Medical Devices & Consumer Health Products 2021

Last Updated August 31, 2021

UK

Law and Practice

Authors



Kennedys is a global law firm with particular expertise in litigation and dispute resolution, especially in defending insurance and liability claims. It has 66 offices, associations and co-operations across the UK and Europe, the Americas, Asia Pacific and the Middle East. The firm has a market-leading team handling product safety and regulation, large-scale product liability, recall and "mass tort" litigation and international claims. The core team is comprised of nine partners in London supported by more than 40 associates, as well as many of partners and colleagues across Kennedys' international offices. A number of the firm's lawyers have requalified in the law following careers in relevant industries (such as engineering, construction and medicine), which broadens its expertise for clients’ benefit. Kennedys acts for parties across various industries and has gained in-depth expertise in high-profile and complex matters involving a wide range of products, including automotive, chemicals, pharmaceuticals, medical devices, healthcare products and consumer goods.

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, either due to necessity or policy-driven departures in the wake of Brexit, UK-specific laws have become more prevalent as more time has passed since UK’s departure from the EU.

Overall, the UK product safety regime is multi-faceted and involves the operation of several layers of laws, which are designed ultimately 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

These, given their comprehensive nature, operate independently from any other product safety legislation, for products recognised to have unique risks. Relevantly 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. Relevant to medical devices and health products are the following sector-specific laws:

  • biocides;
  • cosmetics;
  • chemicals; and
  • personal protective equipment.

General product safety regime

This mandates 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 has effect.

Generally, these regimes have the following core features:

  • application of correct product safety regime (see 1.4 Borderline Products);
  • mandatory pre-marketing steps, including product safety assessments (see 2.4 Marketing and Sales); 
  • involvement of third-party bodies to determine compliance with technical standards, as a basis for a presumption the product meets safety requirements (see 2.4 Marketing and Sales);
  • record-keeping requirements, including 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 the EU directives 93/42/EEC and 98/79/EC on medical devices and in vitro diagnostics (IVDs) respectively.

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

In practical terms, the UK MDR 2002 provide for the manufacturer to successfully perform the required pre-market conformity assessment and to establish sufficient procedures to fulfil the manufacturer’s 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 and penalties for offences include 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 EU in vitro Diagnostic Medical Devices Regulation (EU IVDR) apply in EU member states from 26 May 2021 and 26 May 2022 respectively.

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

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 provides the Secretary of State (SoS) with powers to amend the existing regulatory framework regarding human and veterinary medicines, and medical devices in the UK. The MMD Act 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.

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, or 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.

Pharmaceuticals

The Human Medicines Regulations 2012 (SI 2012 /1916) apply to medicinal products for human use and provide a regime for the authorisation of these products; for the manufacture, import, distribution, sale and supply of those products; labelling and advertising; and for pharmacovigilance.

Blood products

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

Personal protective equipment (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. Clearly the popularity and widespread use of this product has skyrocketed during the COVID-19 pandemic.

  • Surgical (medical) face and transparent face masks – face masks 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 intended to protect the wearer – masks which are intended to protect the wearer are considered as PPE 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 – face coverings for 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 referred to above.

In recent years, there has been a trend towards an increased number of consumer products which are not medical in nature, but which 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 the tendency for such products 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 (hereafter 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 Northern Ireland Protocol to the UK/EU Withdrawal Agreement.

The UK Cosmetics Regulation is enforced in the UK via the UK Cosmetic Products Enforcement Regulations 2013 which specifies 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. These include:

  • the Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR);
  • the GB Classification, Labeling, 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 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:

  • 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; and
  • 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 reflected the Protocol on Ireland/Northern Ireland.

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 form of either revised laws and/or increased guidance on the application of legislation as it currently stands, in the near future. However, currently, these newer technologies are 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 are the applicable product safety regulations as set out at 1.1 Medical Devices.

