Healthcare: Medical Devices 2024 Comparisons

Medical Devices

The UK has long been recognised as a leading jurisdiction in product safety laws, including those applicable to medical devices and consumer health products. Given its only recent departure from the EU, the UK’s current product safety regime is largely modelled on EU laws. However, due to either necessity or policy-driven departures in the wake of Brexit, UK-specific laws have become more prevalent as more time passes since the UK’s departure from the EU.

Overall, the UK product safety regime is multifaceted and involves the operation of several layers of laws, which are ultimately designed to balance the rights of end users and patients with those of business and the need for innovation.

UK Product Safety Legislative Regimes

As it pertains to medical devices and consumer health product categories, the UK product safety legislative regime has the following key legislative pillars, similar to the EU system on which it is based.

Separate product safety regimes

Given their comprehensive nature, these operate independently from any other product safety legislation, for products recognised to have unique risks. Of relevance for medical devices and consumer health products, such regimes include:

• medical devices;
• pharmaceuticals; and
• food and nutrition supplements.

Supplementary sector-specific safety requirements

These work in concert with the below general product safety regimes, to have effect where there are specific risks introduced by recognised product categories. The following sector-specific laws are relevant to medical devices and health products:

• biocides;
• cosmetics;
• chemicals; and
• personal protective equipment (PPE).

General product safety regime

This regime imposes overarching requirements for the product safety of consumer products in the UK, and tends to operate where the aforementioned regimes and/or no more specific requirements have effect.

Generally, these regimes have the following core features:

• the application of the correct product safety regime (see 1.5 Borderline Products);
• mandatory pre-marketing steps, including product safety assessments (see 2.4 Marketing and Sales);
• the involvement of third-party bodies to determine compliance with technical standards, as a basis for a presumption that the product meets safety requirements (see 2.4 Marketing and Sales);
• record-keeping requirements, including the creation and maintenance of technical fields to document regulatory compliance, as well as records of complaints or issues linked with the product (see 2.6 Post-marketing Obligations, Including Corrective Actions and Recalls); and
• post-market surveillance obligations imposed on various actors in the supply chain, including regarding corrective action and notifications to authorities (see 2.6 Post-marketing Obligations, Including Corrective Actions and Recalls).

Overview of Specific Regimes

Medical devices

Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which give effect to EU Directives 93/42/EEC and 98/79/EC on medical devices and in vitro diagnostics (IVDs) respectively.

These Regulations continue to have effect in the UK, in the form in which they existed on 1 January 2021 following the expiry of the Brexit implementation period.

In practical terms, the UK MDR 2002 provides for the manufacturer to successfully perform the required pre-market conformity assessment and to establish sufficient procedures to fulfil their post-marketing surveillance and vigilance reporting obligations. All obligations under the UK MDR 2002 are enforced via the criminal law in the UK. Offences for breach of the UK MDR 2002 are set out in the Consumer Protection Act 1987, with penalties for offences including imprisonment for up to six months, an unlimited fine, or both.

A new legislative suite – a revised version of the aforementioned sources of EU law for current UK regulations – applies to medical device products in the EU. The EU Medical Devices Regulation (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) have applied in EU member states since 26 May 2021 and 26 May 2022 respectively.

As these regulations did not take effect during the transition period, they were not EU law that was automatically retained in the UK. However, the UK is preparing to introduce similar domestic legislation.

There are, however, applicable transition periods to allow EU-compliant products to continue to circulate in the UK market. CE-marked general medical devices compliant with the EU Medical Devices Directive or EU Active Implantable Medical Devices Directive with a valid declaration continue to be accepted in England, Scotland and Wales (Great Britain – GB) until the sooner of the expiry of the certificate or 30 June 2028. CE marked general devices and in vitro devices compliant with the EU MDR and EU IVDR can be placed on the GB market until 30 June 2030. From 1 July 2030, the new UK Conformity Assessed (UKCA) mark requirements is available to manufacturers wishing to place medical devices on the GB market.

On 11 February 2021, the Medicines and Medical Devices Bill became law as the Medicines and Medical Devices Act 2021 (“the MMD Act”). This Act gives the Secretary of State powers to amend the existing regulatory framework regarding human and veterinary medicines, and medical devices in the UK. It aims to provide the UK with an easier regulatory route to move away from EU laws and to regulate these medical products via amendments to the existing GB laws. It also aims to enhance patient safety whilst encouraging innovation.

In November 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the UK’s existing regulatory framework governing medical devices. On 26 June 2022, the UK government published its response to the consultation on the future regulation of medical devices in the UK, which indicates that certain aspects of the future regulatory framework will have some alignment with the EU MDR. The response bases the future medical device regulatory framework around five pillars:

• strengthening the MHRA’s powers to act to ensure patient safety;
• making the UK a focus for innovation and the best place to develop and introduce innovative medical devices;
• addressing health inequalities and mitigating biases throughout medical device product life cycles;
• proportionate regulation to support businesses through access routes that build on synergies with EU and global standards; and
• setting world-leading standards, building the UKCA mark as a global exemplar.

The future regime is expected to apply from 1 July 2025.

Also worth noting are the 9 January 2024 MHRA roadmap for the delivery of the future framework for medical devices and the draft statutory instrument on Post-Market Surveillance published in July 2023.

PPE

The relevant product safety regulations for PPE depend on the type of product and the intended use of the product – largely whether it serves to protect the wearer or the public. A good example of the delineation of classification of these products is the face mask, the popularity and widespread use of which skyrocketed during the COVID-19 pandemic.

• Surgical (medical) face and transparent face masks that are intended for healthcare staff to wear to protect patients during surgical procedures and other medical settings are Class I medical devices and must comply with the design and safety requirements of the Medical Device Regulations 2002.
• Face masks that are intended to protect the wearer are considered as PPE and regulated under the Personal Protective Equipment Regulations 2016/425, which is enforced by the Personal Protective Equipment (Enforcement) Regulations 2018.
• Face coverings intended for use by the general public are not PPE or medical devices but must comply with the General Product Safety Regulations 2005 (GPSR), which set out the responsibilities of the producers and distributors of consumer products.

Medical instruments

Medical instruments are generally considered as medical devices and are therefore subject to the UK MDR 2002, as noted.

