Products | UK Regulatory Outlook June 2026
Published on 30th June 2026
General/digital products: DSIT publishes Digital Standards Strategy | Government consults on statement of safety principles for automated vehicles | EU legislators agree deal on digitalising product compliance across the single market | DBT surveys battery sector on upcoming EU Battery Passport requirements | European Commission calls for evidence on revised EU tobacco rules | European Commission launches Technological Sovereignty Package covering chips, cloud and AI
Life sciences and healthcare: MHRA consults on new regulatory framework for rare disease therapies | High Court grants first website blocking order targeting counterfeit prescription medicines | Health bill committee calls for written evidence ahead of line-by-line scrutiny | MHRA advances regulatory framework for AI in healthcare | Commission publishes updated guidance on Joint Clinical Assessments | EUDAMED registration now mandatory for medical device market access in the EU | EMA, Commission and HMA publish revised ACT EU workplan for 2026 to 2027
Sustainable products: HMRC consults on mandatory certification for recycled plastic packaging | Government confirms plans to introduce mandatory deforestation due diligence for GB supply chains | EU Packaging and Packaging Waste Regulation: first compliance deadlines in August 2026 | ESPR ban on destruction of unsold clothing and footwear comes into effect next month | Major food and beverage companies lobby for delay to EU packaging regulation | EU's revised Waste Shipment Regulation enters into force alongside new digital tracking platform
General/digital products
UK
DSIT publishes Digital Standards Strategy
The Department for Science, Innovation and Technology (DSIT) has published its Digital Standards Strategy, setting out how the UK will seek to influence the development of international digital technical standards. The strategy covers AI, cybersecurity, advanced connectivity technologies, quantum technologies, semiconductors and the internet. It aims to support economic growth, protect national security and ensure that international standards reflect UK values and interests, and aligns with the UK Industrial Strategy, Trade Strategy and National Security Strategy.
The strategy acknowledges that the digital standards landscape is increasingly complex, with outcomes shaped by industry trends, national ambitions and geopolitical dynamics, and commits the UK to active engagement with industry, the tech community and international partners. It notes that digital standards can complement regulation and reduce red tape by providing a more flexible alternative to regulation, establishing internationally agreed best practice that can adapt more quickly to technological change. Developers, manufacturers and operators in the priority technology areas should monitor emerging standards developments and engage with DSIT's consultation mechanisms as the strategy is implemented.
Government consults on statement of safety principles for automated vehicles
The Automated Vehicles Act 2024 establishes the legal foundation for the safe deployment of self-driving vehicles on public roads in Great Britain, introducing a whole-life safety framework covering type approval, authorisation and ongoing in-use regulation. At the heart of that framework is the statement of safety principles (SoSP), which sets out the safety standard to which automated vehicles must comply and to which the secretary of state must have particular regard when considering whether a vehicle can travel safely and autonomously at the authorisation stage. The Department for Transport has now published a consultation on the draft SoSP.
The draft proposes a safety standard equivalent to that of careful and competent human drivers, which aligns with the UNECE automated driving systems regulation currently in development internationally and expected to come into force in early 2027. The government has noted that setting a higher standard would risk placing requirements on developers beyond those specified internationally, potentially delaying deployment of automated vehicles on GB roads.
The draft SoSP sets out 10 safety principles covering areas including compliance with traffic laws and the Highway Code, vehicle control, hazard detection and response, adaptability to road and weather conditions, predictable behaviour, road safety for all, interaction with vulnerable road users and emergency services, operating within authorised limits, and accounting for the specificities of the territory of operation. Developers and manufacturers of automated vehicles should review the draft principles and consider responding to the consultation, as the SoSP will directly govern the authorisation process.
EU
EU legislators agree deal on digitalising product compliance across the single market
European Parliament and Council negotiators have reached a provisional agreement on measures to digitalise product compliance requirements across the EU single market, forming part of the fourth Omnibus simplification package.
The agreement amends 20 pieces of EU product legislation and introduces a "digital by default" principle, covering the digitalisation of declarations of conformity, mandatory electronic exchanges between economic operators and competent authorities, and the introduction of a direct digital contact point enabling consumers and competent authorities to reach operators directly. Product instructions may be provided in digital format, though safety information must remain available on paper or marked on the product. Consumers will be able to request paper documentation for up to two years following purchase.
The agreement also introduces "common specifications" as a legally recognised fallback mechanism that the Commission may adopt on a temporary basis, lasting 48 months from entry into force, where harmonised standards are unavailable or insufficient. The measures will apply 30 months after formal entry into force, following adoption by both institutions.
