Products | UK Regulatory Outlook October 2024

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General / digital products

UK

Regulatory Innovation Office

The UK government has launched the Regulatory Innovation Office (RIO) to streamline regulatory processes and support the swift market entry of innovative products and services. Initially focusing on engineering biology, AI and digital healthcare, connected and autonomous technology, and the space sector, the RIO aims to reduce regulatory barriers and enhance the UK's competitive edge in innovation. This initiative is part of a broader strategy to attract investment and improve regulatory collaboration and will affect businesses looking to place innovative products on the market. Read our Insight for more.

Call for evidence on common charger for electrical devices

The EU has adopted the "Common Charger Directive" which requires the use of USB-C based charges for mobiles phones and other portable electronic devices place on the EU market from December 2024. The Office for Product Safety and Standards (OPSS) is currently seeking views from manufacturers, importers, distributors and trade associations as to whether the UK should also adopt this initiative.

The OPSS recognises that manufacturers are likely to adopt a similar approach to the EU Common Charger Directive on a voluntary basis in order to avoid supply chain complexity and therefore expect it to become industry standard. As such, the government is looking for comments as to whether it is beneficial to implement this change by amending the Radio Equipment Regulations 2017 using the new powers given under the Product Regulation and Metrology Bill, which is currently making its way through Parliament.

The call for evidence closes on 2 December 2024.

Consultation launched on PAS 7055:2025 Button and coin batteries

BSI has published PAS 70552025 on button and coin batteries. This PAS specifies safety requirements for button and coin batteries up to 32 mm in diameter to mitigate the risk of ingestion and defines the safety requirements for manufacturers and producers. This PAS is also relevant for retailers and distributors of these products and can be downloaded for free. A four-week consultation on this is currently running and comments are to be made by 28 October 2024.

Businesses whose products contain button and coin batteries should review the PAS and decide whether they wish to submit any comments.

Product Regulation and Metrology Bill has second reading

On 8 October, the Product Regulation and Metrology Bill had its second reading in the House of Lords and was broadly welcomed by the House. However, a key theme coming from the debate is that the bill lacks detail and without seeing the draft statutory instruments which will provide this detail, there is little for the Lords to scrutinise. Many members called on the government to bring forward draft regulations, as well as the government's response to the product safety review consultation, before committee stage.

Certain lords also welcomed the bill addressing products being sold online, noting that there is a need for clear and enforceable duties on online marketplaces to ensure product safety. Lithium-ion batteries were also discussed by a number of lords noting the increasing safety risk and calling for third-party safety certification and better regulation.

Other points raised by lords included the need for clarity on interaction with devolved competencies and the Windsor Framework; concerns about the adequacy of resources for enforcement authorities; and the importance of consulting stakeholders and ensuring parliamentary oversight of secondary legislation.

The committee stage is scheduled for 4 November 2024.

The Delegated Powers and Regulatory Reform Committee published a report scrutinising the bill. The committee criticised the bill for being "skeleton legislation," meaning it lacks substantive detail and instead grants broad powers to ministers. Additionally, the committee highlighted that the bill does not require consultation or set criteria for the exercise of these powers, reducing transparency and accountability. The committee stated that this is a departure from existing regulatory practices that often include consultation requirements. These findings will be fed back to the House of Lords.

The bill has also been criticised by the Lords Select Committee on the Constitution, which reiterated the concerns over the bill being skeleton legislation and the broad scope of powers it gives ministers, which it says inhibits parliamentary scrutiny.

EU

Council formally adopt the new Product Liability Directive

On 10 October, the Council of the European Union adopted the new Product Liability Directive.

The new directive updates civil liability rules to reflect the digital and circular economy. Key elements include:

• Digital products: extending the definition of a "product" to include digital files and software - this includes software-as-a-service and AI.
• Circular economy: shifting liability when products are repaired by third parties outside the original manufacturer's control.
• Disclosure of evidence: easier access to evidence for consumers.
• Non-EU manufacturers: liability for damages from non-EU products.
• Burden of proof: potential to reverse the burden of proof under certain conditions.

The Act will be published in the Official Journal of the European Union in the coming weeks and will enter into force 20 days following its publication. Once in force, Member States of the EU have until two years to transpose the new directive into national law.

You can track the directive on our Digital Regulatory Timeline.

Council formally adopts Cyber Resilience Act

The Council of the EU adopted the Cyber Resilience Act on 10 October. This new horizontal regulation introduces stringent cybersecurity requirements for products with digital elements, such as connected home devices. Key elements include:

• EU-wide cybersecurity standards for hardware and software.
• CE marking to indicate compliance.
• Application to all connected products, with some exceptions.

