free takeback on waste EEE;
• accept WEEE for free from customers supplied with like-for-like products, regardless of whether this is done in store, online or by mail order;
• retain a record of all WEEE taken back for at least four years; and
• provide customers access to written information on the service provided and what they should do with their waste EEE. 

Businesses that fall within scope of these regulations should review these and understand the obligations they need to undertake in order to comply.  

Draft regulations on the banning of the sale of wet wipes containing plastic in England

The draft Environmental Protection (Wet Wipes Containing Plastic) (England) Regulations 2025 were laid before Parliament for approval on 16 September. These regulations will make it an offence to supply or offer to supply single-use wet wipes containing plastic to consumers in England, with exemptions for pharmacies, for medical purposes and supply to businesses or local authorities. Enforcement will be carried out by local authorities with £200 fines or compliance notices being issued to persons convicted under the regulations.

The ban will come into force in England 18 months after the regulations are made, with the Welsh ban coming into force on 18 December 2026 under the Environmental Protection (Single-use Plastic Products) (Wet Wipes) (Wales) Regulations 2025 which were adopted in July. 

Consultation on Welsh deposit return scheme opens 

The Welsh government has launched a consultation to gather feedback to shape the Deposit Return Scheme (DRS) for drink containers in Wales. 

The 26 questions cover topics including supporting the transition to reusable containers, minimum standards for use, handling and logistics, deposit levels, and economic development opportunities associated with the DRS. 

Differing from the approach of the rest of the UK's DRS, it is proposed that glass will be included in the Welsh DRS from the outset using a phased approach to allow for the gradual introduction of reuse and single use glass-related obligations and transitional arrangements to avoid disruption and the need for changes to labelling or production and distribution systems. 

The consultation runs until 10 November 2025 and responses can be submitted here. 

Proposal for a restriction on PFAS substances in firefighting foams 

The Health and Safety Executive has launched a consultation on proposals to develop a UK REACH restriction on per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams. 

The HSE is taking a broad approach to defining PFAS because "a broad definition will minimise potential for regrettable substitution with PFAS not currently known to be used in firefighting foams, but which have the same risks as those already identified". The overall conclusion of the HSE is that a "…the use of PFAS in firefighting foams presents a risk to the environment, and human health via the environment, that is not adequately controlled by measures already in place". The full details of the proposed restriction are available in the Annex 15 Restriction Report and in the published Q&A document. 

The consultation runs until 18 February 2026 and responses can be submitted here. 

While focused on fire-fighting foams, this consultation illustrates how the UK is starting to take steps towards tackling the issue of PFAS. 

EU 

Final PFAS evaluation conclusion to be delivered in 2026  

The European Chemicals Agency (ECHA) has announced its timetable for its evaluation of a potential restriction for PFAS, with a final conclusion expected to be delivered to the European Commission in 2026. 

While ECHA claims that good progress has been made in relation to considering the 14 sectors covered by the original restriction proposal, the additional consideration required by the eight new sectors identified in its updated proposal would apparently push the window for a final opinion to a "significant time beyond 2026". Consequently, the eight new sectors (including medical, military and machinery applications) will not be specifically considered in the final opinion, but will be partially considered as part of the broad horizontal issues. 

Following on from the ECHA's updated timeline, the subsequent proposal by the European Commission is unlikely to be published before 2027, with any restrictions only becoming effective once the proposal has been subject to legislative approval and becoming law. It seems unlikely that any restriction will actually come into effect before 2029 at the earliest, as the rough estimate for the shortest time for a proposal to become law is approximately 18 months under the ordinary legislative procedure; however, the process could take much longer. 

European Parliament adopts new EU rules to introduce EPR for textiles 

The European Parliament has approved legislation aimed at significantly reducing waste from food and textiles across the EU. Under the new legislation, which follows the extended producer responsibility (EPR) regime approach, producers that make textiles available in the EU will have to cover the costs of their collection, sorting and recycling, through new EPR schemes to be set up by each Member State. The provisions apply to all producers, including those using e-commerce tools and irrespective of whether they are established in an EU country or outside the Union. 

