Products | UK Regulatory Outlook March 2025

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UK

Product Regulation and Metrology Bill completes reading in House of Lords

On 12 March 2025, the Product Regulation and Metrology Bill passed its third reading in the House of Lords, following the completion of the report stage on 5 March. Key amendments and discussions during these stages include:

• A debate during report stage on the bill's application to AI products and software. An amendment was agreed to clarify that the definition of intangible components includes software. Other than this, the bill does not contain any express reference to AI.
• Concerns were raised about possible dynamic alignment with EU regulations with implications for sovereignty of product safety laws. No amendments were accepted to restrict alignment, but improvements to parliamentary scrutiny were agreed. These included an amendment that requires the secretary of state to publish a specific statement explaining how the government identifies and assesses product safety risks before laying secondary legislation, including how it is determined that some products may present a higher risk than others, and an amendment requiring the secretary of state to consult relevant stakeholders before making regulations under the Act.
• An amendment was made requiring the affirmative parliamentary procedure for a broader range of secondary legislation made under the bill which requires approval from both Houses of Parliament.
• The scope of Henry VIII powers were reduced including removing the ability to make consequential changes to the Consumer Rights Act 2015.
• A number of concerns had been raised about the sale of unsafe products via online marketplaces. The government accepted amendments which clarify the definition of online marketplaces and ensure that online platforms, including those that are part of a larger network, are within the bill's scope. The government committed to engage further with stakeholders to address safety concerns around online marketplaces.

A new version of the bill incorporating the amendments agreed has been published and has been introduced to the House of Commons. The date of its second reading is to be announced.

Amendments to the Product Security and Telecommunications Infrastructure Act

The Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) (Amendment) Regulations 2025 were made on 24 February 2025 and came into force on 25 February 2025. The changes made by these regulations exempt the following categories of products from the Product Security and Telecommunications Infrastructure Act: motor vehicles agricultural, two- or three-wheel vehicles and quadricycles, and forestry vehicles.

The amending regulations also clarify that where a manufacturer of relevant connectable products extends the minimum length of time for which security updates relating to such products will be provided, the new minimum length of time must be published as soon as is practicable.

The government has updated its guidance in line with these changes.

Crime and Policing Bill to increase penalties for those selling knives

The Crime and Policing Bill has been introduced in the House of Commons and has its second reading on the 10 March. One of the key aims of the bill is to take tougher action on knife crime. This includes enhancing the ability of law enforcement agencies to clamp down on knife crime including an increase the maximum penalty, from six months’ imprisonment to two years’ imprisonment, for the offences of private possession, importation, manufacture, sale or supply of prohibited offensive weapons and knives and of selling knives to those under 18. The bill will be read at committee stage on 27 March 2025.

See more on the bill in the Digital regulation section.

EU

Consultation on technical description of important and critical products with digital elements

The Cyber Resilience Act requires the Commission to specify the technical description of the categories of important and critical products with digital elements listed in Annex III and IV to the regulation. These products may be subject to more stringent conformity assessment procedures.

On 13 March 2025, the European Commission opened a consultation seeking feedback on the implementing regulation that will specify technical descriptions for these products. The implementing regulation will detail specifications for products listed in Annexes III and IV of the Act.

The consultation closes on 15 April 2025.

Sustainable products

Have you submitted your 2024 packaging data for EPR?

On 1 April 2025, large organisations within scope of the extended producer responsibility (EPR) scheme for packaging must submit their July-December 2024 data. Small organisations must also submit their January-December 2024 data by this date.

Businesses that place packaging on the UK market must check whether they fall within scope of the EPR and if so, submit the relevant data by this deadline. For more on the EPR, see our January Regulatory Outlook.

Businesses should also note that under the EPR scheme, liable producers who supply household packaging must assess the recyclability of that packaging and report the results of the assessment to the environmental regulator. These reports must be submitted by 1 October 2025. To assist businesses with these assessments, Defra has this month published a decision tree illustrating the process for deciding the recyclability of materials under the recyclability assessment methodology. Businesses in scope should use this decision tree to assist them with their assessments ahead of the October deadline.