The directive will be published in the Official Journal of the European Union in the coming weeks and will enter into force 20 days following its publication. Once in force, the full regulation will apply in around 36 months, with some provisions taking effect earlier.

You can track the regulation on our Digital Regulatory Timeline.

European Parliament approves Regulation on forced labour products

Please see Modern slavery.

Product sustainability

UK

Government to ban single-use vapes from 1 June 2025

The government has laid legislation which will ban the sale of single-use vapes from 1 June 2025. Businesses will have until this date to sell any remaining stock ahead of the ban coming into force. The government explains that this ban will not only protect the environment by reducing waste and pushing towards a circular economy, but also reduce appeal to young people. A single-use vape is one which is not refillable and/or rechargeable. The ban will be enforced by Trading Standards within each local area, using civil penalties.

The Scottish, Welsh and Northern Irish governments will also be introducing equivalent legislation, with the same implementation date of 1 June 2025, with Wales already confirming its intention to do so.

Draft EPR regulations laid before Parliament

The draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 have been laid before parliament. The regulations implement the extended producer responsibility (EPR) scheme for packaging waste. 

The key change from the previous draft of the regulations (see this earlier Regulatory Outlook) is that the provision on mandatory recyclability labelling has been removed. The government is delaying the implementation of this requirement as they want to see what the EU will do under the Packaging and Packaging Waste Regulation to ensure a consistent approach to minimise costs and complexity for businesses. They will introduce the recycling labelling requirements via amending regulations when ready to do so.

Design for Life Roadmap: Building a circular economy for medical technology

Please see the Life sciences and healthcare section.

EU

FAQs on Ecodesign for Sustainable Products Regulation

The European Commission has published FAQs on the Ecodesign for Sustainable Products Regulation (ESPR) which covers, among other things: scope of the regulation; interplay with others regulations, including the Packaging and Packaging Waste Regulation, the Right to Repair Directive, and the Corporate Sustainability Reporting Directive; questions around the Digital Product Passport (DPP), including a provisional timeline, noting they expect the first DPP provisions in mid-2027; details on the ecodesign forum, including who can join the forum which includes non-EU based parties; and preparation of the delegated acts and working pan.

This document will be helpful for businesses in understanding the ESPR and how it will affect them and their products.

FAQs on EU PFAS restriction

The European Environmental Bureau has published FAQs on the proposal restricting the use of PFAS presented to the European Chemicals Agency (ECHA) in February 2023. The aim of this document is to clarify misinterpreted information that has disseminated since the proposal was put forward. As a reminder, the ECHA is still yet to publish further information following its consultation on the proposal (see this earlier Regulatory Outlook for more). While they await this consultation response, businesses should use this FAQ document to remind themselves of the proposal on restricting PFAS and how it will affect them.

Commission restricts use of a sub-group of PFAS chemicals

The European Commission has adopted new measures under REACH to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA ‑related substances. These are sub-groups of PFAS.

The restriction will ban the sale and use of PFHxA in consumer textiles, such as rain jackets; food packaging, like pizza boxes; consumer mixtures such as waterproofing sprays; cosmetics; and in some firefighting foam applications. It does not affect other applications of PFHxA, for example in semiconductors, batteries or fuel cells for green hydrogen.

The announcement outlines that this restriction is distinct from the potential restriction on the entire PFAS group which the European Chemicals Agency (ECHA) is assessing following a 2023 proposal by five European governments.

From 10 October 2026 the restriction will apply to: textiles, leather, furs and hides in clothing and related accessories for the general public; footwear for the general public; paper and cardboard used as food contact materials; mixtures for the general public; cosmetic products. The concentration limits are 25 ppb for PFHxA and its salts, 1,000 ppb for PFHxA-related substances. This will then apply to textiles, leather, furs, and hides (other than those in clothing and related accessories for the general public) from 10 October 2027.

From 10 April 2026 restrictions will come into place for firefighting foams and concentrates for training and testing (except functional testing with contained releases) and firefighting foams and concentrates for public fire services (with exceptions for industrial fires at establishments covered by Directive 2012/18/EU). The concentration limits are 25 ppb for PFHxA and its salts, 1,000 ppb for PFHxA-related substances. From 10 October 2029 restrictions for firefighting foams and concentrates for civil aviation (including civilian airports) will come into effect.