Cannabis-Based Products for Medicinal Use (CBMPs)

The legalisation of CMBPs 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 Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance to specifically address CBD products, setting out the MHRA’s position on the classification of CBD products and the supply of CBPMs. In November 2020, the Advisory Council on the Misuse of Drugs (ACMD) recommended that the ACMD should be commissioned to assess the impact of the rescheduling CBMPs over two years as there is not yet sufficient evidence available to fully assess any and all consequences of the 2018 legislative change. They also recommended the UK government review international legislation facilitating the use of CBMPs.

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 is often required to determine the applicability of a product safety regime to a product. 

Some examples of common borderline product categories are below.

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 or 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 it is claimed 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 for 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.

Personal Protective Equipment and Medical Devices

As noted above, in 1. 1 Medical Devices, whether an item is a medical device or 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 a product’s 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.

There are certain requirements in relation to the manufacturing and design of medical devices and consumer health products 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 below.

Medical Devices and Related Products

Quality management systems

BS EN ISO 13485:2016, a stand-alone quality management standard (QMS), derived from the internationally recognised and accepted ISO 9000 quality management standard series, is a harmonised standard under the UK regulations. This standard sets out quality management system requirements in medical device design and manufacturing, which, includes 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 set 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 general requirements for manufacturers of cosmetic end products according to the equipment, production facilities, inputs, control of hygiene, production, as well as hygiene requirements for personnel, laboratory control, labelling, monitoring of complaints and product recalls.

The GMP ISO 22716 are 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.

There are several obligations which relate to corporate social responsibility, the environment and sustainability applicable throughout the product life cycle, contained within product safety legislation but also in discrete pieces of legislation. Some examples include the following.

  • Sourcing – through several pieces of consumer electronics and general chemicals legislation, which have 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; this statement will detail 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 targeting consumer electronics, but which have 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.
  • Waste disposal – there are requirements, again largely targeting consumer electronics, that have application to medical devices and consumer health products, but also fit-for-purpose legislation, that requires decontamination before 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.
  • 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.

The making of product claims has been a focus of regulators for some time, on the basis the messaging given to consumers does substantially impact their purchase decisions and therefore has the potential to mislead. Product claims are often the basis for determination of what product safety regime applies, as discussed in 1.4 Borderline Products, and is important on that basis also.

The nature of these regulations pertain, 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 health care 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.

Medicines

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

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

  • 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 ASA to provide full details together with information about those who supervise and administer them; practitioners must have relevant and recognised qualifications.
  • 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.
  • 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.
  • Must hold proof before claiming or implying that a minor addiction or a bad habit can be treated without effort from those suffering.
  • Must not encourage consumers to use a product to excess and must hold proof before suggesting their product or therapy is guaranteed to work, absolutely safe or without side effects.
  • 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.

Pre-marketing obligations are mainstay requirements under UK product safety laws. These obligations can be multi-faceted 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); obtaining pre-approval or at least notifying regulatory authorities about the existence of a new compliant product on the market; and placing 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 nature 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, conformity assessment bodies. 

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

  • benefits must outweigh risks and achieve the claimed performance – this must be proven with supporting clinical evidence and investigation;
  • chemical, physical and biological properties for medical devices;
  • 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. 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 to place a device on the UK market. Products will therefore have to comply with UKCA marking requirements from that point onwards, though 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 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 Great British 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 in entering the EU, in many ways the distinction between the two markets may present an opportunity. The UK has already taken advantage of its position moving away from the EU legislative regime, in an 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 applicable safety regimes:

  • consultation organised by the Office for Product Safety and Standards in June 2021 to modernise product safety laws;
  • the potential review and reform of the Consumer Protection Act of 1987; and
  • UK DEFRA’s review of genetically modified organisms (GMOs) legislation in terms of narrowing the definition of products that fall under GMO-specific regimes in the UK

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, which continue to attach for a substantial portion or the entire life of a product in circulation within the UK market, are aimed at ensuring that products remain compliant and safe anytime they are available to end users. The system imposes prescriptive requirements on entities within the supply chain for monitoring the same, and liaising with authorities to confirm the same. It also requires action to be taken where a product fails to adhere to the mandatory requirements, or otherwise presents safety risks; both in terms of reports to authorities but 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 (FSCA) 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, and describes 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.

