Products | UK Regulatory Outlook March 2026

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General/digital products  

Consultation on a general safety requirement for unregulated construction products 

The Ministry of Housing, Communities and Local Government has launched a consultation seeking views on proposals to introduce a general safety requirement for construction products that are not currently subject to specific regulation. The proposals would require that such products placed on the market are safe, and would establish obligations for businesses across the supply chain (including importers, distributors and merchants) alongside enforcement powers for the national regulator for construction products. 

The proposals cover mandatory risk assessment, product information, labelling and traceability, record keeping, and storage and transportation requirements, as well as measures for monitoring safety issues. The consultation closes on 20 May. 

Separately, the British Standards Institution has published PAS 2000:2026, a new code of practice for construction product manufacturers on bringing safe products to market. Developed following a recommendation from the Grenfell Inquiry, it sets out a practical framework for manufacturers to demonstrate that they have taken reasonable steps to ensure product safety, covering pre-market risk assessment, factory production control, product documentation, and the collection and use of market feedback.  

The new regime, expected to come into force in 2027, will affect manufacturers, importers, distributors and merchants whose products are currently unregulated, which is estimated to be around two-thirds of the market. Businesses across the supply chain should consider engaging with the consultation before 20 May. 

Commission consults on draft guidance for the EU Cyber Resilience Act 

The European Commission has published draft guidance to assist businesses in applying the Cyber Resilience Act (Regulation (EU) 2024/2847), with a particular focus on micro-enterprises and small and medium-sized enterprises.  

While the CRA applies in full from 11 December 2027, certain provisions come into force earlier: Chapter IV from 11 June 2026 and certain reporting obligations from 11 September 2026. 

The non-binding guidance clarifies provisions for manufacturers, developers and other stakeholders, covering when standalone software and free and open-source software fall within scope, what constitutes a data connection, how cybersecurity requirements for complex systems should be assessed, when hardware or software modifications qualify as substantial modifications, and how to determine whether a product has a remote data processing solution. The Commission invites comments by 31 March. 

Any business that manufactures or sells hardware or software products with digital elements on the EU market should review the draft guidance. With reporting obligations applying from September 2026, businesses should actively progress their CRA compliance programmes, particularly around vulnerability reporting systems and conformity assessment readiness. 

Government response to the machinery safety call for evidence: strong support for continued EU alignment 

The UK government has published its response to the call for evidence on machinery safety legislation, which sought views on whether Great Britain should continue to recognise EU rules on machinery and whether future UK legislative reforms should take a similar approach to the EU. 

Of the 48 responses received, 45 were in favour of continued recognition of EU product requirements (including CE marking), and 43 were in favour of adopting a similar approach in GB legislation. Respondents cited efficiency, reduced administrative burdens, and the importance of maintaining access to EU and Northern Ireland markets as reasons for supporting alignment. Those opposed wanted the UK to go further by setting higher safety standards. 

The government has indicated it will lay legislation to continue CE recognition for machinery products in Great Britain, and will update the Supply of Machinery (Safety) Regulations 2008 to introduce measures aligned with the EU Machinery Regulation 2023/1230, which substantively applies from January 2027. Full replication of EU rules is not possible, as any GB legislation must be tailored to national requirements, such as omitting references to EU institutions and providing for UK conformity assessment bodies and the UKCA marking. 

Manufacturers, importers and distributors of machinery in Great Britain should begin reviewing their product classifications against the EU Machinery Regulation 2023/1230. Connected and AI-enabled machinery is likely to face additional requirements, including third-party conformity assessment, and businesses should monitor progress of the secondary legislation accordingly. 

Tobacco and Vapes Bill: amendment to delay implementation defeated in House of Lords 

On 3 March, a government-backed majority in the House of Lords defeated an amendment at report stage that would have required a minimum 12-month lead-in period before the new retail licensing regime for tobacco and vape products under the Tobacco and Vapes Bill could take effect.  