Life sciences and healthcare

UK

MHRA launches 2024/25 business plan focusing on harnessing new technology

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2024/25 business plan which has a particular focus on innovation and harnessing medical technology. Within the plan, the MHRA sets out its four priorities for the coming year which are to:

• Maintain public trust through transparency and proactive communication, including working to address health inequalities.
• Enable healthcare access to safe and effective medical products.
• Deliver scientific and regulatory excellence through strategic partnerships.
• Become an agency where people flourish alongside a responsive customer service culture.

The plan also provides initiatives that the MHRA will be introducing, which includes, among others:

• Boost how the it handles enquiries by end Q3 (which could give businesses some extra practical support, particularly for innovative products).
• Review the International Recognition Procedure by Q3 to make sure it is working as intended (which could improve routes to market in the UK for pharmaceutical manufacturers).
• Deliver the 2024/25 milestones for medical devices international recognition (which could speed up authorisation for medical devices and health-tech already approved in other jurisdictions).
• Prepare legislation to deliver a new UK clinical trials regulatory framework by end Q4 (which would finally see action following the O'Shaughnessy Review of 2023 into clinical trials).
• Keep to the road map on delivering new UK medical devices regulations in 2025.

The MHRA's focus on innovation is expected to be facilitated by the creation of the new RIO - which will initially be focusing on digital healthcare - and so we expect to see further developments in this space and it will be interesting to see how the RIO supports the MHRA in delivering its priorities.

UK government invest £118 million investment into new research hubs for medical technology

The government has this month announced a £118 million investment into five new research and partnership hubs to develop new medical technologies, such as AI models that can detect cancer. This investment, alongside the RIO, underlines the government's commitment to advancing technology in the healthcare sector.

MHRA's AI Airlock regulatory sandbox for AIaMD now open

The AI Airlock is a regulatory sandbox for AI as a medical device (AIaMD) (previously covered here). The MHRA is now calling for applications from manufacturers and developers of AI medical devices to join the regulatory sandbox. The project is intended to help the MHRA identify and address challenges in regulating AI medical devices to help cut down the time to bring AI medical devices safely to market. Businesses that manufacture and develop AIaMD  should decide whether they wish to apply to the sandbox.

Post-market surveillance regulations laid in Parliament

The draft Post-Market Surveillance (PMS) amending regulations were laid in Parliament on 22 October 2024. These draft regulations amend the Medical Devices Regulations 2002 to insert new post-market surveillance requirements to bring the UK regulatory framework closer in line with international best practice.

The key changes include:

• PMS system: manufacturers are required to has a PMS system for each device, proportionate to the risk posed by the device.
• Investigation and reporting of serious incidents: enhanced serious incident reporting obligations for manufacturers requiring them to report any serious incidents involving their devices to the secretary of state and investigate serious incidents and submit a final report to the secretary of state.
• Field safety corrective actions (FSCA) and field safety notices (FSN): clearer obligations on manufacturers to consider conducting a FSCA to prevent or reduce the risk of a further serious incident. Accompanied by detailed requirements relating to FSN to better target patients and users at risk.
• Periodic safety update reports: more stringent requirements for manufacturers to conduct periodic reviews of their PMS data in a bid to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.

The draft PMS SI will be debated in Parliament and is expected to come into force in the summer of 2025 following a six-month implementation period. Manufacturers should start to familiarise themselves with the new regulations to understand the changes and what their new obligations will be.

New regulations laid for medicines manufactured at the ‘point of care’ and modular manufacturing

The draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 have been laid to amend the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004 to provide a new regulatory framework for medicines manufactured at the "point of care" (POC), and modular manufacturing (MM), where products are manufactured in modular, relocatable units.

There is currently no legislative provisions for POC and MM of medicines and the current regulations are designed for medicines produced at a few sites and distributed globally, which is not suitable for products manufactured at POC and MM. These products often have short shelf-lives or are highly personalised, necessitating manufacturing at or near the point of care.

Therefore the amending regulations will allow for medicines to be manufactured and supplied at the POC and support MM. They come into force six months after the date they are made. Detailed guidance on the new framework will be published by the MHRA in advance of the regulations coming into force.

Unlocking the potential of UK healthtech

The Office for Life Sciences commissioned KPMG to identify and systematically map out manufacturing and research and development activity across the UK healthtech sector. The report, titled "Unlocking the potential of UK HealthTech", has been published and highlights the significant opportunities for the UK to become a global leader in healthtech innovation. The report found, among other things, that UK healthtech businesses are committed to manufacturing in the UK, but found that the current regulatory landscape is a barrier to innovation, affecting R&D and manufacturing. Other challenges include that NHS procurement is focused on cost optimisation and as such procurement policies suppress innovation adoption.  