In addition to the above, field safety corrective actions (FSCAs) must also be reported if necessary. FSCAs are actions affecting devices already distributed and 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, which 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 Office for Product Safety and Standards (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. The Secretary of State 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

For food supplements, 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 have oversight of 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 of 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.

An overview of the regulatory authorities relevant to oversight of medical devices and consumer health products is 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 and is 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.
  • There are also several authorities responsible for overseeing the compliance by manufacturers 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, then they fall within the remit of the MHRA.

If not:

  • cosmetics are supervised by the BEIS, the OPSS and UK Trading Standards for enforcement and market surveillance; and
  • food supplements are covered by the Food Standards Agency (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 and therefore the MHRA is in charge of ensuring compliance by manufacturers of those products.

CBD Products

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

Borderline Products

One of the MHRA’s powers is to determine whether a product is a medical device or medicine. If it is, then 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 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:

  • 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 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 their 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 which 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 them;
    2. monitor the UK-approved bodies designated by the MHRA to assess the compliance of manufacturers 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 which 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 which 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 to 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.
  • 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.

Food Standards Agency

The Agency has multiple enforcement powers to:

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

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

The General Product Safety Regulations 2005 (GPSR) provide the requirements for all consumer products that are not governed by more specific regimes. Under the GPSR, it is anenforceable offence for a producer or distributor, to sell or to place on the market a product which is not safe or which they know or should have presumed to be an unsafe product based upon the information in its possession. The penalty for such offences under the GPSR is up to 12 months imprisonment and/or a fine.

To fail to report to authorities under Section 20(3) of the GPSR is also an offence and 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 Medical Devices Regulations 2002 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 be typically 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.

Often claimants 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 which 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 breach of either express terms, or those implied by the Consumer Rights Act 2015 (CRA) in respect of (i) the fitness for purpose of the product, (ii) it being as described, and (iii) it being of satisfactory quality.

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

  • 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.
  • The breach of contract has led to loss.

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. Post-Brexit the situation is as set out below.

CPA

Generally, UK courts, as with other European-based 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 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 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.

  • Standard basis, under CPR 44.3(2) – 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 who has an indemnity costs order made in their favour is more likely to recover a sum which 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.

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

The court has a 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 Civil Procedure Rules. Once made, it can only be withdrawn within the “relevant period” (of at least 21 days) with leave of the court. Thus, if a crucial piece of evidence is received during the “relevant period” which 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 it 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 which 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. Such an offer may still be relevant to costs, as it is an attempt to settle the claim, but does not 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 which may arise out of a death and a Coroner is expressly prohibited from making findings which determine questions of civil or criminal liability. However, the evidence which 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, which may arise from the circumstances of 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 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.

Informal Mechanisms

The courts can manage mass tort litigation informally, including by hearing one or more representative test cases at trial while staying remaining cases. The test case decision is not binding on parties to the other claims; however, the decision is intended to determine common issues relevant to the subsequent cases to assist parties to resolve remaining claims without further litigation.

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

Formal Mechanisms

Group litigation orders

A group litigation order (GLO), under CPR 19 Section III, allows the management of multiple claims which 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 they 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

Representative actions, under CPR 19 Section II, can be brought by one or more claimants (the qualified representative entity) on behalf of a group considered to have the “same interest”. The appeal decision in Lloyd v Google LLC [2019] EWCA Civ 159 determined that the “same interest” meant, in practice, those who were victims of the same alleged wrong and had sustained the same damage where the defendant was unable to raise a defence specifically responding to a claim by one represented claimant that did not equally apply to all others in the group. Accordingly, a group would not be considered to have the “same interest” if defences were applicable in some individual claimant claims but not to others. The matter has been appealed to the Supreme Court and was heard in April 2021. The Supreme Court’s decision is eagerly anticipated. These actions operate on an "opt-out" basis, such that all group members will be automatically included in the group and represented in the action, and a judgment will be binding on all those represented unless they expressly state they wish to be excluded. Such actions are rare, although there are signs they may become more widely used.

