Products | UK Regulatory Outlook May 2026

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UK 

Windsor Framework Specialised Committee meets to take stock of implementation progress 

The Specialised Committee on the Implementation of the Windsor Framework met in Brussels on 7 May 2026, co-chaired by officials from the European Commission and the UK government.  

The co-chairs welcomed progress in a number of areas, including the satisfactory functioning of sanitary and phytosanitary (SPS) inspection facilities, individual labelling requirements, the finalisation of work to grant EU representatives access to all relevant UK IT systems, and technical flexibilities in the functioning of the Duty Reimbursement Scheme for Northern Ireland operators.  

However, they noted that work remains to be done on full certificate compliance, box-level labelling, customs arrangements for business-to-consumer parcels and ensuring that flexibilities are applied for compliant goods only. The co-chairs also confirmed the conclusion of their work on the implications of the Artificial Intelligence and Cyber Resilience Acts for the Windsor Framework, and noted that they will report to the Joint Committee co-chairs ahead of the next Joint Committee meeting.  

Businesses moving goods between Great Britain and Northern Ireland should continue to monitor implementation developments, particularly in the SPS and customs areas. 

Cyber Resilience Act and the Windsor Framework 

The EU has adopted a Council Decision setting out its position that the majority of the Cyber Resilience Act (CRA) should be added to Annex 2 of the Windsor Framework, which would make it applicable in Northern Ireland.  

The CRA sets minimum cybersecurity requirements for products with digital elements, placing obligations on manufacturers, importers and distributors, and categorises products by risk level, with standard products requiring self-assessment and higher-risk products requiring third-party conformity assessment. However, any addition to the framework can only take effect following a joint decision at the Withdrawal Agreement Joint Committee, and any agreement on the UK's part would require an applicability motion passed with cross-community consent by the Northern Ireland Assembly.  

The UK has requested an exchange of views with the EU to better understand the implications before any decision is taken; that exchange is ongoing. Manufacturers or suppliers of products with digital elements going into or through Northern Ireland should monitor developments closely, as the outcome will determine whether the substantive requirements of the CRA apply in Northern Ireland alongside the rest of the EU. 

Tobacco and Vapes Bill receives Royal Assent 

See advertising and marketing section. 

Life sciences and healthcare 

UK 

MHRA opens consultation on redefining gene therapy medicinal products 

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a UK-wide consultation on proposed changes to the legal definition of gene therapy medicinal products (GTMPs) in the UK. The proposed changes aim to ensure that regulation keeps pace with advances in gene therapy, synthetic biology and gene editing technologies since the current definitions were established over a decade ago.  

The consultation seeks views on five key proposals: removing the requirement for gene therapies to be biological in origin; clarifying when synthetic or recombinant nucleic acids bring a product into scope; ensuring products involving sequence-specific genome editing are clearly regulated as GTMPs regardless of substance type; maintaining the exclusion of vaccines against infectious diseases from GTMP definitions; and updating the Human Medicines Regulations 2012 to support the revised definitions.  

The MHRA has confirmed that the updated definition will not alter the approval process for gene therapies, the regulatory classification of already-licensed products, or existing safety, quality or efficacy standards. The consultation closes on 22 June 2026. 

MHRA publishes long-awaited draft medical devices regulations for pre-market requirements 

The MHRA and the Department of Health and Social Care have published the draft Medical Devices (Amendment) Regulations 2026 on the World Trade Organization notification portal, setting out proposed new pre-market requirements for placing medical devices and in vitro diagnostics (IVDs) on the GB market.  

The draft regulations introduce eight principal changes, including an international reliance pathway based on approvals from comparable overseas regulators in Australia, Canada and the US (notably not the EU), revised risk-proportionate classification rules for devices and IVDs, mandatory use of Unique Device Identifiers, and expanded use of electronic instructions for use.  

For the first time, UK medical device legislation will include specific provisions on advertising and promotion, covering misleading or unsubstantiated claims. Transitional provisions apply, with three-year periods for legacy general medical devices and five years for IVDs.  

The regulations are expected to be adopted in December 2026 and to enter into force in June 2027. Businesses should note that the MHRA has launched a parallel stakeholder impact survey, open until 19 June 2026, and that the deadline for WTO comments is 7 July 2026. Manufacturers, approved bodies and importers operating in the GB market should review the draft and consider responding. 

HRA implements updated clinical trials regulations with new operational guidance 

The Health Research Authority has introduced comprehensive updates to clinical trials regulations, effective 28 April 2026, applying to clinical trials of investigational medicinal products (CTIMPs) and including associated policy changes for non-CTIMP studies, developed in collaboration with health departments across all four nations of the UK. Accompanying operational guidance has been published covering: 

• a revised suite of model agreements for NHS and health and social care organisations, covering both commercial and non-commercial arrangements; 
• simplified arrangements for seeking and documenting informed consent in qualifying clinical trials; 
• a new modification tool replacing the previous amendment tool, introducing four distinct modification categories, mandatory for CTIMPs from 28 April 2026 and for non-CTIMP studies from 30 May 2026; 
• an updated UK Research Ethics Committee Policy Document reflecting changes in membership, terminology, timelines and REC decisions; and 
• a round-up of further HRA operational changes accompanying the new regulations. 

New studies submitted via the Integrated Research Application System (IRAS) from 28 April 2026 must use the updated model agreements. The current modification tool is an interim solution while the HRA develops a new digital service, Plan and Manage Health and Care Research, which will eventually replace multiple legacy systems. 

EU  

EU reaches provisional deal on Critical Medicines Act 

European Parliament and Council negotiators have reached a provisional deal on the Critical Medicines Act, which aims to reduce EU dependency on non-EU countries for essential medicines, including antibiotics, insulin, vaccines and medicines for chronic and rare diseases.  

