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:
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:
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 requirement have effect.
Generally, these regimes have the following core features:
Overview of Specific Regimes
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 medical devices will continue to be accepted in England, Scotland and Wales (Great Britain – GB) until 30 June 2023. From 1 July 2023, all medical devices placed on the market in GB will be subject to new UK Conformity Assessed (UKCA) mark requirements.
On 11 February 2021, the Medicines and Medical Devices Bill became law as the Medicines and Medical Devices Act 2021 (the MMD Act). The MMD 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:
The Human Medicines Regulations 2012 (SI 2012 /1916) apply to medicinal products for human use and provide a regime for:
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.
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.
Medical instruments are generally considered as medical devices and are therefore subject to the UK MDR 2002, as referred to above.
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.
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:
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.
New independent chemical regulatory regimes have been introduced into the UK since the withdrawal from the EU, including:
Food and Nutrition Supplements
Food supplements are regulated by legislation applicable to each locale in the UK, as follows:
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 1.4 Borderline Products for further details.
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.
Cannabis-Based Products for Medicinal Use (CBPMs)
The legalisation of CBPMs in the UK was as a result of 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 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 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 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:
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.
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:
Consumer Health Products
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:
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.
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 1.4 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.
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 of honestly, balance, objectivity, etc.
Adverts must make it clear that they are adverts, and manufacturers are allowed to compare different products.
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:
Pre-marketing obligations are mainstay requirements under UK product safety laws. These obligations can be multifaceted in nature, requiring companies to:
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:
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. Until 30 June 2023, the CE mark will continue to be recognised in the UK. CE-marked devices and certificates issued by EU-recognised notified bodies in accordance with applicable legislation (Directive 90/385/EEC, Directive 93/42/EEC, Directive 98/79/EC, Regulation 2017/745 and Regulation 2017/746) will continue to be accepted until 30 June 2023. 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:
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:
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
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.
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 Exist) 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:
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:
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 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.
As discussed in 1.4 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 many of which 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:
OPSS and BEIS
These regulatory bodies may:
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:
The MHRA also has a wide range of inspection powers, such as inspecting products and examining procedures.
Food Standards Agency
The FSA has multiple enforcement powers to:
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:
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 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:
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:
To bring a claim in contract, a claimant must prove the following, on the balance of probabilities:
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.
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)  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.
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.
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 including expert fees).
The court can award costs on two bases:
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.
Costs are subject to a formal assessment procedure if they are not or cannot be agreed between the parties.
The court has wide discretion to vary any of the above general positions regarding costs, however.
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.
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:
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.
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 National Health Services in the United Kingdom were allegedly given infected blood and infected blood products, in particular since 1970. Its final report is expected to be published in 2022 or 2023.
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.
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.
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  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.
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; a further eight CPOs 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:
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. 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.
In a similar vein, the potential review and reform of the CPA (the implementing legislation that transposed the EU Product Liability Directive 85/374/EEC into UK law) is being reviewed by the Law Commission of England and Wales as part of its 14th Programme of Law Reform, having invited views as to whether the CPA should be extended to cover all software and take account of tech developments. In April 2022, the Law Commission extended the timetable for finalising the programme of reform.
These reviews are in parallel to a similar review being held at EU level (as discussed in the EU Law and Practice Guide for Product Liability and Safety), 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 Bill to enable the enforcement of minimum security standards in all new connectable products sold in the UK.
The impact of the COVID-19 pandemic has resulted in an unprecedented demand for the rapid production of specific products, such as diagnostic tests, vaccines, treatments and PPE. The race to combat COVID-19 has also been a catalyst for various trends that could impact product safety and liability matters in relation to the products listed in 1. Applicable Product Safety Regulatory Regimes. These trends include:
Further detail is provided in the UK Trends and Developments chapter in this guide.
25 Fenchurch Avenue
+44 20 7667 9677
+44 20 7667 9777Sarah-Jane.Dobson@kennedyslaw.com www.kennedyslaw.com
Medical Devices and Consumer Health Products in the UK: A State of Flux
The UK’s medical device and consumer health products safety and liability regimes are in a state of flux. Consumer behaviours have changed significantly and new market drivers have been introduced, including as a result of new ways of living forced on people by the COVID-19 pandemic. There has also been legislative reform, and more significant reform is soon to follow – some of which has been brought about by Brexit but the rest of which is the result of long-held policy-based reform.