Alternative dispute resolution (ADR) offers a bespoke way of resolving disputes which are not available through the litigation or arbitration process. ADR often includes 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 is currently undertaking a consultation on waste prevention proposals for products, the “Waste Prevention Programme for England”. 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 currently focuses on construction products, textiles, furniture, electronics, vehicles, food and plastic packaging. However, we anticipate that such measures will eventually impact the products in the future.

There is wide-ranging imminent legislative reform currently in progress in respect of 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 that 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" focusses 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 result of the review, and any hard or soft laws created on the basis of the same, would mark a significant development in UK product safety laws, which are over 30 years old.

The review is in parallel to a similar review being held at EU level, 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 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.

Given the implementation of local UK laws to enact EU-level obligations prior to Brexit and/or the direct effect of EU laws in the UK at the time of initial pre-Brexit implementation, much of the legislative framework for product safety in the UK remains substantively unchanged post-Brexit. However, various pieces of UK legislation, such as, most relevantly, The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, were enacted to amend EU-based legislation to make correct references to the UK rather than the EU, and to ensure the continued applicability of the legislation in the UK. Supplementary legislation was also required to be enacted in some sectors to empower relevant UK law-makers to implement future changes to UK legislation. In some specific areas, including medical devices, because of imminent legislative changes in the EU that did not take effect prior to Brexit, the EU and UK positions already deviate significantly. Future deviation is also likely, particularly in the context of legislative reviews and amendments of UK and EU product safety systems currently underway.

The Brexit Agreement ratifies the reforms, which were anticipated by stakeholders in the life sciences industry and provides an opportunity for change and growth. Despite the new trade conditions and regulatory processes, the aims of these alternative processes seek to ensure there is minimum disruption to established good practice in innovation, manufacturing and distribution.

The flexibility, which may be gained by the UK as a result of any divergence of law/regulation that may now result is likely to stimulate innovation, although significant investment still needs to be maintained.

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 personal protective wear. 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 the following.

  • A heightened risk of cybersecurity cases involving potential software data breaches such as COVID Test and Trace.
  • An increased use of emerging technologies such as genomics, telehealth and AI in the drug discovery process.
  • A greater reliance upon data-driven technologies and related products, which may lead to a potentially more complex product liability matrix where liability may fall on multiple defendants.
  • An increase in home-grown products and technologies by UK-based producers, which may give rise to liability exposure in unanticipated circumstances and may result in more actions being brought domestically.
  • An emerging trend towards more online marketplaces, and consumer purchases of non-compliant products or products not intended for their markets.
  • A proliferation of guidance, exemptions and derogations provided by regulators, in particular life sciences regulators, including:
    1. the granting of exemptions, derogations and expedited pathways, including in respect of testing kits, medical devices, remote audits, COVID-19 vaccines, compassionate use medicines, labelling and packaging flexibilities for vaccines and supply and distribution methods for vaccines; and
    2. the grant by governments of future-looking indemnities or protection from suits in respect of COVID-19 products, or otherwise consideration of compensation schemes for victims of COVID-19 products.

Further detail is provided in the UK Trends and Developments chapter in this guide.

Kennedys

25 Fenchurch Avenue
London
EC3M 5AD
UK

+44 20 7667 9677

+44 20 7667 9777

Sarah-Jane.Dobson@kennedyslaw.com www.kennedyslaw.com
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Trends and Developments


Authors



Kennedys is a global law firm with particular expertise in litigation and dispute resolution, especially in defending insurance and liability claims. It has 66 offices, associations and co-operations across the UK and Europe, the Americas, Asia Pacific and the Middle East. The firm has a market-leading team handling product safety and regulation, large-scale product liability, recall and "mass tort" litigation and international claims. The core team is comprised of nine partners in London supported by more than 40 associates, as well as many of partners and colleagues across Kennedys' international offices. A number of the firm's lawyers have requalified in the law following careers in relevant industries (such as engineering, construction and medicine), which broadens its expertise for clients’ benefit. Kennedys acts for parties across various industries and has gained in-depth expertise in high-profile and complex matters involving a wide range of products, including automotive, chemicals, pharmaceuticals, medical devices, healthcare products and consumer goods.