In recent years, there has been an increasing number of consumer products that are not medical in nature, but that may be related to health and wellbeing. This trend is thought to reflect the behaviours of a health and wellbeing-driven modern consumer. However, the products present regulatory challenges given their tendency to incorporate several safety-critical elements and be used broadly by consumers without much specialist knowledge or for self-treatment of minor health issues.

Cosmetics

All cosmetic products placed on the UK market intended for sale or to be given away for free in the course of a commercial activity must comply with:

• Schedule 34 of the Product Safety and Metrology Statutory Instrument (the “UK Regulation”) for cosmetics marketed in Great Britain (England, Wales, and Scotland), which implements the EU-derived cosmetics laws to which the UK has always adhered; and
• Regulation EC 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products for cosmetics marketed in Northern Ireland (this is in accordance with the terms of the Windsor Framework agreed on 21 March 2023).

The UK Cosmetics Regulation is enforced in Great Britain via the UK Cosmetic Products Enforcement Regulations 2013, which specify the role of the authorities, the penalties, and the enforcement process.

Biocides

New independent chemical regulatory regimes have been introduced into the UK since the withdrawal from the EU, including:

• the GB (England, Scotland, and Wales) Biocidal Products Regulation (GB BPR);
• the GB Classification, Labelling, and Packaging Regulation (GB CLP);
• the GB Prior Informed Consent (PIC) Regulation (GB PIC) concerning the export and import of certain hazardous chemicals;
• Regulation (EC) 1107/2009 concerning plant protection products (PPP); and
• the UK REACH Regulation (Registration, Evaluation, Authorisation, and Restrictions of Chemicals) concerning the procurement of chemical substances directly from EU REACH-registered suppliers.

Food and Nutrition Supplements

Food supplements are regulated by legislation applicable to each locale in the UK, as follows:

• England – the Food Information Regulations 2014 and the Food Supplements (England) Regulations 2003.
• Wales – the Food Information (Wales) Regulations 2014 and the Food Supplements (Wales) Regulations 2003.
• Northern Ireland – the Food Information Regulations (Northern Ireland) 2014 and the Food Supplements Regulations (Northern Ireland) 2003.

On 1 January 2021, the Nutrition (Amendment etc) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc) (EU Exit) Regulations 2020 came into force, transferring responsibilities for the regulation of food supplements from EU organisations involved in the risk assessment and risk management processes to appropriate authorities and bodies in GB and reflecting the Protocol on Ireland/Northern Ireland.

There is often a blurred line as to the classification of certain nutritional supplements and whether they should be classified as a food product or a medicinal product. For example, a “nutraceutical” is a product that contains substances and/or chemicals that can claim to improve certain health conditions or prevent illness or disease. The classification of these products will depend on the composition of the product, its presentation and how it is labelled. See 1.5 Borderline Products for further details.

GMOs

The introduction of the Genetically Modified Organisms (Deliberate Release) (Amendments) (England) Regulations 2022 will enable products containing GMOs that could have occurred naturally or through traditional methods, to be released for non-marketing purposes. This will enable the UK’s bioscience sector to develop new products without some regulatory restrictions.

Pharmaceuticals

The Human Medicines Regulations 2012 (SI 2012 /1916) apply to medicinal products for human use and provide a regime for:

• the authorisation of such products;
• the manufacture, import, distribution, sale, and supply of such products;
• labelling and advertising; and
• pharmacovigilance.

Blood products

Blood products are considered as human medicine and are therefore subject to the Human Medicines Regulations 2012, as set out above. However, blood products must also comply with the quality and safety standards set out in the Blood Safety and Quality Regulations 2005.

Psychedelics

The use and possession of most psychedelics in the UK (including psilocybin, MDMA, LSD, and DMT) is restricted as they are currently classified as “Schedule 1” substances, which means that they are defined as illicit drugs under the Misuse of Drugs Regulations 2001. An exception is ketamine, which is classified as a “Schedule 2” substance. However, with attitudes changing towards the use of psychedelics, there have been growing calls for their re-classification.

Cannabis-Based Products for Medicinal Use (CBPMs)

The legalisation of CBPMs in the UK resulted from the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales, and Scotland Regulations) 2018 (“the 2018 Regulations”). Since the 2018 Regulations were implemented, further guidelines and recommendations have been published. In March 2020, the MHRA updated its guidance to specifically address cannabidiol (CBD) products, setting out its position on the classification of CBD products and the supply of CBPMs. In November 2020, the Advisory Council on the Misuse of Drugs recommended that it should be commissioned to assess the impact of the rescheduling of CBPMs over two years as there is not yet sufficient evidence available to fully assess any and all consequences of the 2018 legislative change. It also recommended that the UK government should review international legislation facilitating the use of CBPMs.

The government proposed a new Medical Cannabis (Access) Bill in 2021 which aims to facilitate patient access to CBPMs more readily on the NHS. The Bill never passed its second reading in the House of Commons.

Clinical Trials Regulation

The UK’s current clinical trials regime, provided for by the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), which is derived from the EU’s Clinical Trials Directive (2001/20/EC) (CTD), is set to be subject to reform.

Owing to the timing of Brexit, the EU’s Clinical Trials Regulation (EU 536/2015) and Clinical Trials Information System, which reformed the existing framework under the CTD, did not apply in the UK.

On 21 March 2023, the MHRA published its proposal to update the existing regulatory framework following a consultation in 2022. The MHRA has proposed a series of new measures to make it faster and easier to gain approval and to run clinical trials in the UK, representing the biggest overhaul in UK clinical trials regulation in over 20 years.

The current product safety regimes have been criticised for their alleged inability to deal with newer technologies. It is therefore likely that these product categories will receive additional attention in the near future, in the form of either revised laws and/or increased guidance on the application of legislation as it currently stands. However, these newer technologies are currently contemplated in the existing regulatory frameworks outlined in 1.1 Medical Devices. Below are some specific examples.

Medical Apps, Telemedicine Apps, and Healthcare Wearables (Digital Health Products)

If a digital health product satisfies the definition of a medical device (ie, that its intended use is for diagnostic, treatment, prevention, or prognosis purposes), then the UK MDR 2002 is the applicable product safety legislation, as set out in 1.1 Medical Devices. On 17 October 2022, the MHRA published the “Software and AI as a Medical Device Change Programme Roadmap” which proposes a programme of reform to ensure that the UK’s future medical device regime is fit for purpose for software, including artificial intelligence, that may be incorporated into digital health products.

