Products | UK Regulatory Outlook April 2026

Jump to: Life Sciences and Healthcare | Sustainable products

General/digital products  

Government launches three consultations on overhaul of UK product safety law 

The UK government has published three consultations under the Product Regulation and Metrology Act 2025, proposing the most significant overhaul of UK product safety law in 20 years.  

The existing General Product Safety Regulations 2005 are two decades old and have been stretched by the growth of e-commerce and the emergence of new product risks, leaving the UK increasingly out of step with the EU, which replaced its equivalent directive with a new General Product Safety Regulation in December 2024.  

All three consultations close on 23 June 2026. Read this Insight for a full breakdown of the proposals. 

DfT publishes guidance for self-driving vehicle pilot schemes 

The Department for Transport (DfT) has published guidance for operators seeking to participate in a new self-driving vehicle pilot scheme, which for the first time permits the operation of self-driving vehicles on public roads without a safety driver present. The scheme is distinct from existing automated vehicle trials, which continue to require an in-vehicle safety driver, and is intended to bridge the gap between those trials and full commercial deployment ahead of the complete regulatory framework under the Automated Vehicles Act 2024, expected to be in force from late 2027. 

Participation is subject to a layered approval process. Vehicles must be formally assessed and listed as self-driving, operators must obtain a Vehicle Special Order where existing construction and use requirements cannot be met, and vehicles must be registered under the Automated and Electric Vehicles Act 2018.  

Where a pilot involves carrying passengers, an additional Automated Passenger Service permit will be required under the Automated Vehicles Act 2024.  

Operators must also demonstrate robust safety and incident management arrangements, including incident detection and escalation procedures, emergency response protocols and post-incident cooperation with the DfT, as well as addressing cybersecurity risks across their operations. 

Applications may be made from spring 2026 by organisations in England, Wales and Scotland involved in the operation, supply or deployment of self-driving vehicle services. 

EU Customs Code reform: agreement reached on platform responsibility and product compliance 

The European Parliament and Council reached an informal agreement on 26 March 2026 on what has been described as the most significant reform of the Union Customs Code since the creation of the Customs Union in 1968. The agreement is subject to formal approval by both institutions before it enters into force, with full application expected 12 months after publication in the Official Journal. 

The reform has four principal elements. First, a new EU Customs Authority will be established to coordinate risk assessment and enforcement across Member States.  

Second, a centralised EU Customs Data Hub will replace fragmented national customs IT systems, becoming operational for e-commerce goods on 1 July 2028, opening voluntarily to other traders from 2031, and becoming mandatory for all goods movements by 2034.  

Third, e-commerce platforms and sellers facilitating distance sales of goods from non-EU countries to EU consumers will be treated as importers, responsible for submitting accurate customs data, paying duties and ensuring compliance with EU product safety law. The existing €150 duty-free threshold for low-value parcels will be eliminated, with a flat-rate duty of €3 applying to items valued below €150 from 1 July 2026. Companies that repeatedly fail to comply may be fined between 1% and 6% of the total value of goods imported into the EU in the previous 12 months and risk suspension or revocation of trusted trader status.  

Fourth, a new "trust and check" regime will allow businesses with strong compliance records and a high degree of transparency to benefit from fewer physical checks and greater flexibility on duty payments. 

European Commission's 2025 Safety Gate Report records highest ever number of alerts 

The European Commission's annual Safety Gate report recorded 4,671 alerts in 2025, the highest number since the system launched in 2003 and a 13% increase on 2024, alongside a record 5,794 follow-up actions by national authorities.  

The most frequently reported dangerous products were cosmetics (36%), toys (16%) and electrical appliances and equipment (11%), with risks from dangerous chemicals accounting for more than half of all notifications, followed by risks of injury and choking. 

Looking ahead, the Commission is preparing a 2026 product safety sweep to check compliance with the General Product Safety Regulation online and is organising Coordinated Activities under which national authorities will test specific products and share best practices. It has also announced it will update market surveillance rules through the upcoming European Product Act later this year.  

For businesses placing products on the EU market, the report signals an increasingly active enforcement environment, with national authorities using their stronger powers following the introduction of the General Product Safety Regulation. 

Government publishes response to call for views on cyber security of enterprise-connected devices 

See cyber security section. 