The above context makes it complex for even well-meaning companies, insurers, third parties, regulators and policy makers alike to navigate the rapidly changing legal framework. However, these times also bring with them great promise and opportunity for all stakeholders in the industry. Most recently, there has been record-breaking speed and innovation in industries, often borne out of necessity, and new product categories and technologies are emerging rapidly to address contemporary issues.
There are some discernible trends emerging in this evolving legal landscape. All those involved in these industries should be aware of these trends for future-proofing their businesses, in terms of minimisation of legal risks but also maximising the potential for their businesses and strategies to take advantage of opportunities.
New Technologies in Medical Devices and Medicines
For many years, the UK government has supported the UK medical devices and consumer health products industries with a view to securing the UK's position as a world leader in medical device technology, including granting incentives such as research and development (R&D) relief breaks to support companies that work on innovative projects in science and technology.
For example, there have been notable advances in 3D printing for use in the production of patient-specific models and some orthopaedic implants. Messenger RNAs (mRNA) technologies have also advanced through the development of COVID-19 vaccines. Although initiated in response to the COVID-19 pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA) has also signalled a move towards the use of AI and new technologies to monitor adverse event reporting. In November 2020, the MHRA awarded a GBP1.5 million tender to GenPact UK to process the expected volumes of adverse drug reactions to the COVID-19 vaccine stemming from the accelerated timelines for the development and testing of the vaccines and the potential for gaps in the product safety profile at the time of distribution.
In September 2021, the MHRA published guidance entitled "Software and AI as a Medical Device Change Programme", to ensure that medical device regulation is fit for purpose for software, including AI. In a report produced by the UK’s independent Regulatory Horizons Council on the regulation of medical devices in the UK, new technology has also been underlined as significant area of development for UK medical devices industry.
This focus on new technologies has been reflected in the UK government’s recent response, published on 26 June 2022, to the consultation held between September and November 2021 on the proposed changes to the UK’s medical devices regulatory framework. The response pledges to make the UK a focus for innovation. It also outlines the intention to proceed with the proposal to clarify the meaning and scope of the term "software" by adding a new definition of software to the UK medical device regulations as a "set of instructions that processes input data and creates output data."
Contemporary Food Manufacturing Practices
There have been significant policy initiatives around the development of new food products and manufacturing processes across the UK. This policy agenda is largely reflective of:
Application of genetic technologies to the food industry
The application of genetic technologies, including to food manufacturing and crop growing practices, was the subject of a public consultation by the UK’s Department for Environment Food and Rural Affairs (Defra), which completed a consultation about the regulation of genetic technologies in the UK. EU legislation controlling the use of GMOs was retained in the UK at the end of the Brexit transition period, requiring that all gene edited (GE) organisms be classified as GMOs, regardless of whether they could be produced by traditional breeding methods.
However, the basis of the consultation was Defra’s view that organisms produced by GE or other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods, and the exit from the EU gave the UK the opportunity to consult separately on the implications of technological advances for food and supplements. In this regard, the UK looks set to diverge from the EU following the introduction of draft legislation: the Genetically Modified Organisms (Deliberate Release) (Amendments) (England) Regulations 2022.
Genetic technologies is also a focus area of the UK’s independent Regulatory Horizons Council.
Restriction on use of CBD in food products in the UK
In addition to the existing medical uses for CBD and cannabis, their use in all forms of products is rising in the UK. The UK market is now flooded with CBD-containing cosmetics, foods and drinks, amongst other product categories.
Despite the UK’s exit from the EU, in February 2020 the Food Standards Agency (FSA) announced the deadline of 31 March 2021 for the CBD industry to comply with EU Regulation 2015/2283 relating to "novel foods", requiring such products to undergo safety assessments and obtain authorisation under the aforementioned EU regulation before being placed on the market. Without authorisation, products were required to be withdrawn from the market.
The novel food regulation has historically been subject to little enforcement, with prohibited products such as CBD flowers and unlicensed CBD foods or supplements still being sold on the market. This development therefore signals the introduction of much stricter enforcement processes for CBD-containing products. It is also rare for pre-existing product categories to have mass market withdrawal required, as the FSA did in March 2021.