Stem cells

Research governing stem cell technologies are governed by a well-established regulatory framework through the Human Fertilisation and Embryology Authority (HFEA). Regulatory oversight is also provided by the MHRA, the Human Tissue Authority, and the HFEA.

The determination of which regulatory regime applies to a certain product is fundamental to understanding the nature of the legal obligations that must be complied with. A singular regime or several regimes can apply to one particular product, and careful case-by-case analysis and expert input are often required to determine the applicability of a product safety regime to a product.

Some examples of common borderline product categories follow.

Medicines and Medical Devices

Decisions about whether a product is a medical device are based on the intended purpose of the product and its mode of action (what it is, what it does, and how it does it).

If the product is a medical device, the principal intended action must primarily be fulfilled by physical or mechanical means. It may not act principally by pharmacological, metabolic, or immunological means, although ancillary action is permitted. This mode of action is the main difference between medicinal products and medical devices, both of which have medical purposes.

Not all items used in a health, care, or hospital setting are considered to be medical devices.

The MHRA usually decides whether a product is a medical device when the manufacturer is not sure if their product is a medical device and approaches the MHRA for advice.

The MHRA may also review products when a complaint is received that a product is being marketed as a medical device and does not meet the regulations, or when a product claims to be a medical device but does not meet the criteria for it to be a medical device. The MHRA looks at:

• the intended purpose of the product, including the claims about what the product is and what it does (explicit and implicit);
• the mode of action of the product (ie, how it works);
• whether there are any similar products on the market and how they are regulated; and
• how the product is presented to the public through labelling, packaging, promotional literature and advertisements, including websites.

In accordance with guidance issued by the MHRA in January 2021 titled “Borderlines between medical devices and medicinal products in Great Britain”, where there is any doubt over whether the medicines or medical device regulations will apply, taking into account all of the characteristics of a product, the medicines regulations will apply.

PPE and Medical Devices

As noted in 1.1 Medical Devices, whether an item is a medical device or falls under the PPE regulations will largely depend on the use of the product and its function to primarily protect either the user or the public.

Cosmetics, Biocides, and Medicines

Hand gels and sanitisers may be a cosmetic, a biocide, or even a medicine. For such borderline products, the decision on classification must be taken on a case-by-case basis and will depend on the product’s primary function, presentation, and claims.

• If the function of the product is to clean and/or moisturise hands whilst providing a secondary antimicrobial effect, then the product can be classed as a cosmetic.
• If the sole purpose of the product is to kill germs, disinfect or sanitise hands, or prevent cross-contamination, then the product is a biocide.
• If a product is presented as principally preventing or treating a disease or adverse condition, it would be classed as a medicine; if a product explicitly says it is intended to prevent against specific viruses, such as COVID-19, flu or cold bugs, or other named germs, it is a medicine.

Certain requirements in relation to the manufacturing and design of medical devices and consumer health products are contained within the applicable UK regimes outlined in 1.1 Medical Devices. Such obligations are specific to these product categories, and are generally not a feature of less regulated or general consumer products. The prescriptive requirements to meet the general obligations within regulations are generally set out in technical standards, as follows.

Medical Devices and Related Products

Quality management systems

BS EN ISO 13485:2016, a standalone quality management standard derived from the internationally recognised and accepted ISO 9000 quality management standard series, is a harmonised standard under the UK regulations. It sets out the quality management system requirements in medical device design and manufacturing, which include the following:

• documentation requirements for design, development, verification, validation, traceability, and personnel competence; and
• product-specific requirements and records in respect of performance, usability, safety, functionality, applicable regulatory standards, risk management and other details.

Consumer Health Products

Cosmetics

For cosmetics, manufacturers need to follow good manufacturing practice (GMP).

GMP is a collection of hands-on advice referring to all activities that can affect the quality – and therefore safety – of the final product. It includes operational rules and also organisational guidelines for the production, control, storage, and shipment of cosmetic products. It states the general requirements for manufacturers of cosmetic end products relating to the equipment, production facilities, inputs, control of hygiene, and production, as well as hygiene requirements for personnel, laboratory control, labelling, monitoring of complaints, and product recalls.

The GMP ISO 22716 is a general guideline for manufacturers to develop their own internal quality management system and procedures. Key elements of ISO 22716 include:

• personnel and training;
• premises;
• equipment;
• raw materials and packaging;
• production/manufacturing;
• finished product;
• quality control and sample retention;
• waste;
• subcontract operations;
• deviations;
• complaints and recall;
• change control;
• internal audit (continuous improvement); and
• documentation.

Several obligations relating to corporate social responsibility, the environment, and sustainability are applicable throughout the life cycle of a product are contained within product safety legislation but also in discrete pieces of legislation. Examples include the following.

• Sourcing – through several pieces of consumer electronics and general chemicals legislation, which have an impact on medical device and consumer health products, there is a prohibition on using the most harmful chemicals in consumer products unless it is essential for society in general, and an obligation to register certain substances used in the products.
• Labour use – commercial organisations carrying out all or part of a business in the UK with a total annual turnover of GBP36 million or more must publish a modern slavery statement detailing the steps taken by the business to ensure that slavery and human trafficking are not taking place in its business or supply chains.
• Manufacturing processes – suppliers to the NHS will be impacted by the NHS Net Zero/NHS Carbon Footprint Plus goal to reduce the NHS’s emissions by 80% in 2036–39 and reach net zero emission in the future.
• Decommissioning stage – through several pieces of legislation that target consumer electronics but have some application to medical devices and consumer health products, there are ongoing obligations on manufacturers to make products recyclable at the end of their life cycle and to minimise the impact/damage on the environment. However, the legislation governing recycling may not be appropriate for certain medical devices or single use plastics. Although there are provisions to allow legislatures to make separate legislation on these products, no such laws have yet been created.
• Waste disposal – there are requirements, again largely targeting consumer electronics, that have some application to medical devices and consumer health products, but also fit-for-purpose legislation that requires decontamination before the disposal or transfer of used products to a third party; manufacturers and importers of products containing certain metals (like mercury above 3%) and certain batteries have special disposal obligations.
• The refurbishment of products is regulated, and a product supplied to a new owner must have a necessary marking and otherwise be compliant with mainstay product safety regulations.
• Right to repair – the Right to Repair Regulations introduced in July 2021 seek to tackle waste by obliging manufacturers to make spare parts available for certain white goods within two years of launching a new model. Spare parts must remain available for ten years.