The Act establishes a framework for strategic industrial projects in the EU to create, modernise and increase manufacturing capacity, with companies benefiting from national or EU financial support required to prioritise supply to the EU market. Contracting authorities will be required to apply procurement requirements that support the diversification of supply sources for critical medicines, with flexible options available to incentivise EU manufacturing, including rewarding suppliers proportionally to the share of medicinal products manufactured in the EU. The agreement also provides for voluntary collaborative procurement, with the Commission required to initiate a procurement procedure on behalf of Member States when five or more countries request it.  

The provisional agreement must be approved by both Parliament and Council before entering into force. Pharmaceutical manufacturers and suppliers operating in or supplying to the EU market should monitor the Act's progress closely, particularly those whose supply chains remain heavily dependent on non-EU manufacturing. 

Sustainable products 

UK 

Parliamentary committee calls for faster action on PFAS regulation 

The House of Commons Environmental Audit Committee has published a report criticising the government's February 2026 PFAS Action Plan as lacking decisive action and warning that UK REACH has fallen behind the EU in restricting per- and poly-fluoroalkyl substances, commonly known as "forever chemicals" due to their persistence in the environment.  

The committee has recommended that the government introduce phased restrictions on non-essential PFAS uses from 2027 under UK REACH, taking a group-based approach to ensure that banned substances are not simply replaced with harmful alternatives, and that it require businesses to obtain approval before introducing any new PFAS substance. On remediation, the committee recommends applying the polluter pays principle, consulting by March 2027 on establishing a national fund for PFAS remediation, and investing in technology for safe destruction of PFAS. The report also calls for limits on PFAS in food, mandatory supply chain disclosures and use of existing EU-UK dialogue mechanisms to avoid unnecessary regulatory divergence from EU REACH.  

Manufacturers and suppliers of products containing PFAS should monitor the government's response and assess their exposure across supply chains in anticipation of potential tightening restrictions. 

Regulations amend GB chemicals regimes for biocides, prior informed consent and classification, labelling and packaging 

The Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026, made on 30 April 2026, came into force on 21 May 2026. They amend the GB chemicals regimes for biocides, prior informed consent (PIC) and classification, labelling and packaging (CLP), correcting issues that could not be addressed at the time of the UK's departure from the EU due to the nature of the legal powers in the European Union (Withdrawal) Act 2018. See the explanatory memorandum. 

Northern Ireland consults on new Waste Prevention Programme 

The Department of Agriculture, Environment and Rural Affairs has launched a consultation on its draft 2026 Waste Prevention Programme for Northern Ireland, setting out 21 actions to reduce waste at source and support a transition to a circular economy.  

Measures include implementation of extended producer responsibility for packaging, eco-design and eco-labelling initiatives, a deposit return scheme for single-use drinks containers due to go live in October 2027, waste electrical and electronic equipment (WEEE) reform, continued administration of the carrier bag levy and food waste prevention initiatives delivered in partnership with the non-governmental organisation WRAP.  

The programme also proposes support for reuse and repair through community-based initiatives and an annual Reuse and Repair Week. Businesses operating in Northern Ireland across manufacturing, retail, food and drink and the wider supply chain should review the proposed actions and consider responding to the consultation before it closes on 10 July 2026. 

EU 

European Commission confirms it will not reform REACH at this stage 

The European Commission has confirmed that it will not review or reform REACH, the EU chemicals regime, at this point, with Commissioner Roswall citing the need for certainty and predictability in a speech to the European Parliament's Committee for Environment, Climate and Food Safety on 27 April 2026.  

The Commission has indicated it will nonetheless continue to explore ways of simplifying and modernising REACH, including through comitology, and will bring forward initiatives to improve enforcement against non-EU compliant products and substances at borders and through more effective market surveillance. Those operating under EU REACH should note that while a broader reform has been taken off the table for now, enforcement activity is expected to intensify, and ongoing work on PFAS restrictions through ECHA's scientific committees continues. 

EU publishes rules on permitted exceptions to ban on destruction of unsold consumer goods 

New rules setting out the limited circumstances in which businesses may destroy unsold consumer products have been published in the Official Journal. Commission Delegated Regulation (EU) 2026/296, published on 22 April 2026, sets out the permitted exceptions to the prohibition under Article 25 of the Ecodesign Regulation 2024. The ban currently applies to apparel, clothing accessories and footwear, taking effect from 19 July 2026 for large enterprises and 19 July 2030 for medium-sized enterprises. 

Destruction is permitted where a product is dangerous, unfit for purpose due to non-compliance with EU law or an unrepairable defect, in breach of intellectual property rights, or unsuitable for reuse or remanufacturing. It is also permitted where no waste treatment operator can be found, or where the product is not accepted as a donation by a social economy entity or cannot be redistributed by one. 

Documentation evidencing the basis for relying on any of these derogations must be maintained for five years and made available to competent authorities on request. 

European Commission consults on digital product passport registry 

On 27 April 2026, the European Commission published a consultation on its draft implementing regulation concerning the operation of the digital product passport registry under the Ecodesign Regulation 2024. Digital product passports are designed to provide easy access to digital information relating to a product's sustainability, circularity and legal compliance, and the consultation closes on 27 May 2026. 

The draft implementing regulation would require verified economic operators and other verified value-chain actors to register product passports through a secure interface or application programming interface (API), with automatic checks on mandatory data, granularity and qualified electronic signatures or seals. The registry would apply across all products subject to the regulation (including batteries, toys, detergents and construction materials) and would incorporate a semantic repository, log system and proof-of-registration function. 

Businesses that operate in the EU should review the consultation and consider whether they wish to submit feedback.