Supporters of the amendment argued that more time was needed for retailers, local authorities and specialist tobacconists to prepare for the administrative and financial burden of the new licensing system. The government opposed it on the basis that a fixed delay written into primary legislation would be too rigid, and maintained that retailers would receive appropriate notice through secondary legislation and consultation. 

The defeat of this amendment means the licensing regime could come into force with less notice than the retail trade had hoped for. Retailers selling tobacco or vape products should begin assessing their licensing requirements, reviewing staff training and point-of-sale systems. 

Life sciences and healthcare

UK 

MHRA consults on indefinite recognition of CE marked medical devices 

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a targeted consultation on proposals for the recognition of CE-marked medical devices in Great Britain, open until 10 April 2026.  

The proposals include extending transitional arrangements for devices complying with the Medical Device Directive to align with EU timelines, indefinitely recognising devices compliant with the EU Medical Devices Regulation and EU In Vitro Diagnostic Medical Devices Regulation, and introducing an international reliance route for devices classified at a higher risk level in Great Britain than in the EU. 

Around 90% of devices on the GB market currently rely on CE marking. Indefinite recognition, if adopted, would remove the need for separate UKCA conformity assessment for most products, providing long-term certainty and reducing duplicative compliance costs. Manufacturers and distributors should consider reviewing the proposals and submitting a response before 10 April, as the outcome will shape the GB regulatory framework.. 

House of Lords inquiry launched into personalised medicine and AI in the NHS 

The House of Lords Science and Technology Committee has launched an inquiry into innovation in the NHS, with a focus on personalised medicine and artificial intelligence.  

It will examine the current state of genomics and AI-driven diagnostics, the barriers preventing proven innovations from being deployed across the NHS, and how the NHS and regulators should balance the evaluation of new treatments with making them available to patients.  

The committee is also seeking views on what strategic action the government should take to strengthen the relationship between medical research, the life sciences industry and the NHS. Evidence is sought by 20 April. 

This is an opportunity for businesses developing personalised medicines or AI-enabled healthcare technologies to influence policy recommendations on NHS procurement, regulatory evaluation timelines and innovation deployment. Relevant businesses should consider submitting evidence by 20 April. 

MHRA publishes updated guidance ahead of clinical trials regulations amendments 

The MHRA has published and updated several guidance documents in preparation for amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004 enacted by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which come into force on 28 April 2026.  

The updates include new draft guidance on good manufacturing practice for investigational medicinal products, with specific provisions for radiopharmaceuticals covering their manufacture, certification, labelling and use in clinical trials. 

The updated and new guidance documents include: 

• Clinical trials for medicines: modifying a clinical trial approval
• Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products
• Clinical trials that include an in vitro diagnostic device
• Clinical trials: non-investigational medicinal products
• Clinical trials for medicines: labelling
• International Council for Harmonisation (ICH) annotations 

With the changes taking effect on 28 April, pharmaceutical manufacturers, clinical research organisations and trial sponsors should review the updated guidance and update their internal processes, trial protocols and good manufacturing practice documentation accordingly. 

NICE cost-effectiveness threshold: ministers granted power of direction under new regulations 

The National Institute for Health and Care Excellence (Amendment) Regulations 2026 were laid before Parliament on 3 March 2026. The amended regulations grant ministers a limited power of direction to set the standard cost-effectiveness threshold that NICE applies when developing guidance, including technology appraisal and highly specialised technology evaluation recommendations, and remove the requirement for NICE to consult on procedural changes arising from a ministerial direction. The regulations come into force on 24 March 2026. 

The NICE cost-effectiveness threshold is central to whether new treatments and technologies are recommended for NHS use. Pharmaceutical and medical technology businesses should monitor how ministers use this new power and factor potential threshold adjustments into their market access planning and health economic modelling. 

UKRI publishes first artificial intelligence strategy with £1.6bn in funding through to 2030 

UK Research and Innovation has published its first artificial intelligence strategy, setting out how AI will be embedded across the UK's research and innovation landscape.  