The making of product claims has been a focus of regulators for some time, on the basis that the messaging given to consumers substantially impacts their purchase decisions and therefore has the potential to mislead. Product claims are often the basis for the determination of what product safety regime applies, as discussed in 1.5 Borderline Products, so is also important on that basis.

The nature of these regulations pertains, generally, to the characteristics of the product, including any environmental claims.

Some relevant rules around product marketing in the UK are as follows.

Medical Devices

In the UK, manufacturers can advertise medical devices directly to patients as long as, inter alia, the adverts are not misleading, do not encourage patients to excessively use a device and do not falsely claim that a device can cure an illness. Adverts must be accurate, balanced, objective and unambiguous; they must be honest and not misleading.

They can also advertise directly to healthcare professionals, as long as the adverts meet the same criteria including honestly, balance, and objectivity.

Adverts must make it clear that they are adverts, and manufacturers are allowed to compare different products.

Medicines

Rules applying to marketing communications are regulated by health regulators such as the MHRA, the Veterinary Medicines Directorate, the European Medicines Agency, and the Department of Health. Marketing communications for those products must comply with the rules and professional codes of conduct of the relevant professional bodies.

Some key requirements for the marketing of these types of products are as follows:

• they must not provide a diagnosis or suggest a treatment by correspondence, for instance, by post, by email, or by other means of an electronic communications network;
• those offering individual treatments, especially physically invasive treatments, may be asked by the media and the Advertising Standards Authority to provide full details together with information about those who supervise and administer them – practitioners must have relevant and recognised qualifications;
• they must not confuse consumers by using unfamiliar scientific words for common conditions;
• marketers inviting consumers to diagnose their minor ailments must not make claims that might lead to a mistaken diagnosis;
• they must not falsely claim that a product is able to cure illness, dysfunction, or malformations;
• references to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated – unqualified claims such as “cure” and “rejuvenation” are not generally acceptable, especially for cosmetic products;
• they must hold proof before claiming or implying that a minor addiction or a bad habit can be treated without effort from those suffering;
• they must not encourage consumers to use a product to excess, and must hold proof before suggesting their product or therapy is guaranteed to work, is absolutely safe, or is without side effects; and
• they must not suggest that any product is safe or effective merely because it is “natural” or that it is generally safer because it omits an ingredient in common use.

Manufacturers must be alive to the risks of “greenwashing”, being the practice of making unsubstantiated or misleading environmental claims. In the UK, there is currently no legislation governing the practice of “greenwashing” although guidance has been issued, including the Green Claims Code published by the Competition and Markets Authority in September 2021.

Pre-marketing obligations are mainstay requirements under UK product safety laws. These obligations can be multifaceted in nature, requiring companies to:

• perform safety assessments on their products to ensure compliance with mainstay product safety requirements (with or without the involvement of independent third-party testing bodies);
• obtain pre-approval or at least notify regulatory authorities about the existence of a new compliant product on the market; and
• place requisite compliance marking on products to allow users to easily identify compliant products.

Some examples of pre-marketing requirements are set out below.

Medical Devices and Related Products

Conformity assessment procedures

Under the UK medical devices regulations, conformity assessments of varying natures are required for medical devices of different classes. This can be done by way of self-assessment or otherwise requires the involvement of third-party testing bodies or conformity assessment bodies.

The general safety and performance requirements applicable to medical devices under the regulations are as follows:

• the benefits must outweigh the risks and achieve the claimed performance – this must be proven with supporting clinical evidence and investigation;
• requirements regarding the chemical, physical, and biological properties for medical devices – devices are to be designed and manufactured in such a way so as to ensure that the characteristics and performance requirements referred to in Chapter I of the regulations are fulfilled, with particular focus on a number of factors, including the choice of materials and substances used, their compatibility, and the impact of processes on material properties;
• performance characteristics for in vitro diagnostic medical devices; and
• information supplied by the manufacturer with the device (eg, instructions for use) – it is important that devices are labelled correctly.

Compliance marking

Manufacturers can place a CE mark on the product to show that the medical device has met the requirements when it has passed the conformity assessment. The government has implemented legislation that extends the time that CE-marked medical devices may be placed on the GB market beyond June 2023, with certain devices to be accepted until 2028 or 2030, depending on the type of device and certificates issued by EU-recognised notified bodies.

From 1 July 2023, the UKCA mark will be required in order to place a device on the UK market. Products will therefore have to comply with UKCA marking requirements from that point onwards, although manufacturers can voluntarily use the mark at this stage.

Registration with regulators

Manufacturers wishing to place a device on the GB market also need to register these devices with the  MHRA. Manufacturers must comply with the relevant product marking and conformity assessment requirements for medical devices, including IVDs, to do so.

UK responsible person

Where a manufacturer is not established in the UK, they must appoint a UK responsible person to register and act on their behalf to satisfy all product regulation and safety requirements. The following labelling requirements apply:

• the name and address of the UK responsible person, where applicable, must be included on product labelling where the UKCA mark has been affixed; and
• the UK responsible person’s details do not need to be included on labelling for CE-marked devices.

Commercial incentives are the main drivers behind the internationalisation efforts of global companies.

However, Brexit is likely to substantially change companies’ behaviours in respect of doing business, and making products available, in the CB and EU markets. Given the duplication of requirements between the UK and EU, which are divergent in many ways (particularly in respect of medical devices where, immediately post-Brexit, UK and EU positions have begun to vary greatly), companies may consider whether they wish to be in both markets.

Whilst some may view the duplication of requirements as a prohibitive factor to entering the EU, in many ways the distinction between the two markets may present an opportunity. The UK has already taken advantage of its moving away from the EU legislative regime, having already undertaken significant reform of formerly EU-based legislation (see 5.2 Legislative Reform and the UK Trends and Developments chapter in this guide for more detail).

