Products | UK Regulatory Outlook January 2025

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General / digital products

UK

Product Regulation and Metrology Bill

The Product Regulation and Metrology Bill, published on 4 September, has completed its committee stage and will next be read at the report stage. This bill is intended to modernise the UK's management of  product and metrology regulations and in practice is expected to facilitate closer alignment with European Union approaches.

The bill provides little detail as to how current legislation will be changed and instead delegates significant power to the secretary of state (and by proxy, the Office for Product Safety and Standards) to draft and introduce secondary legislation to enact changes.

The bill has been subject to a high level of scrutiny due to this low level of detail. A number of amendments  were proposed during the committee stage ranging from jurisdictional scope, environmental considerations, the definition of a product, the definition of an online marketplace, enhancements to consumer safety, reviews of technical standards and enforcement powers.

The importance of the bill for the UK's product regulatory framework cannot be overstated as it will form the primary UK legislation addressing product compliance for the next generation. Our key points to watch in 2025 will be (i) the potential change to the definition of a "product" to include intangible items, and (ii) the flexibility of the bill which could allow for a change of the definition of "online marketplaces".

The bill is estimated to receive Royal Assent in April or May 2025.

Tobacco and Vapes Bill

As reported in our November issue, the Tobacco and Vapes Bill was introduced and had its first reading on 5 November. The bill introduces a number of provisions relating to the sale and distribution of tobacco and vapes including prohibiting the sale of tobacco to people born on or after 1 January 2009. It also includes provisions about the licensing of retail sales and the registration of retailers, product information requirements, and to ban the manufacturing and sale of oral tobacco products such as snus. The bill passed its second reading on 26 November and a date for committee stage is yet to be announced.

A consultation on the Tobacco and Vapes Bill has been launched by the Public Bill Committee. Comments on the bill can be made until 30 January 2025.

Businesses affected by this legislation should keep on top of the bill's progress and understand the effect it will have on them.

To note, the bill sits separately to the recently introduced regulations banning the supply and sale of single-use vapes from 1 June 2025 as set out in our October Regulatory Outlook.

EU

EU General Product Safety Regulation

The EU's General Product Safety Regulation (GPSR) came into effect on 13 December 2024.

There are three key points to note:

• Products are subject to overarching safety requirements. They must be safe when placed on the market and remain safe throughout their lifespan. The definition of what is considered a product has been significantly expanded, covering intangibles such as freestanding software and AI tools as well as tangibles.
• Manufacturers must conduct ongoing risk analysis and maintain technical documentation for all their products for ten years.
• There have also been significant updates to packaging and labelling requirements to improve product traceability.

See our dedicated microsite for more on the GPSR.

While the GPSR does not apply directly to the UK, it is particularly relevant since the UK is in the process of updating its product safety regime. Based on industry feedback on the Product Regulation and Metrology Bill, it is evident that stakeholders are keen for an UK system that is closely aligned to the EU's and the UK regulator is aware of this. The GPSR is therefore a helpful indicator of the requirements that may be introduced in the UK.

EU Product Liability Directive

The EU Product Liability Directive entered into force on 8 December 2024. Member States have until 9 December 2026 to implement the directive into national law.

Key elements include an extension of the definition of a "product" to include digital files and software, clear allocation of civil liability when products are repaired by third parties outside of the original manufacturer's control, easier access to evidence for consumer claimants, and a new framework for assigning liability for damages arising from non-EU originating products.

Although the date of application for the new Product Liability Directive is not until the end of 2026, businesses will need to start taking steps now in order to prepare. For example, businesses should review their processes to guard against an increased risk of being sued over allegations that products are defective, and ensure that documentation related to products is updated to account for increased disclosure obligations.

If you would like to receive our infographic which sets out further detail on the incoming changes and practical steps you can be taking now, then please get in touch.

The directive can also be tracked through our Digital Regulatory Timeline.

EU Toy Safety Regulation

The European Parliament will continue to work on the Toy Safety Regulation (intended to replace the Toy Safety Directive) in 2025.

We will continue to monitor any updates released throughout the year. Please see a past Regulatory Outlook for the 2024 position.

Wild world of digital regulation

In the world of artificial intelligence (AI), a number of different pieces of legislation are coming to the fore. This software is now covered by the GPSR, the Product Liability Directive, and incoming obligations under the AI Act with the prohibited AI list taking effect in February 2025.

Also of note is the resumption of work on the AI Liability Directive. It is not yet clear what direction the legislation with take with Nils Behrndt, from the European Commission, indicating at a recent meeting that discussions have proven challenging.