The law will now be signed by both co-legislators, ahead of its publication in the EU Official Journal where EU countries will then have 20 months to transpose the new rules into national legislation. The EPR schemes must be set up within 30 months of the directive's entry into force, which will be around the middle of 2028. 

Global plastics agreement negotiations collapse 

UN-based negotiations on a legally binding global plastics agreement fell apart during the second part of the fifth session in the Intergovernmental Negotiating Committee over the course of August 2025. The negotiations followed a UN Environment Assembly initiative in 2022 that resulted in 175 nations endorsing a resolution committing to reaching a draft international agreement to end plastic pollution. 

The treaty proposed to tackle plastic pollution across its entire lifecycle, including production, design and disposal. It was intended to include diverse approaches to dealing with the full lifecycle of plastics and the need for enhanced international collaboration to build capacity and technical cooperation. 

As noted in Ukraine's closing statement, there appeared to be a deep divide between states that sought mandatory restrictions and those that were insisting solely on waste recycling measures. As noted by Barbados in its closing statement, "positions have remained entrenched, and opportunities for convergence [were] allowed to pass by." 

Commission publishes updated guidance on Deforestation-Free Products regulation 

Please see ESG section. 

Life Sciences and Health 

UK 

Government responds to the MHRA consultation on statutory fees 

The government has released an updated proposal in relation to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on statutory fees. This comes after the initially proposed updated fee for Medical Device Registration received overwhelmingly negative feedback with only 10% of respondents supporting it. 

The government's new proposal for the Medical Device Registration fee, which will come into force on 1 April 2026, is for it to be charged at a higher Global Medical Device Nomenclature (GMDN) category (GMDN level 2) rather than GMDN code (level 5). The new fee, which will be in the region of £300 per year, will have a phased implementation. It will be part-subsidised by the government for the 2026-27 financial year, with full cost recovery starting in the 2027-28 financial year. 

Access the full government response (login required). 

Health secretary ends talks with pharmaceutical companies regarding drug pricing 

The dispute between the UK government and pharmaceutical companies regarding drug pricing has been simmering away for several months now, with the uncertainty said to be causing issues with long term planning and economic growth in the sector. 

In the latest move to try and bring matters to a head, Wes Streeting, the UK health secretary, issued a private ultimatum to pharmaceutical companies to accept the government's latest offer on drug pricing by 22 August, or else he would publicly end the talks. In a letter to the Association of the British Pharmaceutical Industry (ABPI), Mr Streeting said that they had been given ample time to consider the "generous" offer put to them in recent weeks, but had "repeatedly delayed" making a decision. At 12pm on 22 August, it was confirmed that Mr Streeting ended talks after the ABPI refused the latest offer. 

The key issue is the rate of a clawback tax on sales that is calculated each year, based on how much NHS spending on drugs outpaces an agreed growth rate, and is designed to limit the cost of medicines available on the NHS. The scheme rate for this year was 22.9% of UK sales, 7.9% higher than the 15% originally forecast. The deal was originally agreed in 2023 and is due to run until 2028 and is voluntary. However, withdrawal means paying the statutory rate instead, at 23.4%. The pharmaceutical sector wants a government commitment to spending a certain percentage of GDP on medicines, as well as to change the regulatory process used to approve new drugs, in a bid to both reduce the clawback tax rate and improve availability in the UK.  

A number of pharmaceutical companies have issued statements regarding their investments in medicines in the UK. At the time of writing there have been no further comments from the government on re-opening negotiations. 

Consultation on the Revised International Council for Harmonisation guidelines 

The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline to capture information for the registration and lifecycle management of pharmaceuticals for human use. 

The aim is to further refine the guidelines that were last harmonised in 2002 to improve efficiency, leverage digital technologies, and accelerate patient and consumer access to pharmaceuticals. 

