Products | UK Regulatory Outlook October 2026

Jump to: Life sciences and healthcare products | Sustainable products

General/digital products

UK

Law Commission launches consultation on product liability reform

The Law Commission has proposed a wide-ranging overhaul of the UK's strict product liability regime under the Consumer Protection Act 1987. Much of the proposed reform closely mirrors the EU's new Product Liability Directive, which must be implemented by member states by 9 December.

The Law Commission's proposal would align the UK regime with the EU's extended definition of "product", bringing software and artificial intelligence (AI) into scope. It would also align with the EU on a presumption of defect with risk-sharing for claimants facing exceptional evidential difficulty, and on extending the long-stop period to 25 years for latent personal injury claims.

While the EU directive does not expressly treat the design of social media and similar platforms as a product in its own right, the Law Commission's proposal would. Algorithms, infinite scroll, autoplay and personalised notifications would all fall within strict liability under the UK proposal, an approach the Commission draws explicitly from US litigation over social media design.

The EU directive also covers "related services" that a product depends on to function, such as a smart fridge's temperature-control service, treating providers of those services as potentially liable component manufacturers. The Law Commission does not adopt this concept, so these services stay out of scope under its proposal.

If the Law Commission's proposals go ahead as drafted, meeting the EU's new requirements would not automatically satisfy the UK position, or vice versa. Businesses involved in producing or distributing products in the UK should review the proposals and consider responding before the consultation closes on 14 January 2027.

Private member's bill would introduce mandatory safety standards for e-scooters sold in Great Britain

A new bill in the House of Lords would require e-scooters sold in Great Britain to meet mandatory safety standards before they can be sold. It would require the secretary of state to set requirements covering maximum speed, power output, braking systems, lighting and construction. Manufacturing, importing, selling or supplying an e-scooter that falls short of those requirements would be an offence.

The bill would also ban the sale of kits or other equipment designed to modify a compliant e-scooter so it falls out of compliance and make it an offence to market an e-scooter in a way that could lead a buyer to think it can lawfully be used somewhere that its use is in fact unlawful. Compliant e-scooters could still be sold for use on private land with the landowner's permission. Trading standards officers and the police would gain powers to seize non-compliant machines, with penalties on conviction capped at level three on the standard scale, currently £1,000.

The bill's progress is worth watching for retailers, importers and manufacturers supplying e-scooters to the UK market. If it progresses into law, it would come into force six months after Royal Assent, with the detailed technical requirements left to regulations rather than the bill itself.

EU

European Parliament adopts chemicals omnibus changes

The European Parliament has adopted changes to cosmetics, chemicals labelling and fertiliser rules under the EU’s “Omnibus VI” simplification package. The text, informally agreed with Council of the EU negotiators, still requires formal Council endorsement.

The changes would introduce transition periods for cosmetics containing prohibited carcinogenic, mutagenic or reprotoxic substances, shorter than those proposed by the Commission. Revised chemicals rules would allow greater use of digital labelling and ease advertising requirements, while retaining minimum label legibility standards. Fertiliser rules would simplify REACH (registration, evaluation, authorisation and restriction of chemicals) regulation requirements, while retaining an obligation for substances classified as particularly harmful.

Following Council endorsement, the legislation would enter into force 20 days after publication in the EU Official Journal. Most cosmetics provisions would apply from that date, with revised labelling rules generally applying after 18 months. Affected businesses should review product phase-out and labelling plans against the final requirements and transition periods.

European Commission proposes faster route to harmonised standards, with free public access

The European Commission has proposed replacing the Standardisation Regulation that has governed how EU harmonised standards are developed since 2012. Businesses rely on these standards to show their products comply with EU law, from construction materials to batteries and cybersecurity products, and speed is the headline figure in the Commission's proposal. It estimates the changes would cut the average time to develop a new standard from six years to four.

The proposal sets clearer deadlines for standards the Commission requests and allows interim deliverables, so products can reach the market before a full standard is finished. It also lets other standards bodies help with urgent or specialised technical work, and allows the Commission to rely more on external technical specifications where no harmonised standard yet exists.