The key point to take away here is that there is a lot of new law coming into play which will alter the regulatory landscape for digital technologies throughout 2025 and beyond.

EU Cyber Resilience Act

The Cyber Resilience Act (CRA) will introduce cybersecurity requirements for products with digital elements which aim to protect consumers and businesses from products with inadequate security features. The CRA will require manufacturers to ensure that their products meet minimum technical requirements for cyber security from the design and development phase and throughout the whole product lifecycle. It is possible this could include carrying out third-party conformity assessments.

Certain types of products with digital elements deemed safety critical will be subject to stricter conformity assessment procedures, reflecting the increased cyber security risks they present.

The proposal also introduces transparency requirements, by requiring manufacturers to disclose certain cyber security aspects to consumers.

The CRA entered into force on 10 December 2024. The CRA has a 36-month transition period, meaning it will apply from 11 December 2027.

Product sustainability

UK

Government announces reforms to WEEE to bring OMPs under regulations

The government has published its response to the consultation on reforming the producer responsibility system for waste electricals. The consultation sought views on: introducing a producer-financed household collection system for waste electrical and electronic equipment (WEEE); enhancing retailer obligations for free collection on delivery, in-store takeback and customer communication; designating online marketplaces as producers with obligations similar to UK manufacturers and importers; creating a new category for vapes, with costs borne by those placing them on the market; and establishing a new WEEE scheme administrator.

The devolved nations will respond to these proposals in full in 2025 but will implement the following immediate changes:

New obligations for online marketplaces

• When facilitating sales into the UK market from overseas traders, online marketplaces will need to contribute to the cost of collection, treatment, reuse and recycling of WEEE; and
• online marketplaces will need to join an approved WEEE compliance scheme, pay a registration fee and report data on the weight of electrical and electronic equipment placed on the UK market by overseas traders.

A new category for vapes

• Will amend regulations to require vape producers to report product weight in a new category.
• Will amend WEEE reporting obligations to reflect the new category.

Regulations will be amended in 2025, with obligations starting in 2026.

Ban on single-use vapes comes into force on 1 June 2025

The Environmental Protection (Single-use Vapes) (England) Regulations 2024 have been made and come into force on 1 June 2025. The regulations ban the sale and supply of single-use vapes from 1 June 2025, allowing businesses sufficient time to adapt and run-down remaining stock.  A single-use vape is one which is not refillable and/or rechargeable.

Businesses that sell and supply single-use vapes will need to ensure that from 1 June 2025 they are not placing these products in the market or they could risk enforcement action being taken against them.

Regulations made to introduce the extended producer responsibility regime for packaging

The regulations introducing the extended producer responsibility regime (EPR) - the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 (EPR regulations) - were made on 11 December 2024 and came into force on 1 January 2025. The EPR scheme obligates producers of household packaging waste to pay the full cost of the disposal of this waste. The EPR regulations set out the producers who are obligated under the EPR and requires in-scope producers to record-keep and report their packaging data, continue to ensure that a proportion of the packaging they supply by material type (card, glass, plastic, metal, etc) is recycled and to provide evidence of recycling to the regulator, as well as obligating producers to assess the recyclability of packaging.

The EPR regulations allow for both civil and criminal sanctions. Initially, regulators will help businesses to achieve compliance, but civil and criminal penalties can be imposed if necessary. Regulators may issue compliance notices or variable monetary penalties, with criminal sanctions applied only in severe cases which, if appliable, would result in a fine. As such businesses in scope need to ensure throughout 2025 they are complying with the requirements of the EPR regulations, such as reporting relevant data (see below).

Businesses to start paying fees under EPR from October 2025

Throughout 2024, businesses in scope of the EPR scheme have been collecting and reporting relevant data. The first fees under the EPR scheme are due from October 2025 using the data collected from 2024. Businesses within scope must ensure that they pay any related fees.

Businesses in scope should also be aware that from January 2025, the data for 1 July to 31 December 2024 needs to be reported. The deadline to report this data by is 1 April 2025.

Reporting packaging recyclability under EPR

From 1 January 2025, liable producers who supply household packaging must assess the recyclability of that packaging and report the results of the assessment to the relevant environmental regulator. Only large producers must report their recyclability assessment data. The first reports under the EPR regulations must be submitted on or before 1 October 2025, for the period 1 January to 30 June 2025.