For example, the UK government has recently undertaken the following actions to reform the applicable safety regimes:

• consultation organised by the Office for Product Safety and Standards (OPSS) in March 2021 to modernise product safety laws;
• the potential review and reform of the Consumer Protection Act of 1987;
• a review by the Department for Environment, Food & Rural Affairs of genetically modified organisms (GMOs) legislation in terms of narrowing the definition of products that fall under GMO-specific regimes in the UK;
• published response by the MHRA on the future regulation of medical devices following a consultation in 2021 (see 1.1 Medical Devices); and
• proposed review and reform of UK REACH.

There is no doubt that the UK’s product safety regime will be amended in the mid- to long-term in order to reflect a post-Brexit position and to reflect the UK’s unique viewpoint on certain product categories and technologies.

Post-marketing obligations are another mainstay facet of the UK’s product safety regime. Such obligations are aimed at ensuring that products remain compliant and safe whenever they are available to end users, and continue to attach for a substantial portion or the entire life of a product in circulation within the UK market. The system imposes prescriptive requirements on entities within the supply chain to monitor whether said obligations are met, and to liaise with authorities to confirm it. It also requires action to be taken where a product fails to adhere to the mandatory requirements, or otherwise presents safety risks, in terms of reports to authorities and also in terms of taking action in the market or supply chain to reduce this risk, including by performing a product recall in certain circumstances.

Examples of post-marketing obligations are as follows.

Medical Devices and Related Products

Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device. They must also take appropriate safety action when required. The manufacturer must ensure their device meets appropriate standards of safety and performance for as long as it is in use.

The notification and evaluation of adverse incidents and field safety corrective actions (FSCAs) involving medical devices is known as the medical device vigilance system. Comprehensive information on the medical device vigilance system is given in MEDDEV 2.12/1 rev 8 and the additional guidance under Post-Market Surveillance, describing what, how, and when to report adverse incidents involving medical devices on the UK market. There are also prescriptive timeframes that apply, depending on the severity of the issue.

FSCAs are actions affecting devices that have already been distributed, which are taken by a manufacturer in order to reduce the risk of death or serious deterioration in health. It is the reason for the field action, not the type of field action, that decides whether it is reportable as an FSCA.

Consumer Health Products

Cosmetics

There are requirements to report both undesirable effects (UEs) and serious undesirable effects (SUEs).

The responsible person or distributor must report all incidences of SUEs to the Secretary of State. Information on any SUE should be notified to the OPSS, Trading Standards, or the relevant primary authority. The Secretary of State must immediately inform all other competent authorities of any information reported.

Notification should take place “without delay”. This is accepted in the UK to mean within 30 calendar days from when anyone in the company is informed of a possible SUE.

Where a distributor reports the SUE of a cosmetic product to the Secretary of State, the Secretary of State must immediately inform the responsible person.

Consumers or health professionals may also report SUEs of a cosmetic product. If they report the SUE to any competent authority that is not the Secretary of State, then that competent authority must immediately inform the Secretary of State, who must then immediately inform the responsible person. Where consumers or health professionals report SUEs to the Secretary of State, the Secretary of State must immediately inform all other competent authorities and the responsible person.

Food Supplements

As set out in 1.2 Healthcare Products, food supplements are regulated as foods by the food authorities and are subject to legislation governing food products that cross-refers to the Annex of EU Directive 2002/46/EC on rules for vitamins and minerals used in food supplements.

In the UK, the Nutrition (Amendment etc) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc) (EU Exit) Regulations 2020, which came into force on 1 January 2021, transferred responsibilities for the regulation of food supplements from EU organisations to the appropriate authorities and bodies in the UK.

The General Food Regulations 2004 and the Food Safety and Hygiene Regulations 2013 (which give effect to European Regulation (EC) 178/2002) contain requirements for extensive traceability systems throughout the supply chain.

Obligations to notify the Food Standards Agency (FSA) and the relevant local authority of unsafe food and drink products are governed by Regulation EC/178/2002 on General Food Law (Article 19) and the Food Safety and Hygiene Regulations 2013. A food business operator must notify the authorities if it considers or has reason to believe that food it has placed on the market may be injurious to health.

Several regulators oversee compliance with product safety rules in the UK. The hierarchal nature of the regulatory bodies that oversee this area, and in particular the existence of a body with oversight over systemic or more serious product safety issues, is a unique aspect of the UK system. Indeed, this layered approach to regulatory enforcement is the only one of its kind in Europe, and is more akin to the well-regarded mechanisms used in the USA.

The regulatory authorities relevant to the oversight of medical devices and consumer health products are as follows:

• local authorities are involved in general day-to-day enforcement of product safety rules through the Trading Standards offices; the Department for Business, Energy, and Industrial Strategy (BEIS) is in charge of general product safety regulation, assisted by the OPSS, and generally takes an interest in higher profile or more serious product safety issues, in liaison with Trading Standards as above; and
• there are also several authorities responsible for overseeing manufacturers’ compliance with the rules applicable to specific products, as detailed below.

Medical Devices

The MHRA is in charge of general market surveillance in the UK. It also covers the marketing and supply of medical devices to the UK.

Consumer Health Products

If consumer health products are considered medicinal products, they fall within the remit of the MHRA.

If they are not considered medicinal products, the following applies:

• cosmetics are supervised by the BEIS, the OPSS, and UK Trading Standards for enforcement and market surveillance; and
• food supplements are covered by the FSA.

New Products/Technologies and Digital Health

It should be noted that digital health products meet the medical device definition as provided by the Medical Devices Regulations of 2002, so the MHRA is in charge of ensuring manufacturers’ compliance.

CBD Products

CBD products with a medical purpose are regulated by the MHRA as well. However, consumable CBD falls within the remit of the FSA or the OPSS as part of the cosmetics regulatory regime.

Borderline Products

As discussed in 1.5 Borderline Products, one of the MHRA’s powers is to determine whether a product is a medical device or medicine. If it is a medical device, it will be regulated by the MHRA. Otherwise, it will depend on the most applicable regulatory regime as to which regulator responds to enforcement matters.

The regulators responsible for the oversight and enforcement of product safety regimes, as outlined in 3.1 Regulatory Authorities, have a wide range of powers, many of which overlap and are deployed in an escalating manner, responsive to the seriousness of the issue or lack of response from the companies being regulated.