Simpler recycling is round the corner

As reported last month, the government's new rules on simpler recycling will legally require businesses and relevant non-domestic premises in England to separate their recyclable waste, with the exception of garden waste. The rules come into force on 31 March 2025. Businesses should ensure the necessary measures are in place by this date in order to comply with these new changes.

Lifesciences and healthcare

What does the abolishment of NSHE mean for manufacturers of medical devices and pharmaceuticals?

This month the government announced that it will be abolishing NHS England (NHSE) and will merge it with the Department of Health and Social Care to bring it back under "democratic control" So what will this mean for manufacturers of medical devices and pharmaceuticals?

Manufacturers of medical devices and pharmaceuticals will want to see how these reforms dovetail with the work the government is doing on its 10-year health plan for the NHS. The government has stated that its focus will be on reforming the current healthcare model by moving from analogue to digital systems, and by putting an emphasis on prevention of sickness.

NHSE is being scrapped soon after the government's creation of the Regulatory Innovation Office (RIO). RIO was launched in October 2024 and is intended to support the regulatory system in bringing innovative products and services to market more swiftly, including digital health products, medicines and services.

Manufacturers will hope that by integrating NHSE's functions into the DHSC, the healthcare system will be able to provide greater political support, and public money, for the adoption of innovative life sciences products that support the aims of RIO and the government. These aims are expected to receive further impetus when new pre-market medical device regulations, and associated Medicines and Healthcare products Regulatory Agency (MHRA) guidance, is brought in during 2025 and 2026.

MHRA and NICE set out pledges as part of government's wider regulatory reform

On 17 March 2025, the government published a policy paper "New approach to ensure regulators and regulation support growth". This sets out the actions it plans to take to reform the regulatory system in a bid to promote growth and investment. See our Insight for more.

Within this paper, there is a section dedicated to key regulator pledges which both the MHRA and the National Institute for Health and Care Excellence (NICE) fed into. From July 2025, the MHRA will permit point-of-care manufacturing of medicines. NICE is aiming to reduced evaluation time by a quarter and will look to complete 60% of Technology Appraisals within 240 working days by 2025/26 (this year it 40% were completed in this time frame).

To improve alignment between MHRA decision and NICE guidance publication, the regulators will develop concurrent marketing authorisation and technology appraisal processes to reduce approval times for new medicines as well as launching an integrated pre-market scientific advice service.

With the government pushing regulators to prioritise growth and reduce regulatory burden on businesses, it will be important for businesses to watch carefully as to how both the MHRA and NICE respond to these demands and further changes may be introduced.

Medical Devices (Amendment) (Great Britain) Regulations 2025

The government has agreed to retain four pieces of assimilated EU law that were due to be sunsetted (due to expire) on 26 May 2025 in order to avoid regulatory disruption, which will be welcomed by businesses. The amending regulations to implement this have been made, The Medical Devices (Amendment) (Great Britain) Regulations 2025. These amend the Medical Devices Regulations 2002 by removing the 25 and 26 May 2025 revocation dates of the following pieces of assimilated EU law:

• Commission Decision 2002/364 (on common technical specifications for in vitro medical devices).
• Commission Regulation (EU) No 207/2012 (on electronic instructions for use of medical devices).
• Regulation (EU) No 722/2012 (concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin).
• Regulation (EU) No 920/2013 (on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices).

Proposed review of the 2025 scheme to control the cost of branded health service medicines

On 14 March 2025, a consultation was launched in regards to proposed amends to the legislation setting out the statutory scheme for branded medicine pricing. The consultation outlines that for operational purposes, the statutory scheme needs to be updated on the first date of a new quarter, and 1 July 2025 is the earliest feasible date for implementation of the proposals set out in this consultation.

It proposes to increase the statutory scheme headline payment percentage for 2025 to 23.8%. This will then increase to 24.7% for 2026, and 26.4% for 2027.

It is also proposing to amend the baseline adjustments made in the previous consultation so that the total value of the baseline adjustments is unchanged, but the implementation of two-thirds of the adjustment intended for 2025 is delayed to 2026. Lastly, it is also proposing to introduce new data assurance requirements for presentation level data returns.

The consultation closes on 25 April 2025. Those in the pharmaceutical industry should review the consultation and consider whether they wish to respond.