In line with this, guidance has been published outlining how to assess the recyclability of packaging and states that packaging will be categorised using a red, amber, green rating system, which will influence disposal fees through "fee modulation". Full details of how fees will be modulated is to be published in 2025. The guidance also sets out what businesses can do to get help assessing packaging, which includes using third party providers and adds that an official register of compliance schemes will be published by PackUk (part of the Department for Environment, Food & Rural Affairs) in 2025.

Businesses in scope must ensure they, or a third party provider, carry out these recyclability assessments of its household packaging and submit the results of these by 1 October 2025.

Changes to separation of waste for businesses from 31 March 2025

From 31 March 2025, the  Separation of Waste (England) Regulations 2024 will start to apply which legally requires businesses and relevant non-domestic premises in England to separate their recyclable waste, with the exception of garden waste. Business will be required to separate their waste into the following three streams: dry recyclable materials (plastic, metal, glass, paper and card); food waste; and black bin waste (residual waste).

By default, businesses need to separate paper and card from other dry recyclables unless the relevant waste collector collects them together or they apply an exemption as detailed below. Businesses should discuss how dry recyclable waste will be collected with their chosen waste collector.

Businesses are able to co-collect paper and card with other dry recyclable materials where separate collection is technically or economically impracticable or provides no significant environmental benefit. If relying on one or more of these exemptions, businesses will need to produce a short-written assessment explaining their decision and substantiating this with evidence. Guidance has been published to assist businesses with this.

Preparing for the Deposit Return Scheme

As reported in our November issue, the UK government has committed to implementing a deposit return scheme across England, Northern Ireland and Scotland in October 2027 and has laid draft regulations for the scheme. In 2025, we expect these regulations to be made into law and for the government to work with industry to ensure the DRS is developed in a way that works for businesses as well as consumers. Businesses should continue to engage with the government, where relevant, as plans for the DRS progress.

Circular economy strategy

The government has formed a Circular Economy Taskforce which will help build a circular economy in the UK and help to end the throwaway culture. Scotland, Wales and Northern Ireland have already published strategies on how they are committed to the circular economy and the UK government will be publishing its strategy for England in 2025.

The UK government and devolved nations are discussing plans for wider reforms reflecting strategic priorities in the drive towards a circular economy across the UK and this will be set out in 2025. Businesses should keep abreast of the government's plans for moving toward a circular economy as this is likely to involve regulatory changes.

EU

Packaging and Packaging Waste Regulation enters into force

On 16 December 2024, the Packaging and Packaging Waste Regulation (PPWR) was formally adopted by the Council of the EU, marking the end of its legislative journey. The regulation will now be published in the EU’s Official Journal and will enter into force. The regulation will be applied 18 months after the date of entry into force.

The PPWR introduces several significant changes to packaging regulations, including:

• By 2030, all packaging must be recyclable, with specific criteria and performance grades to be established. Some exemptions apply, such as for certain medical products.
• Plastic packaging must contain a minimum percentage of recycled content, with specific targets set for 2030 and increasing by 2040.
• An "empty space" ratio limit of 50% will be enforced.
• Packaging must be minimised in weight and volume to the minimum whilst ensuring its functionality.
• A harmonised labelling system will be introduced to simplify sorting and disposal.
• Certain single-use plastic packaging formats (such as individual portions of condiments, sauces, milk creamer and sugar in hotels, bars and restaurants) will be banned from 2030.
• The use of per- and polyfluoroalkyl substances (PFAS) in food contact packaging will be restricted under de minimis thresholds 18 months from when the PPWR enters into force (approximately mid-2026).
• Extended producer responsibility obligations will require businesses to contribute financially to packaging waste management.
• By 1 January 2029, mandatory deposit return schemes will be introduced for single-use plastic and metal beverage containers.
• Three years after the PPWR enters into force, the takeaway sector must offer reusable packaging options for hot or cold beverages and ready-prepared food.

The PPWR will significantly impact businesses operating within the EU. With the legislation now confirmed, it is crucial for businesses to familiarise themselves with the upcoming changes and understand their implications. These new measures will necessitate adjustments in packaging practices, including the methods and materials used for packaging products.

Ecodesign for Sustainable Products Regulation

The Ecodesign for Sustainable Products Regulation (ESPR) entered into force on 18 July 2024. Over time, the regulation will extend the current ecodesign framework to all physical goods placed on the EU market. This will be done  via delegated acts introduced by the European Commission.

At the end of 2024, the Commission called for applications for the Ecodesign Forum. This forum is a group of experts on ecodesign for sustainable products and energy labelling who will act as an advisory body to the Commission in relation to the ecodesign requirements they will introduce.