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 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 amongst 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 the aforementioned 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 also been notable advancements in 3D printing for use in the production of patient-specific models and some orthopaedic implants. 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 (ADRs) 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 a report produced by the UK’s independent Regulatory Horizons Council about the regulation of medical devices in the UK, new technology has also been underlined as significant area of development for UK medical devices industry.

Contemporary Food Manufacturing Practices

There has been significant policy initiatives around the development of new food products and manufacturing processes across the UK. This policy agenda is largely reflective of:

  • the change in consumer behaviour that now tends to favour ethically and sustainable sourced foods;
  • recognition, following the COVID-19 pandemic, that there may be some inefficiencies within internationalised or complex food supply chains or food manufacturing practices; and
  • the modern consumer’s long-running quest for wellness, health and new and innovative food products.

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 irrespective 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 by 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 allowed the UK the opportunity to consult separately on the implications of technological advances for food and supplements.

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, the use of cannabis and CBD 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 April 2021, according to the FSA there are only approximately 40 products validly holding an authorisation in the UK under the mandated scheme. The FSA has emphasised its enforcement policy will focus on those who have not shown “interest in moving towards compliance”. There are other applications that the FSA have 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 need largely 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 alive to 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, the following being some examples of the broad and varied nature of the actions.

  • The MHRA published specifications and detailed guidance on certain topics, explaining existing regulatory pathways, including for a rapidly manufactured ventilator system (RMVS) to enable the fast tracking of the production of "minimally clinically acceptable" ventilators.
  • Regulations were relaxed in limited circumstances, and limited derogations granted, for example, in relation to CE marking of personal protective equipment (PPE) and ventilators placed on the market, expediting manufacturing practices for COVID-19 products and preventing shortage of critical medical devices. This was not a standalone event as the MHRA issued regular guidance on the flexibility of the approval process, including but not limited to expediting the review of clinical trials, the introduction of adaptive clinical trials allowing for planned modifications of aspects of the trial in response to the changing landscape of the pandemic and relaxing reporting regimes.
  • Broader, far-reaching changes that were not directly related to the pandemic, but which allow increased focus of industries on the fight against COVID-19, were also implemented. This includes the aforementioned grace periods extended to medical devices entering the UK market and requiring registration with the MHRA.

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, however 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 which outline its ongoing regulatory strategy, which aim to incorporate some of the learnings from the COVID-19 pandemic.

Counterfeit Products

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 resultant change of lifestyle of consumers. Some examples of products that were produced by counterfeiters and targeted by regulators during the pandemic include those comprising:

  • preventative measures – non-genuine, non-compliant or falsely compliance-marked hand sanitisers;
  • detection measures – COVID-19 detection tests that were ineffective, non-compliant or those which made false claims as to nature of the product, including UV light sanitiser devices claiming to be COVID-19 tests; and
  • treatment measures – herbal remedies (including teas and essential oils) and vitamins that claimed to cure COVID-19.

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 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 continues to focus on corporate social responsibility, sustainability and environmental 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, in particular, "vegan", "organic", natural", "not tested on animals", and "recyclable", amongst others.

Most recently, the UK Competition and Markets Authority (CMA) has 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, that found that 40% of green claims made online could be misleading.

The ASA has also recently 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 recyclability of products must take account of the full life cycle of the product.

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 timing of the same, 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:

  • Directive 90/385/EEC on active implantable medical devices (EU AIMDD);
  • Directive 93/42/EEC on medical devices (EU MDD); and
  • Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).