Many businesses currently pay to access the harmonised standards they rely on for compliance. Following recent rulings from the Court of Justice of the EU, the proposal would write free public access into law, through dedicated repositories for standards developed to support EU legislation.

The proposal must still be agreed by the European Parliament and the Council of the EU in identical form before it takes effect and anyone relying on EU harmonised standards for compliance should watch this proposal as it moves through the legislative process.

Life sciences and healthcare

UK

MHRA publishes 2030 Strategy for AI-enabled, patient-centred medicines regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, setting out commitments across operational performance, patient involvement, enforcement, innovation and international collaboration. Two of these commitments will matter most to sponsors bringing products through UK regulatory approval: faster timelines, and new AI-specific regulation.

The MHRA will introduce a new higher-value scientific advice service that cuts the standard response time from 90 to 45 days. It will also halve the initial assessment target for qualifying phase 1 clinical trials to 14 days, and aims to make faster decisions on generic and biosimilar products.

On AI, the MHRA will develop an AI-enabled clinical trial protocol checker, publish an AI medicines development action plan in 2027, and create a new regulatory framework for AI as a medical device. It will also establish a dedicated Centre for AI and Digital Health to clarify regulatory expectations for developers of digital and AI-driven products.

The strategy also commits to expanding reliance and recognition routes with trusted regulators. This includes closer collaboration with the US FDA, continued recognition of CE-marked devices, and chairing the Access Consortium of Australia, Canada, Singapore, Switzerland and the UK. Sponsors with products already moving through other national approval routes should watch for faster UK recognition of that existing approval.

Other commitments include a shift toward non-animal testing methods such as organoids, a voucher scheme to reduce regulatory barriers for start-ups, and a more flexible framework for rare disease therapies.

Patient Safety Commissioner sets out priorities for second term

The Patient Safety Commissioner for England has published her strategy for 2026 to 2028, covering the second term of a role created to give patients an independent voice in safety matters across the healthcare system. Two commitments affect life sciences and medical device businesses directly.

The strategy commits to improving monitoring of medical devices so that emerging risks are identified earlier, alongside stronger national standards and governance for remote prescribing and clearer digital medicines information. It also commits to increasing transparency of payments made by medical device manufacturers to the healthcare sector. On AI, the commissioner intends to shape how AI is regulated in healthcare, with patient involvement built in from the start rather than added once systems are already in use.

None of these commitments are binding, but businesses in these sectors should expect the commissioner to press regulators and government on each point over the next two years.

MHRA opens call for evidence on AI in medicines development and safety

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Regulatory Innovation Office have opened a call for evidence on AI in medicines development and safety. It asks how organisations are applying AI, or plan to, in this area. Life sciences and biotechnology businesses working on AI tools for toxicology, preclinical research or clinical testing have reason to respond, since this call will shape how those tools are regulated.

The MHRA wants to understand current and planned use of AI-based approaches, along with the barriers organisations face around model development, validation, data access and data sharing. Businesses do not need to be using AI for medicines safety today to respond, since the call also covers future plans and gaps that AI could fill.

The responses will feed into the "Beyond ADMET: AI for Medicines Safety" regulatory sandbox, announced in June. The sandbox will let developers test and refine AI tools for assessing how medicines are absorbed, distributed, broken down and excreted in the body, and their toxicity. The call for evidence closes on 22 December.

Government accepts all 44 recommendations of National AI in Healthcare Commission

The government has accepted in full all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, published in September, and has set out how they will be delivered. The reforms move away from one-off approval of AI-enabled medical devices towards monitoring their performance throughout their working life.

The MHRA will issue draft guidance by December on managing changes to AI-enabled devices as they evolve. A consultation on how to qualify and classify these devices will follow next year. The government also plans to explore staged authorisation pathways that would let promising AI tools be used in the NHS earlier, under close supervision, while further evidence is gathered. A full implementation roadmap covering all 44 recommendations is due by spring 2027.