The Commission is to adopt the first working plan under the ESPR by 19 April 2025, which will outline which products will be prioritised over the coming years in terms of secondary legislation. The Commission is expected to prioritise a number of product groups in its first working plan, including iron, steel, aluminium, textiles (notably garments and footwear), furniture, tyres, detergents, paints, lubricants and chemicals. Once published, businesses should review the working plan to understand which product groups will soon be subject to new ecodesign requirements and whether this will impact them.

The ESPR provision banning the destruction of unsold consumer products comes into force on 19 July 2026. The first products to fall within this are footwear, apparel and clothing accessories so those businesses who place these products on the Union market should be preparing throughout 2025 ahead of this prohibition.

FAQs on the ESPR can be found here.

Right to repair

The Right to Repair Directive entered into force on 30 July 2024. This legislation aims to promote sustainability by increasing the repair and reuse of defective products. It introduces obligations for producers to repair goods and amends consumer rights for defective products.

Member States will need to implement national laws, regulations and administrative provisions to comply with the directive by 31 July 2026. Currently the right to repair only applies to those products which have repairability requirements as set out in ecodesign legislation, such as fridges and washing machines. However, this list will expand as further ecodesign requirements for products are introduced via the ESPR.

In 2025 businesses should consider whether the design of their products may need to be changed to make repairs easier and whether opportunities are presented to them by new repairs and refurbishments. Additionally, it would be advisable to start communicating changes within supply chains so all are aware of what is on the horizon.

See our previous Eating Compliance for Breakfast webinar recording and relevant slides on the directive.

New ecodesign requirements for smartphones and slate tablets to come into effect

New  ecodesign requirements will apply from 20 June 2025 for smartphones, mobile phones other than smartphones, cordless phones and slate tablets. Manufacturers should have been preparing themselves for these new requirements throughout 2024 and should continue to do so in early 2025 ahead of it coming into effect.

The legislation requires, among other things, that devices are able to be effectively repaired and that spare parts should be available to professional repairers or end users, and it introduces requirements to ensure devices are protected from dust and water and are resistant to accidental drops.

Examples of practical steps businesses could take include communicating with supply chains regarding the requirement for spare parts and thinking about the design of products and how they might be made more durable or more easily repairable.

Energy labelling of smartphones and slate tablets to come into effect

As detailed in a past Regulatory Outlook, the European Commission proposed new rules relating to the energy labelling of smartphones and tablets which have been published in the EU Official Journal.

Devices that are put onto the Union market will have to display information on their energy efficiency and battery endurance, as well as displaying a repairability score.

These rules will apply from 20 June 2025 and manufacturers should have been preparing themselves for these new requirements throughout 2024 and should continue to do so in early 2025. Part of this preparation should include building an understanding of how to calculate repairability scores and ensuring the correct energy efficiency labels are applied to products in scope.

Updates on PFAS restrictions

In November we reported on the European Chemicals Agency's (ECHA) update on the progress of its restriction proposal for per- and polyfluoroalkyl substances (PFAS). In 2025 further updates will be provided by ECHA on the restrictions affecting PFAS.

Further to this proposal which looks at restricting around 10,000 PFAS, the European Commission also adopted new measures under REACH to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA ‑related substances. These are sub-groups of PFAS (see our October issue for more). These restrictions will start to apply from 10 October 2026 so during 2025 businesses who will be impacted by these measures should be preparing for these changes.

Sustainable Batteries Regulation

The EU Sustainable Batteries Regulation came into effect on 18 February 2024. Obligations under the regulation are being implemented through a phased approach. CE marking rules are already in place, requiring all batteries, whether incorporated into products or supplied separately, to be CE marked.

In 2025 further obligations will come into effect. From 18 August 2025:

• All batteries will need to bear a "separate collection symbol".
• Due diligence requirements need to be complied with if an economic operator meets the following thresholds: have a net turnover of €40 million or more in the penultimate financial year; or are part of a group which exceeds the limit of €40 million.
• Extended producer responsibility will apply to batteries meaning producers will be responsible for the end of life collection and treatment of batteries.
• Member States must lay down rules on applicable penalties. These must be "effective, proportionate and dissuasive" and will vary across EU Member States.

Businesses should review the regulation to determine applicability to their batteries and ensure compliance with upcoming changes.

Further, from 18 February 2027, products with portable batteries must be designed so that the batteries are readily removable and replaceable by the end user during the product's lifetime. Some narrow exclusions apply for products designed for use in water and certain medical devices, and instead these batteries only need to be removable by an independent professional. While this obligation is further down the line, in 2025 businesses should be looking to their product designs to understand what changes may need to be made to comply with this requirement.