Manufacturers and other economic operators placing products on the EU market should begin assessing what changes to their compliance documentation processes and communication infrastructure will be required ahead of that deadline.
DBT surveys battery sector on upcoming EU Battery Passport requirements
The Department for Business and Trade (DBT) is seeking views from the battery sector on the EU Battery Passport requirements that will apply from February 2027 to all batteries placed on the EU market, including those subject to preparation for re-use, repurposing or remanufacturing. The requirements will necessitate the collection, management and reporting of information across the battery lifecycle, covering carbon footprint, materials, performance and supply chain due diligence. The survey closes on 10 July 2026.
The exercise is aimed at manufacturers of batteries and battery-containing products exported to the EU and their supply chains, from raw materials and components through to cells, modules, packs, reuse, recycling and lifecycle assessment, across sectors including automotive, energy storage, defence and maritime. The DBT has confirmed that the exercise is information-gathering only and does not represent a consultation or a statement of future UK government policy. Manufacturers and exporters in scope should consider responding before the deadline.
European Commission calls for evidence on revised EU tobacco rules
The European Commission has published a call for evidence for an impact assessment in connection with a proposed revision of the Tobacco Products Directive and Tobacco Advertising Directive. The call for evidence seeks views on how the existing framework should be updated to address recent market developments, consumption trends and digital marketing practices, with a legislative initiative currently indicated for December 2026.
The Commission is developing policy options around extending the scope of the legislation to cover novel products not currently addressed by the directives. These include nicotine pouches, heated herbal products and electronic non-nicotine delivery systems, introducing rules on flavours in e-cigarettes, disposable e-cigarettes and tobacco heating devices, strengthening rules on labelling and packaging including plain packaging, strengthening digital marketing and advertising rules, and simplifying certain existing provisions. Manufacturers and distributors of tobacco and related products with EU market exposure should monitor the initiative as it develops ahead of the December 2026 legislative timetable.
European Commission launches Technological Sovereignty Package covering chips, cloud and AI
See AI section.
Life sciences and healthcare
UK
MHRA consults on new regulatory framework for rare disease therapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on a proposed rare disease therapies framework, designed to address the scientific, evidentiary and commercial barriers that prevent rare disease therapies from reaching patients under conventional development models.
The framework would introduce an Investigational Marketing Authorisation, a single flexible authorisation that would allow controlled early access to a therapy while further clinical and real-world evidence continues to be generated, with a clear pathway to transition to a full Marketing Authorisation where appropriate. The framework is technology-agnostic and places significant emphasis on patient engagement, including ongoing informed consent throughout the development process.
The consultation is open to manufacturers, developers, clinicians, researchers, patient organisations, carers and other stakeholders and closes on 30 July.
High Court grants first website blocking order targeting counterfeit prescription medicines
In Novo Nordisk A/S v British Telecommunications Plc [2026] EWHC 1094 (Ch), the Chancery Division has granted the first website blocking injunction targeting the supply of counterfeit and unlicensed prescription-only medicinal products. The application was brought against internet service providers at the request of the MHRA, which had been unable to take down four websites selling counterfeit and unlicensed semaglutide and liraglutide products, including counterfeit and unlicenced versions of Ozempic and Wegovy.
The key issue was whether the court had jurisdiction to grant a website blocking order on the basis of criminal wrongdoing under the Human Medicines Regulations 2012, rather than solely for the enforcement of intellectual property rights. Mellor J held that it did, confirming that the equitable jurisdiction to order a facilitator to take steps to prevent wrongdoing by a third party with which it is unwittingly mixed up is not limited to civil wrongs, and that there is no relevant distinction in equity between being mixed up in a civil or a criminal wrong. The target websites' conduct encompassed trade mark infringement, passing off and multiple criminal offences under the regulations.
The decision is significant in extending the reach of website blocking orders beyond the intellectual property context, and may have broader implications for enforcement against online platforms facilitating other categories of criminal wrongdoing.
Health bill committee calls for written evidence ahead of line-by-line scrutiny
The House of Commons Public Bill Committee has issued a call for written evidence on the Health Bill, with a reporting deadline of 16 July 2026. The bill's principal purpose is to abolish NHS England and transfer its functions to Integrated Care Boards and the Department of Health and Social Care, with a number of functions transferred directly to the secretary of state. Other key provisions include enabling a single patient record, implementing patient safety reforms recommended by the Dash review, abolishing Healthwatch, removing the requirement for NHS foundation trusts to have a council of governors, and conferring new powers on the secretary of state in relation to waiting times and patient choice.
Those with relevant expertise or a direct interest in the bill's provisions, including healthcare providers, patient organisations and those operating within the NHS supply chain, should consider responding.