Local Authorities/Trading Standards

These regulatory bodies may:

• issue recall/withdrawal notices and requirements to warn;
• issue product recall enforcement notices;
• issue statutory notices and cautions;
• enter and search premises;
• seize documents and goods;
• require information;
• test equipment;
• observe the carrying on of business;
• inspect products;
• seek the imposition of civil sanctions against manufacturers; and
• commence criminal prosecutions.

OPSS and BEIS

These regulatory bodies may:

• carry out inspections;
• test products and notify the results to the manufacturers (or the relevant representative);
• carry out documentary review and investigations;
• supervise market surveillance;
• agree sanctions with manufacturers;
• issue statutory notices;
• impose a financial penalty;
• institute criminal proceedings;
• refer a matter to another enforcement body for investigation or action; and
• publish enforcement actions taken against manufacturers.

MHRA

This is particularly relevant for medical devices, for those healthcare products that are considered medicinal products, for digital health products and for medical CBD.

The MHRA has a wide range of investigative, enforcement, and inspection powers, including the following:

• to investigate any business activity covered by the Medical Devices Regulations of 2002 and the General Product Safety Regulations of 2005;
• as part of its general role over market surveillance, to:
1. assess all allegations of non-compliance raised with it;
2. monitor the UK-approved bodies designated by the MHRA to assess manufacturers’ compliance with product safety provisions; and
3. investigate any medical device following the report of an adverse event or information indicating a potential issue with a medical device;
• to contact manufacturers about breaches of regulations and seek additional information from them;
• to issue a prohibition notice in order to ban the supply of any products that are considered unsafe and/or do not comply with the relevant regulations;
• to issue a notice to warn to manufacturers, thereby requiring them to issue a warning themselves and at their own expense about any product that is considered unsafe and/or does not comply with the relevant regulations;
• to forfeit orders for products when a safety provision has been breached;
• to issue a suspension notice to suspend the supply of any products for up to six months when it is suspected that a safety provision has not been complied with;
• to issue a notice to obtain information to help the MHRA decide whether a prohibition notice or a notice to warn is needed;
• to issue a compliance notice to ask manufacturers to correct a non-compliance;
• to issue a restriction notice to limit the availability of a particular product or class of products; and
• to issue a notice to require a supplier to organise the return of any products if it is considered that a dangerous one was supplied to consumers.

The MHRA also has a wide range of inspection powers, such as inspecting products and examining procedures.

FSA

The FSA has multiple enforcement powers to:

• bring prosecutions by application of the Food Standards Act of 1999;
• co-operate with local authorities like Trading Standards to investigation and prosecute offenders;
• carry out inspections;
• issue an improvement notice; and
• enter, search, and seize.

The product safety offences that exist for the product categories listed in 1. Applicable Product Safety Regulatory Regimes will depend upon the applicable regulatory regimes.

The GPSR provide the requirements for all consumer products that are not governed by more specific regimes. Under the GPSR, it is an enforceable offence for a producer or distributor to sell or place on the market a product that is not safe or that they know or should have presumed to be an unsafe product based upon the information in their possession. The penalty for such offences under the GPSR is up to 12 months imprisonment and/or a fine.

Failure to report to authorities under Section 20(3) of the GPSR is also an offence, punishable with an unlimited fine or imprisonment for a term not exceeding three months.

For medicinal products and medical devices, failure to comply with the MDR or the conditions of a notice issued by the MHRA may result in an offence. Prosecution under the MDR could carry a penalty of an unlimited fine and/or six months’ imprisonment.

There are three main mechanisms/causes of action that can typically be employed by claimants pursuing product liability claims in the UK in respect of the product categories listed in 1. Applicable Product Safety Regulatory Regimes:

• strict liability under the Consumer Protection Act 1987;
• tortious liability – negligence; and
• breach of contract – express or implied statutory term.

Claimants often elect to pursue more than one of the causes of action in parallel, in respect of the same facts, to increase the likelihood of success and overcome some of the limitations of certain causes of action.

“Strict Liability” Statutory Regime Under the Consumer Protection Act 1987 (CPA)

The CPA is the UK legislation that implemented the EU Product Liability Directive 85/374/EEC into UK law. The CPA creates a no-fault liability scheme in respect of defective products that have caused personal injury or damage to private property.

Under the regime, the manufacturer, importer, and distributor/supplier have joint and several liability.

Tortious Liability – Negligence

Manufacturers or other actors in the supply chain (mostly where a manufacturer cannot be identified) can be liable in common law negligence if a claimant can prove, on the balance of probabilities, that:

• the defendant owed the claimant a duty of care;
• the defendant breached that duty of care;
• the breach caused the claimant’s loss or damage; and
• the loss was reasonably foreseeable.

Breach of Contract – Express or Implied Statutory Term

Consumers that are party to a contract with a seller or supplier of products can pursue a breach of contract claim if a product supplied is defective or otherwise fails to conform to the contract of sale.

The seller may be exposed in respect of a breach of either express terms or those implied by the Consumer Rights Act 2015 in respect of:

• the fitness for purpose of the product;
• it being as described; and
• it being of satisfactory quality.

To bring a claim in contract, a claimant must prove the following, on the balance of probabilities:

• a contract is in place – ie:
1. there is a mutual intention to create a contract;
2. an offer has been made;
3. that offer has been accepted; and
4. there has been “consideration” (value) exchanged between the parties;
• the contract has been breached; and
• the breach of contract has led to loss.

In the EU, legislators are progressing with reform of the PLD to respond to the challenges and risks presented by new technologies and the circular economy. Similar reform was considered by the UK’s Law Commission, with it having consulted on proposals to make similar amendments to the CPA. However, it confirmed on 16 February 2023 that it does not intend to progress with any proposals for reform for the time being.

Prior to Brexit, the jurisdiction of UK courts, as opposed to other EU member state courts, was determined by the operation of EU-level laws. The post-Brexit situation is set out below.

CPA

Generally, like other European-based courts, UK courts will assume jurisdiction to try a case where either the injury, loss or damage occurs, or where both parties are domiciled in that country.

Prior to the UK leaving the EU, where a defendant was domiciled in England, the English court had jurisdiction and could not decline jurisdiction, pursuant to Owusu v Jackson (Case C-281/02) [2005] ECR I-1383. Now that the UK has left the EU, this no longer applies and UK-domiciled defendants are able to challenge the English court’s jurisdiction on the grounds of it not being the appropriate forum.