Responses can be provided via downloading the ICH Public Consultation Comments template and emailing it to ichconsultations@mhra.gov.uk 

Transforming the UK clinical research system: August 2025 update 

On 4 August, the Department of Health and Social Care (DHSC) published a report into the progress made in implementing the recommendations from Lord James O'Shaughnessy on how to resolve challenges in conducting commercial clinical trials in the UK. 

Among the points discussed in the report are a continued commitment to implementing the investment programme for Voluntary Scheme for Branded Medicines Pricing, Access and Growth and the commissioning of new commercial research delivery centres across England and the devolved governments. Also, the UK Clinical Research Delivery programme will continue to support the Study Set-Up Plan, now that both Phase 1 and Phase 2 deliverables have been published. 

With the report showing that a large number of Lord O'Shaughnessy's recommendations are now completely implemented and receiving ongoing support, the DHSC has five broad areas in which it is committed to going beyond the Lord O'Shaughnessy review: 

• Commitments carried forward under the UKCRD programme;
• Research delivery enabled by data and digital tools;
• Reaching 150-day target for setting up clinical trials;
• Delivering transparent data at site and study level; and
• Improving the wider research system 

For more details on the above five areas, see this section of the report. 

MHRA launches framework for decentralised manufacture of personalised medicines 

New regulations introduced by the MHRA came into force on 23 July 2025. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, SI 87/2025 aim to provide the world's first regulatory framework that allows breakthrough personalised medicines such as cancer and immunotherapy (that is, CAR-T) treatments to be prepared in small or individual batches at locations near to the patients that require them. 

The MHRA claims that the new regulations make it possible for a cancer patient, for example, to have their immune cells collected, modified to fight their specific cancer, and returned within days, rather than the months that it can take at the moment. Medicines that only have a shelf life of minutes could be made and given to patients on the spot under the new regulations. 

The new regulations mirror the process that allows chemotherapy drugs and antibiotics to be prepared locally, but have more stringent safeguards in place to account for newer, more advanced therapies, including cell and gene therapies, tissue-engineered treatments, 3D printed products, blood products, and medicinal gases. 

The government has also confirmed that products manufactured at the point of care are eligible for support through the MHRA's Innovative Licensing and Access Pathway and has set up a decentralised manufacture hub to collect guidance to assist manufacturers. 

NBCG-Med and Team-NB outline a governance vision for the future of the EU Medical Device Regulatory System 

On 28 July, the Notified Bodies Coordination Group for Medical Devices (NBCG-Med) and The European Association of Medical Devices Notified Bodies (Team-NB) have jointly published a position paper outlining a governance vision for the future of the EU medical device regulatory system. 

The key proposals include: 

• The creation of a Medical Device Coordination Office (MDCG) to: coordinate notified body designation, classification decisions, and guidance development; oversee early dialogue, special pathways, and expert panel consultation; maintain a central evidence repository for scientific and clinical data; act as the secretariat for MDCG and working groups.
• Emphasising the role of notified bodies as technical, clinical, and regulatory contributors – not just assessors.
• Calling for a hybrid funding model (consisting of both EU funds and stakeholder fees) to ensure the sustainability of central coordination functions.
• Supporting the establishment of Special Pathways and Early Advice mechanisms for innovative, orphan, or paediatric devices — to be coordinated through MDCO, with a robust, multi-party governance process.
• Encouraging enhanced integration of notified bodies into guidance development, scientific committees, and strategic planning — with the aim of preserving expertise and harmonising implementation. 

EU 

European Commission's call for evidence on medical devices and in vitro diagnostics 

The European Commission has launched a call for evidence seeking views on an initiative to simplify EU rules for medical devices and in vitro diagnostics in order to safeguard a high level of patient safety, public health and healthcare. 

The aim is to make safety requirements more cost-efficient and proportionate while making the EU medical device sector more competitive in the internal market and globally. 

The call for evidence closes on 6 October 2025.