As of May 2022, according to the FSA there are only approximately 69 products validly holding an authorisation in the UK under the mandated scheme. The FSA has emphasised that its enforcement policy will focus on those who have not shown "interest in moving towards compliance". There are other applications that the FSA has confirmed are moving well towards approval. Companies in this area should be conscious of these strict regulatory requirements, which are being actively monitored and enforced by the regulator.
Expansion and Evolution of Product Categories
There is a growing market for quasi-medical and borderline products in the UK, including but not limited to cosmetics, aromatherapy products containing oils or related aroma-chemicals, biocides, food supplements, sports supplements, topical anaesthetics, weight loss products and nitrous oxide. With these growing sectors comes a host of new product classification considerations and product safety assessments, which largely need to be assessed and decided on a case-by-case basis. Whilst the MHRA has issued guidance on how to classify products being placed within this growing market, the process is not without difficulty, and manufacturers should be aware of these issues when developing products that may fall within the confines of several product categories.
Responses to COVID-19 by UK Medical Device and Healthcare Regulators
The impact of the COVID-19 pandemic on the medical devices and healthcare industry has been unprecedented. In order to respond to the pandemic, unparalleled and extensive action was required from a variety of regulators and agencies. Regulators deployed a range of tools, with the following being some examples of the broad and varied nature of the actions.
The British government also extended indemnification to certain manufacturers of RMVS approved by the MHRA for relevant claims for product liability and for third party intellectual property violations.
As with similar practices in other jurisdictions, the above practices by regulators were wide-spread and considerable, but these changes are generally specific, defined and temporary in nature.
Long-term consideration of resultant product liability exposure is recommended in order to minimise the risk of exposure to fines or criminal sanctions that can attach to product liability claims or offences for breach of product safety regulations.
Following the pandemic, the MHRA has released a series of white papers that outline its ongoing regulatory strategy, which aims to incorporate some of the learnings from the COVID-19 pandemic.
Whilst counterfeiting has been a long-standing issue for all product categories, the COVID-19 pandemic saw criminal perpetrators focusing on the medical devices and consumer health product categories in an attempt to benefit from the increased focus and consumer activity in this area caused by the pandemic and the resultant changes in consumers' lifestyles. Some examples of products that were produced by counterfeiters and targeted by regulators during the pandemic include those comprising:
The pandemic has seen this issue shift from what was historically viewed as an IP risk to one more considered a product safety risk proper, and we can expect to see the relevant regulator’s attention shift accordingly.
Considerations for Corporate Social Responsibility and Environmental Issues
As an ongoing trend, policy changes and guidance issued in the UK in respect of the medical device and healthcare industries continue to focus on sustainability and environmental, social and governance ("ESG") considerations.
Greenwashing and environmental claims
With the proliferation of new product categories, particularly those targeted at the health or environmentally conscious consumer, the marketing and advertising aspects of those product categories have become heavily emphasised. Regulators and agencies have therefore been closely watching the use of product claims and associated advertising and marketing in these product categories – with a particular view to prevent consumers being misled by inaccurate or otherwise problematic claims. Cosmetic products have historically been particularly focused upon, with regulators, industry bodies and self-regulatory bodies (such as the Advertising Standards Agency – ASA) producing detailed guidance on the topic of claims, including "vegan", "organic", "natural", "not tested on animals" and "recyclable" in particular.
In September 2021, the UK Competition and Markets Authority (CMA) published draft guidance for businesses making "green" claims about their products. This followed an analysis of websites carried out by the CMA, alongside other national competition authorities, which found that 40% of green claims made online could be misleading.
The ASA has also made adverse decisions and taken action against a number of companies across a broad range of sectors, including medical and consumer health products, in respect of environmental claims – noting that claims regarding the recyclability of products must take account the full life cycle of the product.
Application of ESG compliance obligations
ESG-related obligations are increasingly becoming mainstay product compliance requirements in order to bring products to market. However, some of these broad-brush ESG product compliance requirements are not tailored to account for the specific features and risks of medical device and consumer health products, which are subject to their own more stringent, highly regulated regimes.
The recent ESG initiatives introduced in the UK include the Circular Economy Package 2020, which introduced a revised legislative framework in respect of wastage, identifying steps for the reduction of waste and establishing an ambitious long-term plan for waste management and recycling. A Plastic Packaging Tax was also introduced earlier this year. As of 1 April 2022, manufacturers or importers of plastic packaging products into the UK may be liable under Part 2 of the Finance Act 2021 to pay a tax on those products, known as PPT. The medical device and consumer health sectors will be impacted by this legislation.