Negligence

In order to invoke the jurisdiction of English courts in respect of negligence claims, it is sufficient for a defendant to be physically present in England and Wales to enable the claimant to serve proceedings on that defendant.

Contract

Contractual terms agreed by both parties ordinarily determine the applicable law, jurisdiction, and location of proceedings in respect of contractual breaches.

The general principle for the payment of costs in English law applies to product liability cases: the losing party pays the costs of the successful party (including fees, court fees, and disbursements containing expert fees).

The court can award costs on two bases.

• Standard basis, under CPR 44.3(2) – where the court will only award costs that are considered to be both reasonably and necessarily incurred by the party seeking recovery. Any costs considered to be disproportionate may be disallowed or reduced.
• Indemnity basis, under CPR 44.3(1)(b) – where the court orders costs to be assessed on an indemnity basis, costs need not be incurred by necessity and there is no requirement for costs to be proportionate to the issue in dispute. Essentially, a party that has an indemnity costs order made in their favour is more likely to recover a sum that reflects the actual costs incurred in the proceedings.

In product liability claims involving damages for personal injury or death, the regime of qualified one-way costs shifting (QOCS) applies. In practice, this means that, in most claims where a claimant is unsuccessful, the claimant will not be responsible for the defendant’s costs. However, the QOCS provisions may not apply if the claim is struck out, or if the court determines that the claimant was fundamentally dishonest. If the claimant’s claim is successful, they may recover their costs from the defendant, subject to a “set-off” of any (interlocutory) costs orders made in the defendant’s favour. Recent changes to the QOCS regime provides that for claims issued after 6 April 2023, costs orders made against a claimant will be enforceable against any orders for damages, costs, and interest made in favour of the claimant.

Costs are subject to a formal assessment procedure if they are not or cannot be agreed between the parties.

However, the court has wide discretion to vary any of the above general positions regarding costs.

Part 36 Offer

Part 36 is a provision in the Civil Procedure Rules (CPR) designed to encourage parties to settle disputes and avoid going to trial. Under Part 36, both the claimant and the defendant can inform the other side what they will accept or offer to resolve a dispute.

A Part 36 offer is an offer in relation to damages only (not costs), made strictly in accordance with Part 36 of the CPR. Once made, it can only be withdrawn within the “relevant period” (of at least 21 days) with leave of the court. Therefore, if a crucial piece of evidence is received during the “relevant period” that radically alters the value of the claim, it is unlikely this will be considered to be a sufficient change in circumstances to allow the offer to be withdrawn.

A Part 36 offer can be withdrawn after the “relevant period” has expired. If an offer has not been expressly withdrawn, it will remain open for acceptance, even if it has previously been rejected.

Calderbank

As an alternative to making a Part 36 offer, it is possible to make a “Calderbank” (or Part 44.3) offer. This is a contractual offer that is expressed to be “without prejudice save as to costs”. A Calderbank offer has some advantages over Part 36 offers in that it can be withdrawn at any time and can include an offer in relation to costs. It can also include contractual terms as may be appropriate, such as a clause by which the parties agree to keep the fact of settlement confidential. Such an offer may still be relevant to costs, as it is an attempt to settle the claim, but does not always achieve the same certainty as a proper use of the Part 36 regime.

Those involved in litigation should be fully alert to the importance of appropriate and timely offers as an important means by which to achieve settlement and, where the case does not settle, to provide costs protection.

Other mechanisms are available in respect of product-related contentious matters.

Judicial Review of the MHRA

The decisions of the MHRA in respect of medical products and medical devices can be challenged by way of judicial review in the Administrative Court, Queen’s Bench Division. An application should be made promptly and in any event within three months of the decision to be challenged. The applicant must be able to show a sufficient interest in the matter to which the application relates, and the court’s permission is required to proceed with a claim for judicial review. The general grounds for judicial review include:

• irrationality;
• illegality;
• procedural unfairness; and
• legitimate expectation.

Inquests

Where the circumstances of a death are not clear and are potentially or allegedly related to a healthcare product, a Coroner’s Inquest may be held. A Coroner’s Inquest is a hearing that in all but exceptional circumstances is held in a public court. At this hearing, the Coroner will call relevant witnesses to give evidence about how the deceased died. A Coroner’s investigation is entirely separate from any civil or criminal proceedings that may arise out of a death, and a Coroner is expressly prohibited from making findings that determine questions of civil or criminal liability. However, the evidence a Coroner will obtain as part of their investigation and the conclusions that are reached as to how the deceased came by their death are frequently relevant to any civil proceedings that may arise from the circumstances of the death.

Public Inquiries

Independent public statutory inquiries may be set up to investigate the history, safety, and impact of healthcare products in the UK. A recent prominent example is that of the Infected Blood Inquiry established in 2018 to examine the circumstances in which men, women, and children treated by the National Health Service in the UK were allegedly given infected blood and infected blood products, in particular since 1970.

More recently, the UK COVID-19 Inquiry has been set up to examine the UK’s response to and impact of the COVID-19 pandemic, and to learn lessons for the future. The Inquiry recently received its final Terms of Reference, which set the topics for the Inquiry’s investigations into the UK’s response to the pandemic. These include the public health response across the whole of the UK, the response of the UK’s health and care sector, the economic response to the pandemic, including governmental interventions, and identifying the lessons to be learnt in order to inform preparation for future pandemics across the UK.

There are two main formal mechanisms in respect of group actions brought in the courts in England and Wales, as set out below.

Formal Mechanisms

Group litigation orders (GLOs)

Under CPR 19 Section III, a GLO allows the management of multiple claims that give rise to common or similar issues of fact or law. Claimants to these actions must “opt in”. In the process of GLO proceedings, there will be a trial of issues that are common to all underlying claims. Lead cases that are considered the most appropriate can be chosen and are used to allow the parties to put common issues into context. Decisions made in respect of these lead cases are binding on all parties to the GLO. This is the most commonly used formal mechanism in respect of product liability claims.

Representative actions

Under CPR 19 Section II, representative actions can be brought by one or more claimants (the qualified representative entity) on behalf of a group considered to have the “same interest”. The representative action regime operates on an “opt-out” basis, meaning that the action is brought on behalf of those persons who fall within the class, unless they express their wish not to be represented.