The strategy confirms £1.6bn in targeted funding through to 2030 and identifies six priority areas: advancing AI technology development; transforming research through AI; developing AI skills and talent; driving innovation to support economic growth and societal outcomes; promoting responsible and trustworthy AI; and building data and computing infrastructure. 

Specific commitments include up to £137m to support AI-enabled scientific discovery, with an initial focus on drug discovery and new treatments, and £36m to upgrade the University of Cambridge's DAWN supercomputer. 

Life sciences and AI technology businesses should review the funding opportunities available through UKRI and consider how partnerships with the research and innovation community could align with the strategy's priority areas, particularly around drug discovery and AI-enabled diagnostics. 

EU 

EMA publishes draft guidance on clinical trials during public health emergencies 

The European Medicines Agency has published draft guidance from the Accelerating Clinical Trials in the EU (ACT EU) initiative on the conduct of clinical trials during public health emergencies, open for consultation until 30 April 2026.  

The guidance recommends a harmonised approach to ensure trials can be initiated, adapted and continued efficiently and safely during emergencies, and outlines regulatory mechanisms to accelerate authorisation of new trials and modifications to existing ones. It also encourages sponsors to seek scientific advice from the EMA's Emergency Task Force and addresses the transfer of trial participants across investigational sites. 

Drawing on lessons from the Covid-19 pandemic, the guidance constitutes a standing framework that permits certain adaptations (such as remote consent, direct-to-patient delivery of investigational medicinal products and remote monitoring) while setting clear boundaries on changes that remain unacceptable even during emergencies.  

Pharmaceutical companies and clinical research organisations should review the guidance as part of their emergency preparedness planning and consider submitting comments to the EMA before 30 April. 

Sustainable products 

UK 

House of Lords debate on PFAS 'forever chemicals' in consumer products 

The House of Lords has debated the government's approach to regulating per- and poly-fluoroalkyl substances (PFAS), following a question from Baroness Ritchie of Downpatrick on whether the government's PFAS Plan, published on 3 February, would include an option to ban PFAS in all consumer products manufactured or sold in the UK.  

The government indicated that the plan sets out its approach to minimising harm and transitioning to safer alternatives, but that there are no current plans to consult on an outright ban. It confirmed it will apply the precautionary principle when assessing PFAS risks and is engaging with industry and monitoring EU developments, as the EU is developing its own broad PFAS ban.  

Peers across parties raised concerns about PFAS in products including babies' mattresses, school uniforms and period products, as well as water contamination, and warned the UK risks becoming a dumping ground for products banned in the EU. 

The direction of travel is towards more comprehensive regulation and greater transparency requirements. Businesses that use PFAS in consumer products should map their exposure across products and supply chains now, assess how EU restrictions may affect cross-border sales, and monitor upcoming UK REACH reform consultations. 

UK REACH candidate list: new strategic approach to substances of very high concern 

The government has published a policy paper setting out a new approach to the UK REACH candidate list of substances of very high concern (SVHCs). These are substances with carcinogenic, mutagenic or reprotoxic properties, or those that are especially persistent and bio-accumulative in the environment.  

Inclusion on the candidate list places additional communication and notification duties on suppliers and can be a precursor to inclusion on the authorisation list, which restricts use of a substance after a specified sunset date. 

The new approach, which took effect on 24 February 2026, replaces the interim principles that had applied since the UK's exit from the EU in 2021. The Department for Environment, Food and Rural Affairs and the devolved governments of Scotland and Wales have indicated that substances added to the EU REACH candidate list since 1 January 2021, and future EU additions, will be reviewed and added to the UK REACH candidate list "where appropriate", with the aim of aligning more closely with the EU and reducing business complexity. 

Separately, the REACH (Amendment) Regulations 2026 have been laid, adding further restrictions on the use and placing on the market of lead and its compounds under Annex 17. Those restrictions come into force from 1 April, with transition periods applying. See environment section for more details. 