Following the EU’s establishment of "the Right to Repair", as voted in by the EU Parliament in November 2020 with a view to saving costs for consumers and facilitating the development of a circular economy, the UK introduced the Ecodesign for Energy-Related Products and Energy Information Regulations 2021 in July 2021, sometimes referred to as "the Right to Repair Regulations", in order to tackle waste. This legislation obliges manufacturers to make spare parts available for dishwashers, washing machines, washer-dryers, dryers, fridges, freezers and televisions within two years of launching a new model. These spare parts must remain available for up to ten years. It also gives "professional repairers" access to spare parts and technical information.
These new legislative developments form part of a growing trend toward sustainable practices across industries and the demand for greater corporate responsibility by large-scale manufacturers, importers and suppliers. However, they are potentially problematic for the medical device and consumer health products industry, as the safety of such products is often contingent on the single use application of some or all components of the product.
The UK government’s consultation on the future regulation of medical devices notes that there are a number of ways in which the future regulatory regime for medical devices can improve and safeguard public health by driving more environmentally responsible manufacture, use and disposal. The government’s response to the consultation states that respondents had a high degree of interest in this topic of environmental sustainability, and that many commented that their products and practices are already subject to environmental regulation (eg, that of the REACH regime), cautioning the need to avoid duplicative requirements.
However, respondents also recognised the impact of climate change and that medical device regulation has a role in supporting the transition to a Net Zero economy. In light of this, the government will be considering publishing guidance on best practice to support alignment with government Net Zero Ambitions and the NHS Net Zero Supplier Roadmap.
Impact of Brexit on Medical Device Regulations and Regulators in the UK
Medical devices legislative framework
Medical devices is one area of law where the EU and UK had immediately divergent approaches post-Brexit. The EU adopted a new regime post-Brexit but, due to the timing thereof, the UK did not adopt this new framework but instead retained the laws that it had had previously (the older version of the EU-based regime, which the EU phased out in favour of the revised framework).
More specifically, the UK left the EU on 31 January 2020. Implemented in the UK by the European Union (Withdrawal Agreement) Act 2020, the Withdrawal Agreement provided for a transition period, ending on 31 December 2020, during which EU law continued to apply in the UK. Therefore, from 1 January 2021, excluding pre-existing EU-derived domestic legislation that continues to apply, the UK (excluding Northern Ireland) was no longer subject to EU single-market rules.
Currently, devices are regulated under:
These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Since 1 January 2021, all medical devices placed on the British market, including in vitro diagnostic medical devices (IVDs), need to be registered with the MHRA, with a grace period for registering the following:
The new EU Regulations on medical devices – Regulation (EU) 2017/745 on medical devices (EU MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR) – became applicable in the EU in May 2021, and the IVD regulations became applicable in May 2022, with the COVID-19 pandemic being cited as a reason for the delayed application.
The UK has several times foreshadowed the development of a new regime for itself, citing the departure from the EU and the divergent approach with the EU regime as an opportunity to consolidate its position as a world leader in medical device regulation. The following steps, among others, have been taken in shaping this new legislation that will be implemented.
In August 2021, the Regulatory Horizons Council made its report on medical devices regulation, with some key recommendations to be addressed in any new regulatory regime:
Between September and November 2021, the UK government consulted on the future regulation of medical devices in the UK. On 26 June 2022, the UK government published its response, in which it pledges to build the regulatory framework based on five pillars:
Impact on regulator
As a result of Brexit, a restructuring of the MHRA is anticipated, possibly leading to a reduction of its workforce by up to 20%. The agency has noted that a substantial loss in funding, normally obtained from the European regulatory system, will reshape the way in which it operates. Not only will this require an efficient use of operating costs, but the MHRA will also focus on redeploying and training staff in new areas of regulation and science. These challenges are all expressly acknowledged and addressed in the MHRA’s future strategy plan. It is also evident that the UK regulator will seek international collaboration further afield post-Brexit.
25 Fenchurch Avenue
+44 20 7667 9677
+44 20 7667 9777Sarah-Jane.Dobson@kennedyslaw.com www.kennedyslaw.com