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, including in vitro diagnostic medical devices (IVDs), placed on the British market need to be registered with the MHRA with a grace period for registering the following:

  • Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products, which must be registered from 1 May 2021;
  • other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs, which must be registered from 1 September 2021; and
  • Class I devices, custom-made devices and general IVDs (that do not currently need to be registered), which must be registered from 1 January 2022.

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 will become so in May 2022.

The UK has foreshadowed several times the development of a new regime for itself, already 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.

  • The Independent Medicines and Medical Devices Safety (IMMDS) Review delivered a report in July 2020 highlighting the importance of strengthened regulations in relation to medical devices.
  • In July 2021, the government issued a response the IMMDS Review detailing the government’s response to the report’s nine strategic recommendations and 50 "actions for improvement". One of the recommendations in the IMMDS report was that the MHRA "needs substantial revision particularly in relation to adverse event reporting and medical device regulation… to ensure that it engages more with patients and their outcomes".
  • The government has accepted this recommendation and highlighted that the MHRA has initiated a programme of work in line with its’ Delivery Plan for 2021–23 "to improve how it listens and responds to patients and the public, to develop a more responsive system for reporting adverse incidents, and to strengthen the evidence to support timely and robust decisions that protect patient safety".
  • In addition, the response highlighted the introduction of the MHRA Safety Connect programme as a new and responsive vigilance service to detect and respond to safety concerns with any medicine, medical device or blood product more quickly and more comprehensively than ever before. 
  • More recently, the Regulatory Horizons Council made its report on medical devices regulation with some key recommendations to be addressed in any new regulatory regime:
    1. the regulation of medical devices should be centred on the needs of patients, informed by patients, record outcomes that matter to patients, and provide evaluations that are understandable to patient;
    2. there is a need to increase capacity to address present needs and emerging opportunities;
    3. there is an opportunity for the UK in international leadership and partnership in medical devices;
    4. there is an opportunity to use medical devices as a template to help enable regulatory innovation that improve patient safety, system efficiency and UK growth; and
    5. there is a need to build resilience and prepare for future threats.

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 are challenges that are expressly acknowledge and addressed in the MHRA’s future strategy plan, however. It is also evident that the UK regulator will seek international collaboration further afield post-Brexit.

Kennedys

25 Fenchurch Avenue
London
EC3M 5AD
UK

+44 20 7667 9677

+44 20 7667 9777

Sarah-Jane.Dobson@kennedyslaw.com www.kennedyslaw.com
Author Business Card

Law and Practice

Authors



Kennedys is a global law firm with particular expertise in litigation and dispute resolution, especially in defending insurance and liability claims. It has 66 offices, associations and co-operations across the UK and Europe, the Americas, Asia Pacific and the Middle East. The firm has a market-leading team handling product safety and regulation, large-scale product liability, recall and "mass tort" litigation and international claims. The core team is comprised of nine partners in London supported by more than 40 associates, as well as many of partners and colleagues across Kennedys' international offices. A number of the firm's lawyers have requalified in the law following careers in relevant industries (such as engineering, construction and medicine), which broadens its expertise for clients’ benefit. Kennedys acts for parties across various industries and has gained in-depth expertise in high-profile and complex matters involving a wide range of products, including automotive, chemicals, pharmaceuticals, medical devices, healthcare products and consumer goods.

Trends and Development

Authors



Kennedys is a global law firm with particular expertise in litigation and dispute resolution, especially in defending insurance and liability claims. It has 66 offices, associations and co-operations across the UK and Europe, the Americas, Asia Pacific and the Middle East. The firm has a market-leading team handling product safety and regulation, large-scale product liability, recall and "mass tort" litigation and international claims. The core team is comprised of nine partners in London supported by more than 40 associates, as well as many of partners and colleagues across Kennedys' international offices. A number of the firm's lawyers have requalified in the law following careers in relevant industries (such as engineering, construction and medicine), which broadens its expertise for clients’ benefit. Kennedys acts for parties across various industries and has gained in-depth expertise in high-profile and complex matters involving a wide range of products, including automotive, chemicals, pharmaceuticals, medical devices, healthcare products and consumer goods.

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