The UK Supreme Court (UKSC) judgment in Lloyd v Google LLC [2021] UKSC 50 provided clarity on the interpretation of the “same interest” requirement in the context of a large-scale data privacy action. In this action, the UKSC held that, to bring a claim for compensatory damages for a breach of the Data Protection Act 1998, a claimant must establish that there has been a breach, and that damage has been suffered as a result, in the form of material damage or distress. As this would involve an assessment of individual damages and loss, the claim could not proceed as a representative action under CPR 19.6 as the “same interest” requirement had not been met.

In cases requiring an individual assessment of damages, the UKSC suggested that the representative action procedure could still be used to determine common issues of fact or law, leaving issues that require individual determination to be dealt with subsequently.

However, it is possible that the courts may be willing to take a more flexible approach, as indicated by the High Court’s recent decision in Commission Recovery Ltd v Marks & Clerk [2023] EWHC 398 (Comm).

Representative actions operate on an “opt-out” basis, such that all group members will automatically be included in the group and represented in the action, and a judgment will be binding on all those represented unless they expressly state that they wish to be excluded. Such actions are rare, although there are signs they may become more widely used.

In addition to these mechanisms available in the courts, an opt-out collective proceedings regime has been available for claimants to bring private competition claims at the Competition Appeals Tribunal, as established by the Consumer Rights Act 2015. The first collective proceedings order (CPO) was granted in the case of Merricks v Mastercard [1266/7/7/16] in August 2021 and several others have been granted since.

For more information on this topic, please see the UK chapter of the Chambers Collective Redress and Class Actions Guide.

ADR offers a bespoke way of resolving disputes that are not resolvable through the litigation or arbitration process. ADR often includes the mediation of an existing dispute case, evaluation, adjudication, and expert determination.

The breach of product safety regulations and their requirements may be of evidential value in supporting product liability claims.

Following several related initiatives, the UK government has consulted on waste prevention proposals for products in the “Waste Prevention Programme for England: Towards a Resource Efficient Economy”. The consultation closed on 10 June 2021 and feedback continues to be analysed. This UK-led initiative mirrors a parallel EU initiative of a similar nature called the Sustainable Products Initiative, and addresses topics such as:

• end of life;
• repair, reuse, and remanufacturing; and
• extended producer responsibility.

The consultation focuses on construction products, textiles, furniture, electronics, vehicles, food, and plastic packaging. Such measures are expected to eventually impact related products in the future.

In a post-Brexit era, the UK government has also consulted on reforming competition and consumer policy in relation to a wide-ranging reform programme to drive enterprise, innovation, productivity, and growth.

Wide-ranging legislative reform is currently in progress regarding product liability and safety in the UK in respect of the products listed in 1. Applicable Product Safety Regulatory Regimes. Further detail is outlined in the UK Trends and Developments chapter in this guide.

Product Safety Law

In March 2021, the UK government announced its plans to review and strengthen the UK’s current product safety laws to ensure they are fit to deal with emerging innovations and technologies. The UK Product Safety Review Consultation – “Modernising Product Safety Laws to Ensure they are fit for the 21st Century” – focuses primarily on product safety and covers consumer products such as toys, electrical equipment, and cosmetics, but excludes medical and healthcare products, food products, vehicles, chemicals, and construction products. The results of the review were published by the OPSS in November 2023. Any hard or soft laws created on the basis of the results of the review would mark a significant development in UK product safety laws, which are more than 30 years old.

Also of note are the MHRA roadmap for the delivery of the future framework for medical devices and the draft statutory instrument on Post-Market Surveillance (see 1.1 Medical Devices). It remains to be seen what the election of a new Labour government in July 2024 will mean for healthcare and medical device regulation in the UK.

These reviews are in parallel to a similar review being held at EU level (as discussed in the EU Law and Practice chapter of the Product Liability and Safety Global Practice Guide), which has been ongoing for several years, including by two European Commission expert groups. The positions taken by the EU and UK after each respective review could result in a departure of the two sets of product safety and product liability laws and further onerous requirements for companies operating in both markets.

Connected Products and Cybersecurity

In April 2021, the UK government published a policy paper providing an overview of the government’s updated intentions for proposed legislation to regulate the cybersecurity of connected consumer products. The government’s aim is to implement a new robust scheme of regulation to protect consumers from insecure connected products, and mandating base requirements and disclosures for those selling such products.

The UK government also launched its National Cyber Strategy in January 2022, setting out its plan to protect its citizens in cyberspace, including by implementing the Product Security and Telecommunications Infrastructure Act (which received Royal Assent in December 2022) to enable the enforcement of minimum security standards in all new connectable products sold in the UK.

AI has dramatically enhanced the capabilities of medical devices in recent years. From diagnostics to improving manufacturing efficiency to robotics, the use of AI in this field is far reaching and continues to develop at pace.

The impact of AI on the industry has been recognised, with software now constituting a medical device in its own right, known as “software as a medical device” (SaMD). In March 2023, the MHRA published guidance on defining the intended purpose for SaMD to help manufacturers in meeting their statutory obligations. This followed the publication of the MHRA’s “Software and AI as a Medical Device Change Programme”.

The UK government is not currently proposing to regulate AI. On 29 March 2023, the Department for Science, Innovation, and Technology (DSIT) published its White Paper on AI, stating that it will be establishing a pro-innovation approach to AI.

The White Paper sets out five core principles including safety, transparency, fairness, and accountability, to be issued on a non-statutory basis and implemented by existing regulators who will be able to provide guidance on the development and use of AI in their respective sectors. It is proposed that the regime will regulate the use of AI, not the technology itself, so as to avoid barriers to innovation. The UK does not intend to assign rules or risk levels to entire sectors or technologies; rather, regulation will be based on the outcomes AI is likely to generate in particular applications. The White Paper accounts for the fact that some AI outcomes may require a higher standard of human-interpretability (the degree to which a human can readily understand the reasoning behind predictions and decisions made by the AI model), depending on the risks represented by an application. This is recognised by the MHRA’s Project Glass Box, which is addressing the challenge of setting medical device requirements that take into account adequate consideration of human interpretability and its consequences for the safety and effectiveness for AI used in medical devices.