European Parliament: resuming unfinished business

On 13 November 2024, the European Parliament (EP) announced the list of legislative files under Rule 250 which it will resume business in the new legislature. Generally, if the EP does not conclude work on a file before it breaks up for the European elections, the file is deemed to have lapsed. However, under Rule 250 of the EP Rules of Procedure, the EP's Conference of Presidents can decide to continue work on unfinished files. One of these files was the amendments to the Waste Framework Directive. This amendment, as currently drafted, will introduce new measures to support the circular economy and reduce waste from textiles in the EU including for Member States to introduce extended producer responsibility (EPR) schemes for textile waste.

Businesses have a preparation window for the EU Deforestation Regulation

Please see ESG.

Carbon Border Adjustment Mechanism: looking ahead

Please see ESG.

Life sciences and healthcare

Medical Device regulatory reform

At the start of 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released its roadmap on the future regulatory framework of medical devices with core elements of the new framework expected to be in place in 2025. A reminder of the progress the MHRA has made so far is as follows:

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 were made on 16 December 2024. These regulations amend the Medical Devices Regulations 2002 to impose more stringent requirements and obligations on manufacturers to undertake post-market surveillance (PMS) practices on their medical devices. Changes being introduced include to PMS system and plan, preventative actions and reporting obligations. They come into force on 16 June 2025. See our Insight for more.

A consultation on routes to market for medical devices and in vitro diagnostic (IVD) devices ran from 14 November and closed on 5 January (see our November issue for more). The responses received will be used to shape the regulatory reform.

The MHRA updated its roadmap in December outlining that the PMS SI is to pass by January 2025 with guidance to be published in June. It also sets out that the response to the consultation on routes to market for medical devices and IVDs will be published in early/mid 2025, with the regulations to be introduced by the end of 2025. It is important to note that this document is live and so subject to change.

2025 will be a pivotal year for medical device regulatory reform in the UK. Businesses must stay informed about the upcoming changes and understand their implications for compliance.

Regarding developments in the EU, the EU implemented the EU Medical Device Regulation (MDR) in 2017 to replace existing directives, however it did not come into force until 26 May 2021 due to delays caused by the Covid-19 pandemic. The MDR reforms included expanding the definition of "medical device" to include previously unregulated products like cosmetic contact lenses and introduced stricter conformity assessment procedures, risk-based classifications, and increased obligations for high-risk devices.

Despite progress, significant delays have occurred in transitioning to the new rules due to a shortage of notified bodies, supply chain issues, and manufacturers' unpreparedness. To prevent further disruptions, the Commission extended the transition periods for compliance: high-risk devices until December 2027, medium-risk devices until December 2028, and lower-risk devices until December 2029.

The Commission has also launched a new consultation on the effectiveness of EU regulations on medical devices and in vitro diagnostic medical devices. Comments are to be made by 21 March 2025.

See our Insight for more on medical device reform in the UK and EU.

MHRA and AIaMD

Last year, the MHRA launched the AI Airlock which is a regulatory sandbox for AI as a medical device (AIaMD) (previously covered here). The project is intended to help the MHRA identify and address challenges in regulating AIaMD.

In December, the MHRA announced the selection of five innovative AI technologies for its AI Airlock pilot scheme. The manufacturers will be able to test their products and collect evidence under the supervision of the MHRA which will then support the approval of their product. The findings from the pilot will be announced in 2025 and will inform future AI Airlock projects and influence future UK AI Medical Device guidance.

Businesses seeking to bring AIaMD to the UK market should, when made available, review the findings published from the pilot to understand how the regulatory framework may be changing for AIaMD.  Additionally theMHRA intends to publish guidance on cybersecurity and human factors specific to AIaMD by spring 2025 which businesses should keep an eye out for.

Additionally, with the MHRA's 2024/25 business plan focusing on innovation, alongside the creation of the new Regulatory Innovation Office (RIO) (see our Insight for more) which will initially be focusing on digital healthcare, we anticipate there to be further progress made in the AIaMD sphere in 2025.

See also our Insight 'Is the MHRA creating the right conditions to encourage UK investment in AI products?' for a detailed examination of the MHRA's strategic approach to AI.