Alongside the government's response, the MHRA has opened applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices. This phase focuses on post-market surveillance and lifecycle monitoring, the principle at the centre of the wider reforms. The first wave of participants will be selected in November 2026.

Manufacturers of AI-enabled medical devices can expect future approval to depend on ongoing performance monitoring after a product reaches market, not just a one-time assessment. AI Airlock also offers a route to earlier, supervised NHS access for products still gathering evidence.

Government confirms indefinite recognition of CE marked medical devices

Following a targeted consultation that closed in April, the government has confirmed that CE marked medical devices and in vitro diagnostic devices can continue to be placed on the Great British market. No separate UK approval is needed, and the recognition is indefinite rather than time-limited. More than 90% of medical devices currently registered in Great Britain carry a CE mark, so this avoids manufacturers needing to seek duplicate approval for products already approved for the EU market.

CE marking therefore remains an indefinite parallel route to market alongside UK Conformity Assessed) (UKCA) marking, which stays in place as the UK's own approval route. The requirements devices must meet to carry a UKCA mark are being updated through a forthcoming pre-market statutory instrument. Separately, the government intends to use primary legislation to create powers for a future medical device licensing regime. This is aimed at technologies such as software and AI-enabled devices that the current framework is less well suited to.

Manufacturers and distributors placing CE marked devices on the Great British market do not need to apply for UKCA marking or any other UK-specific approval for those products. They can rely on this position when planning future market access.

EU

Council adopts EU pharma package reforming data protection and market exclusivity rules

The Council of the EU has adopted the "pharma package", a far-reaching reform of EU pharmaceutical legislation intended to improve patients' access to medicines, cut regulatory burdens and strengthen security of supply.

New medicines will receive an eight-year data protection period plus one year of market protection, extendable by one further year for innovative medicines meeting specified clinical trial criteria, or by a second year for unmet medical need; total combined protection is capped at eleven years (twelve with a transferable exclusivity voucher). Orphan medicinal products will receive nine years of exclusivity, rising to eleven for "breakthrough" treatments for previously unauthorised conditions.

Member states will gain power to require sufficient supply of protected medicines to meet patient needs, with safeguards against parallel trade, and the "Bolar exemption" is extended to let generic manufacturers prepare for market entry, including tender applications, before IP rights expire. A new transferable exclusivity voucher will reward development of priority antibiotics, subject to a "blockbuster clause" barring use on products with annual sales above €490 million.

The regulation and directive must still be adopted by the European Parliament before entering into force.

EU clinical trial applications advice pilot made permanent from January 2027

The Accelerating Clinical Trials in the EU (ACT EU) advice pilot will become a permanent initiative from January 2027. It gives sponsors technical and regulatory support before they submit a clinical trial application through the Clinical Trials Information System. The advice procedure is coordinated by the Heads of Medicines Agencies through its Clinical Trials Coordination Group (CTCG).

Before the pilot launched in 2024, sponsors could only get this kind of support at national level, from the single member state evaluating their application. The pilot provides consolidated feedback from all member states concerned on specific pre-submission topics, before a sponsor commits to a formal submission.

ACT EU will keep managing applications already submitted under the pilot until the end of the year. A final report on lessons learned from around 30 pilot applications is due before then. Updated guidance and templates for sponsors will follow on the CTCG website in January 2027.

Sustainable products

UK

Environment Agency relaxes 2026 packaging recycling obligations for plastic, steel and wood

The Environment Agency has published Regulatory Position Statement (RPS) 383. Under it, the agency will not normally take enforcement action against large producers and compliance schemes that meet reduced recycling obligations for the current compliance year. The reduced thresholds are 83% of the statutory obligation for plastic, 92% for steel and 90% for wood. Producers must still meet their full statutory obligation for every other packaging material.

The RPS does not change the underlying legal requirements to register as a large producer, report packaging data, or comply with recycling obligations under the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024. Producers relying on it must keep records for five years, and non-compliance with the statutory recycling obligations will still be recorded on their Certificate of Compliance, even where they meet the RPS conditions.