Closer alignment with the EU REACH candidate list means businesses that already comply with EU SVHC obligations will find UK duties easier to meet, but the candidate list will expand more rapidly.  

Manufacturers, importers and distributors should audit their products against EU REACH candidate list additions since 2021, review the new lead restrictions taking effect from 1 April, and establish processes to monitor future UK updates. 

Year 1 EPR for packaging: government steps in to cover funding shortfall 

PackUK has confirmed that disposal fees for Year 1 of the extended producer responsibility for packaging (pEPR) scheme will remain unchanged from those set out in producers' notices of liability in October 2025.  

A shortfall arose after producers resubmitted more accurate packaging data, resulting in lower reported tonnages than originally calculated. This would normally have triggered a recalculation of per-tonnage fees. The government has agreed to cover the shortfall on a one-off basis. Local authorities across the UK will receive the payments they were expecting, with the scheme set to provide £1.4bn in the 2025/26 financial year. 

The government's intervention provides short-term certainty, but producers should treat this as a prompt to invest in robust data collection and submission processes.  

PackUK operational plan 2026-27: eco-modulation fees to apply in Year 2 

PackUK has published its operational plan for 2026 to 2027, setting out its priorities as scheme administrator for the UK's pEPR scheme. A central development for Year 2 is the introduction of eco-modulation, under which producer fees will be differentiated based on the recyclability of packaging.  

Fees will be categorised as green, amber or red under the recyclability assessment methodology (RAM), with illustrative fee rates having been published in December 2025. Year 2 (2026-27) is the first year in which RAM ratings will directly affect fees. 

Producers are required to submit RAM data for the second half of 2025 (H2) by 1 April 2026. Where producers did not include RAM data in their first-half (H1) submissions, PackUK will apply ratios from their H2 data to calculate H1 figures, though H1 data may be resubmitted at a later date.  

PackUK has forecast total fee recovery of approximately £1.56bn for the year. To improve stability, it will cease accepting new local authority data after 1 May 2026 and will limit recalculations of producer notices of liability to set points in the year. 

With the H2 2025 RAM data deadline of 1 April 2026 imminent, producers should prioritise accurate data submissions and review their packaging portfolios against the green/amber/red categorisations. Those using less recyclable packaging will face higher fees, creating a direct financial incentive to consider reformulation ahead of the forthcoming RAM 2027 update, due by 1 July 2026. 

Updated waste separation requirements for recycling in Wales 

See environment section. 

EU 

EU Critical Raw Materials Act: Council adopts position on supply security and circularity 

The Council of the European Union has adopted its position on amending the Critical Raw Materials Act (Regulation 2024/1252), which would shift responsibility for identifying large companies using critical raw materials from Member States to the European Commission. 

The Council's position requires the Commission to inform Member States and the European Critical Raw Materials Board about identified companies and their vulnerabilities, clarifies the Commission's authority to propose risk-mitigation measures, and permits the use of digital product passports for information on permanent magnets. Negotiations with the European Parliament will begin once it has adopted its own position. 

Large EU industrial businesses using critical raw materials, particularly in defence, clean energy and advanced manufacturing, should monitor the trilogue negotiations, assess their supply chain exposure, and consider digital product passport readiness. 

Pallet wrapping and straps exempted from reuse requirement under EU PPWR 

The European Commission has adopted a delegated decision exempting wrapping and straps used to secure goods on pallets during transport from the 100% reuse requirement under the Packaging and Packaging Waste Regulation (Regulation 2025/40).  

The exemption reflects the Commission's conclusion that requiring exclusively reusable solutions for these items would impose disproportionate costs on operators. The core obligation to achieve 40% reusability for transport and sales packaging by 2030 remains in force. 

Businesses in logistics, manufacturing and retail should update their PPWR compliance plans to reflect the exemption, while ensuring their overall reusability trajectory remains on course for the 2030 targets. 

Commission launches call for feedback on Environmental Omnibus 

See ESG.