Clinical trials regulatory reform

On 12 December the UK's new clinical trials regulations were laid before Parliament. Once made into law, these will come into force following a 12-month implementation period. The changes were trailed via a 2022 consultation and government statements since. Some of the changes that will have most impact for sponsors and clinical research organisations include:

• "Combined Review" - This is a change to the approval procedure for clinical trials, combining what had been separate applications for authorisation from the MHRA and Ethics Committees - This aims to speed up the procedure for approval, to under 60 days.
• Research Ethics Committees (RECs)-  Specific requirements for the make-up of RECs have been dropped, and replaced with provisions in line with international good clinical practice standards. This may reduce some of the barriers to launching a clinical trial.
• Transparency - This is now a key principle, with requirements to register trials in a public register, and publish a summary to share outcomes with participants. It is hoped that making research and results publicly available will encourage participation.
• Consent - Processes to seek and record participant consent are to be simplified in "lower risk" trials. This will interest manufacturers of medicines that have already been approved but show promise in treating additional conditions.

The new regulations, brought in via amendments to the Medicines for Human (Clinical Trials) Regulations 2004, are an example of the UK's approach to updating legacy EU regulations since Brexit. The UK government sees these changes as promoting the UK as a venue for high-quality clinical trials, to improve treatment for patients in the NHS and attract investment in the UK economy. In light of these reforms, industry and government will be watching trends relating to numbers of trials held in the UK and rates of patient participation.

The MHRA recently ran a webinar on implementing the new clinical trials regulations which you can watch here. Within this it was outlined that throughout 2024 the MHRA has been developing guidance on the regulations and started stakeholder engagement in November 2024, which will continue until March 2025. In March/April 2025 the final draft-guidance will be published, with the aim of publishing the final guidance in August 2025. Businesses should engage with the MHRA to help finalise this guidance.

Reform of the NHS

In 2025, significant reforms to the NHS are expected to be announced, with Wes Streeting to publish his 10 year Health Plan in spring  2025 detailing the government's plans on reforming the NHS.

Lord Darzi's recent report highlights several key areas for potential reform, including digital transformation, clinical trials, health data, and AI. The report underscores the need for integrating advanced digital solutions, simplifying clinical trial processes, leveraging rich health datasets, and adopting AI to enhance patient care.

The government's response indicates a commitment to long-term reform, suggesting that these areas will be focal points in the upcoming changes. Businesses should review the 10 year Health Plan when published to understand what changes the government is looking to introduce and how this might impact them.

Windsor Framework: changes now in force for medicines

Changes to the supply of medicines from Great Britian to Northern Ireland (NI) being introduced under the Windsor Framework (WF) came into force on 1 January 2025. Under the WF, the MHRA will now licence all medicines, that previously required EU-wide authorisation, in accordance with UK law which will require "UK Only" labelling . This allows all types of medicines to be supplied with a single licence and pack for the entire UK. The MHRA has produced guidance which explains the main changes the WF introduces and also see our September issue for more.

Businesses that are placing medicines on the NI market should review this guidance to ensure they are familiar with these changes and are complying with the new rules.

Relaunch of the Innovative Licensing and Access Pathway

The MHRA has published a statement of policy intent on relaunch of the Innovative Licensing and Access Pathway (ILAP). The ILAP is a pre-market pathway which comprises of an innovation Passport designation and  a target development profile and provides applicants with access to a toolkit to support the design, development and approvals process. The ILAP is "focused on getting the most transformative new medicines to patients in the NHS more quickly."

The new ILAP will target medicines that have not started their confirmatory trials, providing more chances to benefit from the pathway's support. Key improvements include:

• Enhanced bespoke service through selective entry and dialogue between ILAP partners and developers.
• Simpler roadmap and more predictable timelines for better planning.
• NHS involvement as a core partner, focusing on operational planning and system readiness for new medicines.
• Prioritised scheduling for ILAP Joint Scientific Advice, Access Forums, MHRA scientific advice, pre-submission meetings, and access to Clinical Practice Research Datalink.
• Future-proofing to accelerate access for transformational products, including drug-device combinations.

The new ILAP will open to applications in March 2025, with full details of the pathway to be published in January 2025 so businesses interested in applying should review this when published.

Regulations for medicines manufactured at the ‘point of care’ and modular manufacturing

As previously reported, 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.

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 which we expect to happen in early 2025. Detailed guidance on the new framework will be published by the MHRA in advance of the regulations coming into force.

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

Last year, the Department of Health and Social Care 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. Further details of this can be found in our October issue, but we anticipate further information to be published on this in 2025.  Businesses should keep abreast of developments with the roadmap and engage in any stakeholder consultations where relevant.