The report sets out a number of recommendations including streamlining regulation and embracing value-based procurement so the NHS prioritises long-term innovation and healthcare benefits over cost considerations.

With the life sciences sector being one of the government's growth-driving sectors, as set out in its recently published Industrial Strategy, we anticipate that these findings will assist the government in driving reform within the sector.

Changes proposed to the statutory scheme to control the cost of branded health service medicines

The government has published its consultation response on proposals to amend the statutory scheme to control the cost of branded health service medicines, alongside an impact assessment. This scheme sits alongside the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG), that control the costs of branded medicines to the NHS. Following the responses received, the following changes will be implemented:

• Adjusting baseline sales in the statutory scheme by £150 million in 2025, £330 million in 2026, and £380 million in 2027.
• Implementing a differentiated approach to setting payment percentages for newer and older medicines.
• Setting the headline payment percentage for newer medicines at 15.5% in 2025, 17.9% in 2026, and 20.1% in 2027.
• Establishing the basic payment percentage for older medicines at 10.6% in 2025, 11% in 2026, and 10.9% in 2027, with a top-up payment percentage for older medicines ranging from 1% to 25%, if applicable, based on the level of observed price erosion from a reference price.
• Introducing exemptions to the top-up payment percentage for relevant plasma-derived medicinal products and company sales totalling less than £1.5 million of a health service medicine in a specific virtual therapeutic moiety each year.
• Raising the exemption threshold from scheme payments for small companies, from sales below £5 million to sales of less than £6 million.

Design for Life roadmap: building a circular economy for medical technology

The Department of Health and Social Care has launched a Design for Life roadmap to reduce the amount of single-use medtech used in the NHS and reduce reliance on products imported from foreign countries. Ensuring circularity in these products will mean looking at designing, procuring and the process of medical products that allows them to be re-used, re-manufactured or recycled. This roadmap feeds into the government's wider aim of moving towards a circular economy.

The roadmap is divided into six problem statements which are to be addressed by 30 actions to deliver a 2045 vision. The six problem statements are as follows, with some of the actions highlighted as well:

Leadership and alignment: unclear direction and misaligned strategies across the value chain lead to inconsistencies, inefficiencies and inertia, hindering meaningful, coordinated progress.

• Actions include: presenting a full ecosystem roadmap (2024-2027); develop circular key performance indicators (KPIs) and standardised metrics (priority action) (2027-2029)

Behavioural change: the medtech landscape is one in which linear products are the default choice, maintained by a lack of value placed on circular systems and limited support for change.

• Actions include: develop training and skills framework (2027-2029); develop behavioural change plan (2029-2031)

Commercial incentivisation: stakeholders are insufficiently incentivised, or in some instances are disincentivised to choose and deliver circular solutions.

• Actions include: circularity of medtech embedded in engagements and strategies (2024-2027); deliver value-based procurement for circularity of medtech products (2027-209)

Regulations and standards: UK regulatory regimes and technical standards predate circularity and have potential to further enable the medtech sector to recognise opportunities and align internationally.

• Actions include: Develop and maintain circular standards (including vocabulary); align regulatory environment for circular medtech with global counterparts; establish medtech as a core sector within UK circular economy work (2029-2031)

Physical and digital infrastructure: the existing physical and digital infrastructure and supporting services hold back the scaling of circular solutions, both locally and nationally.

• Actions include: develop a decontamination infrastructure framework; establish a materials recovery and recycling framework (2029-2031)

Transformative innovation: the innovation ecosystem is not tailored to circular objectives, impeding development of solutions.

• Actions include: Establish a medtech innovation centre (2027-2029) and identify areas where circular design research in needed (2029-2031)

Immediate actions include establishing governance structures, engaging with relevant strategies, precommercial collaboration, surveying stakeholders, and exploring opportunities for a medtech innovation centre. Priority research areas will focus on performance indicators, decontamination service models, regulatory barriers, and pilot projects for demonstrator products and services.

Businesses in this sector should keep abreast of developments with the roadmap and engage in any stakeholder consultations where relevant.

EU

European Parliament urges revision of medical devices regulations

On 23 October, the European Parliament adopted a resolution calling for urgent revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), highlighting significant challenges and proposing solutions to ensure the availability and safety of medical devices across the EU.

The resolution comes at a critical juncture. The MDR and IVDR, which were adopted to enhance the regulatory framework for medical devices and in vitro diagnostics, aimed to ensure higher standards of safety, transparency and clinical performance while fostering innovation. However, the implementation of these regulations continues to encounter significant challenges, necessitating a comprehensive review and revision. Read our Insight for more.