MHRA advances regulatory framework for AI in healthcare
The MHRA's work to develop a regulatory framework for AI in healthcare is progressing across three related areas. The National Commission into the Regulation of AI in Healthcare has published a summary of findings from its call for evidence. Of 761 responses, the vast majority called for significant regulatory reform, with a proportionate, risk-based, lifecycle approach better suited to adaptive AI systems than the current medical devices framework. Key themes included continuous post-market surveillance, shared liability across manufacturers, providers and clinicians, and patient concerns about the use of NHS data by commercial entities. The commission's final recommendations to the MHRA and wider government are expected in the summer.
Those findings are consistent with the practical insights emerging from Phase 2 of the MHRA's AI Airlock regulatory sandbox, which ran from April 2025 to March 2026. Working with seven candidates across three challenge areas, the airlock found that human oversight cannot be treated as a fixed safety control as user scrutiny of AI outputs tends to diminish over time; that LLM-based products without active guardrails can exhibit functions beyond their intended purpose; and that performance thresholds must be grounded in clinical rather than merely statistical significance.
Phase 3 of the AI Airlock, funded by DHSC for three years from April 2026, will focus on delivering outputs mapped to specific MHRA actions and policy priorities shaped by the Commission's recommendations.
Alongside this, the MHRA has announced a new regulatory sandbox to test how AI can improve medicines safety assessment and development. Supported by the government's Regulatory Innovation Office, it will give companies and researchers a controlled environment to explore AI tools capable of predicting how medicines behave in the body, detecting adverse effects and improving understanding of how medicines work across underrepresented groups such as children, older people and people from diverse backgrounds. The initiative also forms part of a wider effort to drive alternatives to animal testing and support the government's AI for Science Mission, with the MHRA working with industry and academic partners from summer 2026 to shape how the sandbox operates.
EU
Commission publishes updated guidance on Joint Clinical Assessments
The European Commission and the Member State Coordination Group on Health Technology Assessment have published new and updated guidance on the EU Health Technology Assessment Regulation, clarifying publication, transparency and evidence requirements for Joint Clinical Assessment dossiers. The package includes a new FAQ on publication of JCA reports, updated methodological Q&A guidance on dossier preparation and evidence generation, and new guiding principles on handling commercially confidential information in JCA and joint scientific consultation procedures.
EUDAMED registration now mandatory for medical device market access in the EU
From 28 May 2026, the use of four modules of the European Database on Medical Devices is mandatory under the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. Any manufacturer or other party seeking to place a medical device on the EU market must be registered in EUDAMED and ensure that their registration and device information is complete and up to date. EUDAMED brings together information on economic operators, devices, certificates, clinical investigations, vigilance and market surveillance in a single digital platform, and is designed to enhance transparency, traceability and patient safety across the EU.
Manufacturers and other economic operators that have not yet completed their EUDAMED registration, or whose information is not up to date, risk losing access to the EU market.
EMA, Commission and HMA publish revised ACT EU workplan for 2026 to 2027
The EMA, European Commission and Heads of Medicines Agencies have adopted the fourth ACT EU workplan, covering 2026 and 2027. The workplan reflects feedback from the ACT EU multi-stakeholder advisory group and takes account of the proposed Biotech Act, which would amend the Clinical Trials Regulation, and the Clinical Research Investment Plan. Continuing priority areas include implementation of the Clinical Trials Regulation, maximising the impact of clinical trials through consolidated scientific and regulatory advice, and enabling multinational clinical trials during public health emergencies.
The revised workplan introduces new focus areas aligned with updated ACT EU objectives, including strengthening meaningful patient involvement throughout the clinical trial lifecycle, using clinical trial data to improve access and promote more inclusive trials covering underrepresented populations such as children and women, and supporting the timely submission of clinical trial results. It also introduces a new objective to enable innovation through responsible integration of AI, digitalisation, regulatory sandboxes and data use across the clinical trials lifecycle.
European Commission consults on AI in healthcare and pharmaceuticals
Following the publication of its Apply AI Strategy in October 2025, the European Commission has launched a consultation seeking views on the deployment of AI in healthcare and pharmaceuticals. The consultation covers the benefits, barriers and enablers of AI adoption in the sector, the type of EU-level support needed, and the conditions for scaling AI solutions across health systems. It is open to healthcare providers, pharmaceutical companies, AI solution providers, medical societies, patient organisations and industry associations. The findings will inform future policy actions to support the effective and trustworthy uptake of AI in both sectors. The consultation closes on 26 June.