The Environment Agency has confirmed it will withdraw RPS 383 on 31 January 2027, though withdrawal or amendment may come earlier. Producers that cannot meet even the reduced thresholds are advised to inform the Environment Agency immediately.

HMRC publishes guidance on mass balance approach for chemically recycled plastic in Plastic Packaging Tax

HMRC has published guidance, and a technical consultation on draft regulations on using a mass balance approach to account for chemically recycled plastic in Plastic Packaging Tax (PPT) returns, alongside separate guidance on the minimum certification requirements for using that approach.

From 1 April 2027, businesses that manufacture packaging components in the UK using chemically recycled plastic, or import finished components made this way, will need to use a mass balance approach for that content to count for PPT purposes. Otherwise, it will be treated as virgin plastic. The approach is only available where the recycling process changes the chemical structure of the plastic waste. Every business in the supply chain must hold certification from a scheme meeting HMRC's minimum requirements, supported by attribution declarations and records kept for six years. HMRC says it will publish more detailed guidance, including on penalties, in early 2027.

The draft Plastic Packaging Tax (Chemical Recycling Certification Schemes) Regulations 2027, now out for technical consultation, set out the conditions businesses must meet to use a mass balance approach, covering attribution methodology, certification, auditing, monitoring and record keeping, alongside a draft reference document setting out the methodology for applying dual-use factors to output products.

PPT came into force on 1 April 2022. It applies to plastic packaging components manufactured in or imported into the UK that contain less than 30% recycled plastic by weight, at a rate of £200 per tonne. Manufacturers and importers that meet the relevant threshold must register with HMRC and pay the tax. Other businesses in the supply chain must carry out due diligence to avoid being held jointly and severally liable for unpaid PPT.

Defra publishes guidance on issuing PRNs and PERNs under packaging EPR

Defra has published guidance on issuing packaging waste recycling notes (PRNs) and packaging waste export recycling notes (PERNs) under extended producer responsibility (EPR) for packaging. Large producers must obtain these notes to meet their recycling obligations, based on the tonnage of packaging they place on the UK market.

PRNs may only be issued by accredited reprocessors, and PERNs by accredited exporters, for eligible UK-derived packaging waste within the scope of their accreditation. Exporters may only issue a PERN once the waste has been received at an accredited overseas reprocessing site and the required supporting documentation is available.

The guidance also covers eligible and ineligible waste categories, issuance deadlines, use of the digital issuance service, record-keeping requirements, and permitted uses of the revenue they generate. If a note is issued incorrectly and accepted by the producer or compliance scheme, the issuer must get their agreement to cancel it and then apply to the relevant regulator. Reprocessors and exporters that fail to cooperate with correcting incorrect notes risk having their accreditation suspended or cancelled.

EU

European Commission consults on draft rules for battery passport access rights

The European Commission has published a draft implementing regulation setting out who can access information on repairing, remanufacturing, repurposing and recycling batteries, held within the digital battery passport. It is seeking feedback until 16 November. From February 2027, large batteries, including electric vehicle batteries and industrial batteries over 2 kWh, must carry a battery passport accessible via QR code, covering performance, sustainability and compliance information. Some of that information is intended to be public, while this category is restricted to those with a legitimate interest.

The draft regulation identifies repairers, remanufacturers, repurposers, recyclers, waste management operators carrying out treatment, and vocational training centres as having a legitimate interest. This covers information needed to assess a battery's condition and decide how to repair, reuse or recycle it. Purchasers of a battery, and third parties acting on their behalf, would also have access to information relevant to resale and sourcing replacement parts.

Businesses granted this access could generally download and use the information only for these specified purposes, and would not be permitted to share or publish it more widely. Limited exceptions are proposed for emergency services, poison centres, customs authorities and market surveillance authorities. Businesses operating in the battery supply chain, including repairers, recyclers and vehicle manufacturers, will be looking to review the draft rules and consider responding before the consultation closes.

European Parliament and Council diverge on EPR representative suspension for packaging and batteries

See ESG section.