Life sciences and healthcare 

UK 

MHRA secures £3.6 million to expand AI medical device sandbox 

The Medicines and Healthcare products Regulatory Agency (MHRA) has secured £3.6 million over three years to expand its AI Airlock programme, the UK's first regulatory sandbox for AI as a medical device, with the Department of Health and Social Care committing £1.2 million a year from 2026 to 2029. 

The multi-year funding will allow the programme to scale beyond the constraints of annual financial cycles, supporting more ambitious, longer-term testing models and a more sustainable regulatory pathway for AI medical technologies. Phase two has examined regulatory challenges including pre-determined change control plans, AI-powered diagnostic tools and scope expansion, with reporting expected in summer 2026. Phase three details and an application process will follow later in the year. 

For developers and deployers of AI medical devices, the AI Airlock represents a rare opportunity to work through real-world regulatory challenges with the MHRA before the broader framework for regulating AI in healthcare is settled. Insights from the programme are already informing the National AI Commission's work in this area. Those with relevant technologies in development should watch for the phase three call for applications. 

HRA outlines new legal transparency requirements for clinical trials ahead of April 2026 implementation 

From 28 April 2026, sponsors of UK clinical trials will for the first time be legally required to register each trial in a public registry, publish a summary of results within 12 months of the global end of trial, and offer a lay summary of results to participants within the same timeframe. Non-compliance will constitute a criminal offence.  

The MHRA can take enforcement action including infringement notices and prosecution, and can refuse to approve future trials where a sponsor has failed to rectify past non-compliance. 

Transitional arrangements apply to ongoing studies. Trials approved before 28 April 2026 but ending on or after that date must be registered, but are not subject to the lay summary obligation. Registration is required by 27 July 2026 where the first participant has already been recruited. Trials ending before 28 April 2026 are not subject to the new requirements, though existing ethics committee conditions continue to apply. 

UK-US pharmaceutical partnership finalised 

The government has published the full agreed text of its UK-US pharmaceutical partnership, first announced in December 2025 and forming part of the broader UK-US Economic Prosperity Deal.  

The arrangement outlines shared commitments to improve access to medicines, support pharmaceutical innovation, and grow trade in the life sciences sector, with the aim of safeguarding the UK's medicines supply chain and driving investment.  

UK pharmaceutical exports to the US, worth at least £5 billion annually, will be subject to 0% tariffs for at least three years, making the UK the first country to secure this position, with equivalent preferential terms secured for medtech exports over the same period.  

The partnership also introduces stronger incentives for pharmaceutical companies to launch innovative treatments in the UK, enhanced cooperation between the MHRA and the US FDA on medical device regulation, and work towards mutual recognition of medical device approvals. The Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) headline payment percentage will be capped at 15% until the scheme expires on 31 December 2028. 

MHRA and NICE launch aligned pathway for faster medicines approval 

From 1 April 2026, the MHRA and NICE are running their licensing and value assessment processes in parallel for the first time, with the aim of enabling patients in England to access new medicines three to six months sooner. The change follows commitments in the government's 10 Year Health Plan for England and Life Sciences Sector Plan. 

Alongside the aligned pathway, the two bodies have launched an improved Integrated Scientific Advice service, offering a single entry point, meeting and report, and one payment, while aligning data and evidence requirements where possible. The service is designed to give companies greater certainty about the evidence needed earlier in development, reducing the risk of unforeseen delays. Twenty-seven companies signed up as early adopters in October 2025. The first guidance is expected in June 2026. 

MHRA acts to accelerate phase-out of animal testing in medicines development 

The MHRA has announced that it will offer early review of non-animal data to give developers greater confidence when making marketing applications based on New Approach Methodologies.  

By the end of 2026, companies with a product developed without animal testing will be able to have Module 4 of their Marketing Authorisation application reviewed by the MHRA in advance of a full application, with it providing a non-binding written opinion on the adequacy of the data. 

The move supports the government's long-term strategy to reduce and ultimately replace animal use in drug development, and reflects advances in AI-driven analysis and human-derived cell models that mean some medicines no longer require animal studies to demonstrate safety and efficacy. For developers already working with non-animal approaches, the early review pathway offers a practical route to greater regulatory certainty ahead of a full application. 