Sustainable products
UK
HMRC consults on mandatory certification for recycled plastic packaging
HMRC has launched a consultation exploring the potential introduction of a mandatory certification requirement for UK manufacturers and importers of plastic packaging containing mechanically recycled plastic, and possible changes to the evidential requirements for claiming an exemption from Plastic Packaging Tax where packaging contains at least 30% recycled plastic.
The objectives of the proposal are to mitigate the risk of fraudulent or erroneous recycled content claims, standardise evidential requirements and strengthen compliance activity. Industry concerns have been raised about the validity of some recycled plastic claims, particularly for imported packaging, with UK recyclers and trade bodies calling for third-party certification to improve transparency and fairness.
If introduced, mandatory certification would operate via independent third-party schemes meeting minimum requirements to be set out in future legislation, with the government not proposing to prescribe a single scheme.
The consultation seeks views on the prevalence of fraud, the impacts on businesses across the plastics supply chain, how the requirement should operate in practice and potential implementation timings. It runs until 10 August 2026.
Government confirms plans to introduce mandatory deforestation due diligence for GB supply chains
See ESG section.
EU
EU Packaging and Packaging Waste Regulation: first compliance deadlines in August 2026
The first wave of requirements under the EU Packaging and Packaging Waste Regulation take effect from 12 August 2026, applying to any business that places or distributes packaging on the EU market, regardless of material. From that date, manufacturers must carry out conformity assessments and draw up a Declaration of Conformity for each type of packaging placed on the EU market, food contact packaging containing PFAS (per- and polyfluoroalkyl substances) above specified thresholds will be banned, and producers placing packaging on the market in a Member State where they are not established must appoint an authorised representative in that Member State.
Further requirements follow over the coming years and into the next decade, including reusable container systems for the hospitality sector, harmonised labelling, recyclability standards and single-use plastic bans. With key implementing acts still to come, businesses cannot afford to wait for regulatory clarity before acting. See this Insight for a detailed breakdown of all obligations and deadlines.
ESPR ban on destruction of unsold clothing and footwear comes into effect next month
The ban on large companies destroying unsold apparel, clothing accessories and footwear under article 25 of the Ecodesign for Sustainable Products Regulation (ESPR) takes effect on 19 July 2026, with medium-sized enterprises required to comply from 19 July 2030. With less than a month to go, businesses in scope should be reviewing their inventory management and any existing destruction arrangements to ensure they are ready to comply.
The ban is subject to a limited set of confirmed exceptions, including where products are dangerous, unfit for purpose, in breach of intellectual property rights, or where a genuine effort to donate them has proved unsuccessful. Any business relying on an exception must retain supporting documentation for five years.
While the destruction ban currently applies only to clothing and footwear, the ESPR disclosure obligations are broader: they cover all unsold consumer goods placed on the EU market. Businesses should already be collecting the relevant data, since the first disclosure must cover goods discarded during the first full financial year after the ESPR entered into force on 18 July 2024.
Major food and beverage companies lobby for delay to EU packaging regulation
A leaked letter signed by executives from major food and beverage companies has called on EU institutions to delay implementation of parts of the Packaging and Packaging Waste Regulation and reopen several core provisions ahead of the 12 August 2026 application date. The signatories cite unresolved legal and technical uncertainty around PFAS testing methods, reuse targets and single-use plastics restrictions, noting that no harmonised or legally binding EU-level methodology for PFAS testing currently exists to demonstrate conformity as required by the regulation.
The move has drawn strong opposition from over 160 environmental and consumer organisations, who have described it as an attempt to weaken agreed rules and warned that any delay would penalise those who have already invested in compliance. Businesses should continue to prepare for the August application date until any potential delay is announced.
EU's revised Waste Shipment Regulation enters into force alongside new digital tracking platform
The EU's revised Waste Shipment Regulation's (Regulation 2024/1157) main provisions entered into application on 21 May 2026, alongside the launch of the Digital Waste Shipment System (DIWASS).
All shipments of hazardous waste, mixed municipal waste, waste destined for disposal and contaminated waste are now subject to the prior informed consent procedure, which must be processed digitally through DIWASS. Operators moving green-listed non-hazardous waste destined for recovery may continue to use the existing paper procedure until 31 December 2026. The regulation also introduces stricter rules on plastic waste exports, with exports to non-OECD countries to be banned from 21 November 2026.
Businesses involved in cross-border waste movements need to ensure they are registered on DIWASS and familiar with the new digital procedures ahead of the end of the paper-based transition period.
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Regulatory law affects all businesses.
Osborne Clarke’s updated Regulatory Outlook provides you with high level summaries of important forthcoming regulatory developments to help in-house lawyers, compliance professionals and directors navigate the fast-moving business compliance landscape in the UK.
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