Sustainable products 

UK 

Defra confirms revised approach to UK REACH transitional registrations and extends deadlines 

Defra has published its response to the May 2024 consultation on an alternative transitional registration model (ATRm) for UK REACH, setting out a revised approach to the submission of chemical registration information to the Health and Safety Executive during the transition from EU REACH. At the same time, draft regulations laid in Parliament on 24 March 2026 further extend the deadlines for submitting transitional registration information. 

On the ATRm, the government has reduced the information requirements for substances previously registered under EU REACH compared to those being placed on the GB market for the first time, with the HSE aligning GB regulatory decisions with EU decisions on such substances unless there are compelling reasons to diverge.  

The "no data, no market" principle will still apply, meaning registrants must continue to provide hazard information, use and exposure information, chemical safety assessments and reports, substance groups, and data sharing and joint submission information. No additional requirements relating to chemical use or exposure generation will be introduced. 

The draft regulations extend the transitional registration submission deadlines from October 2026, 2028 and 2030 to October 2029, 2030 and 2031 respectively. Compliance check dates are aligned with the new deadlines, and the period during which downstream users and distributors can continue to make protected transitional imports is also extended. 

Defra consults on further reform of the PRN and PERN system 

Defra and the devolved administrations have launched a consultation on further reforming the packaging waste recycling note (PRN) and packaging waste export recycling note (PERN) system, closing on 5 May 2026.  

The consultation follows reforms introduced in January 2026 and forms part of an ongoing process to strengthen domestic recycling capacity and reduce reliance on exporting materials for recycling. 

The proposals focus on reducing fraud and creating a more level playing field between domestic reprocessors and exporters.  

Key measures include establishing a fraud detection initiative to improve market data sharing and cross-regulator cooperation, introducing requirements to ensure all accredited operators base their evidence on packaging content handled after sorting and cleaning, placing time limits on national protocols and agency-agreed industry grades to keep them current, and creating a mechanism to cancel illegitimately issued PRNs or PERNs. An exceptional compliance mechanism is also proposed to address genuine shortfalls in evidence availability, and measures to improve data transparency are intended to support buyer due diligence. 

Packaging producers, reprocessors and exporters should consider engaging with the consultation before it closes on 5 May 2026, with the reforms intended to be in place for the 2027 compliance year. 

New ecodesign and energy labelling regulations for household tumble dryers 

The government has confirmed it will proceed with new ecodesign and energy labelling requirements for household tumble dryers sold on the GB market, following a consultation held between July and August 2025. The outcome is given effect by the Ecodesign for Energy-Related Products and Energy Information (Household Tumble Dryers) Regulations 2026. 

The new regulations raise minimum energy performance standards, increase condensation efficiency requirements, introduce circular economy measures to promote repairability, and improve product labelling to better inform consumer choices.  

Key refinements following consultation include extending the ecodesign transition period to 10 months, making the rescaled energy label including the repairability icon mandatory from the end of that transition period, and minor drafting corrections to align GB requirements with EU regulations.  

Manufacturers and retailers of household tumble dryers should review the new requirements and assess what changes are needed to their products and labelling ahead of 19 January 2027, being the end of the transition period. 

EU 

European Commission publishes guidance on Packaging and Packaging Waste Regulation implementation 

The European Commission has published guidance and accompanying FAQs to support the uniform implementation of the Packaging and Packaging Waste Regulation (PPWR) across the EU.  

The PPWR entered into force in February 2025 and begins to apply from August 2026. It replaces the previous Packaging and Packaging Waste Directive and covers all packaging placed on the EU market, regardless of material or origin. 

The guidance clarifies key definitions including those of manufacturer, producer and importer, and addresses a range of compliance requirements including restrictions on single-use packaging formats, PFAS restrictions in food contact packaging from August 2026, re-use targets, recyclability requirements, extended producer responsibility obligations, and deposit and return system requirements. It also addresses packaging minimisation requirements and the empty space ratio, labelling obligations, and the extent to which Member States may introduce additional national requirements. The accompanying FAQs address practical issues raised by stakeholders since the PPWR's adoption and will be updated on an ongoing basis. 

For businesses placing packaging on the EU market, the guidance and FAQs provide important practical clarity on a regulation that will continue to be fleshed out through further implementing and delegated acts over the coming years.  

European Commission consults on measuring energy consumption of AI models 

See AI section.