Healthcare: Medical Devices 2023 Comparisons

General Overview

The EU product safety regime is a sophisticated, multi-faceted regime which seeks to balance the rights of consumers, patients, and users of products, with the rights of businesses. Its aim overall, therefore, is to provide the highest level of public and patient safety, while not stifling innovation.

As the safety regime pertains to medical devices and consumer health product categories, it has the following key legislative pillars.

Separate product safety regimes

Medical devices and health products are recognised to have unique risks and, given their comprehensive nature, their safety regimes operate independently from any other product safety legislation. 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 general product safety regimes, to take effect where specific risks are introduced by recognised product categories. Relevant to medical devices and health products are sector-specific laws in the following categories:

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

General product safety regime

This mandates overarching requirements for the safety of consumer products in the EU, and tends to operate where the aforementioned regimes, or no more specific requirement, have effect.

Member states are involved in drafting the above-mentioned applicable regimes to a varying degree, dependent on the nature of the EU laws applicable – with regulations being directly applicable and member states needing to implement directives into local laws to make them legally binding. Evidently, although the EU system always strives for maximum harmonisation across the laws of all EU member states for which an EU law is the basis, local implementation of laws tends to increase the likelihood for local deviations and variance.

Overall, the principle of “mutual recognition” is at the core of the EU product safety regimes outlined above, in so much as a product that is compliant with a local product safety regime in one member state is considered to be compliant and saleable in any other EU market. This guiding principle allows for the free movement of goods in a single market, and both concepts are fundamental principles of the EU product safety system.

Generally, the above-mentioned regimes have the following core features:

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

Specific Regimes

Medical devices

The EU medical devices legislative suite has been subject to significant overhaul, based on perceived shortcomings of the system (including the lack of oversight of notified bodies and the inability to recover compensation in circumstances where manufacturers went bankrupt) that were brought to light by a series of high-profile litigation cases.

The former mainstay pieces of EU medical devices legislation have now been phased out:

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

The above regime has been replaced by the following pieces of legislation:

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC; Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; and repealing Council Directives 90/385/EEC and 93/42/EEC (EU MDR); and
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (EU IVDR).

The laws regarding medical devices belatedly came into force in May 2021 following a short delay of one year (the COVID-19 pandemic was cited as the primary reason for this delay). The laws regarding in vitro medical devices came into full effect in May 2022 and are subject to a progressive roll-out, following concerns raised by the life sciences and healthcare industries that the implementation of the new regulation would be extremely challenging in light of a shortage of notified bodies and the deployment of resources due to the COVID-19 pandemic. The progressive roll-out allows the continuous supply of essential in vitro devices.

Against a growing risk of potential medical device shortages in the EU, on 6 January 2023, the European Commission (EC) published draft legislative proposals to amend the transitional provisions for the EU MDR and EU IVDR with a view to giving manufacturers more time to bring their devices into conformity with the regulations. The proposal was approved by the EU Council and European Parliament on 7 March 2023 and was published in the Official Journal of the EU on 20 March 2023, with immediate effect.

Personal protective equipment (PPE)

Generally, medical PPE can fall under separate pieces of legislation, depending on the applied use of the product itself.

• PPE intended to protect patients during surgical procedures or in other medical settings is classed under medical devices and the above-mentioned medical devices regime applies.
• Products intended to protect the user, including in respect of medical or health risks, are regulated under the PPE Directive (2016/425).

Medical instruments

Medical instruments are considered medical devices and the above-mentioned medical devices regime applies.

There are a range of consumer products which are not medical in nature, but which may be related to health and well-being. In recent years, these product categories have increased, perhaps in line with the increased focus on consumer health due to the COVID-19 pandemic, or otherwise as part of the growing trend towards health and well-being.

Cosmetics

Cosmetics in the EU are regulated under the Cosmetics Regulation (Regulation (EC) No 1223/2009), which often works in conjunction with other chemical regimes, including relevantly, the EU Regulation on Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) and the EU Regulation on classification, labelling, and packaging (CLP) of chemical substances and mixtures. There are currently proposals for the targeted revision of these regimes as part of the European Commission’s Chemical Strategy for Sustainability and the wider European Green Deal, which seeks to protect citizens and the environment against hazardous chemicals and encourage innovation to foster the development of safer and more sustainable alternatives.

The European Commission has published draft legislation which seeks to amend the EU Cosmetics Regulation 2009 by making changes to the use of certain chemicals as well as adding to the list of prohibited substances. The amended regulation is expected to enter into force by the end of 2023.

Biocides

Regulation (EU) 528/2012 regulates biocidal products in the EU and mandates the following steps: (i) approving active substances in biocidal products; and (ii) authorising the supply and use of biocidal products and articles treated with biocidal products. While the regime ostensibly sets up an EU-wide regulatory framework, because the approval of active substances still requires the application of national-level laws and/or processes, in practice, the regulation can be difficult to navigate in terms of the pan-European marketing of goods.

Food and Nutritional Supplements

Several different legislative regimes may potentially apply to health food and nutritional supplements (“nutraceuticals” as they are sometimes called). There is no comprehensive system to cover these product categories, however. In the case of some particular supplements or ingredients, including, for example, cannabis or CBD, ingestible products containing these substances may be considered “novel foods” and come under the Novel Food Regulation 2015/2283, which replaced Regulation (EC) No 258/97 (Council and Commission Regulation (EC) No 1852/2001). Otherwise, nutritional supplements generally, including nutraceuticals which are expressly defined, can be included within the Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of member states relating to food supplements. Health food products are likely to fall within the scope of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (General Food Safety Law). More specific regimes may apply where supplements or food additives have a particular dietary purpose or target group, for example, formulas for infants.

Pharmaceuticals

The safety of pharmaceutical products in the EU is primarily governed by two key pieces of legislation:

• Directive 2001/83/EC on the community code relating to medicinal products for human use; and
• Regulation (EC) No 726/2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use, and establishing a European Medicines Agency.

Separate legislation applies in respect of specific medicinal products, including so-called “orphan” medicines for the treatment of rare diseases (Regulation (EC) No 141/2000), medicinal products for children (Regulation (EC) No 1901/2006), and advanced therapy medicinal products (Regulation (EC) No 1394/2007). The product safety assessment processes required to market these products in the EU and conduct clinical trials is governed by the Clinical Trials Regulation (536/2014), which became applicable on 31 January 2022 and replaced the Clinical Trial Directive (2001/20/EC).

Blood products

The safety of blood products is generally provided for under Directive 2002/98/EC on the safety and quality of human blood and blood components, and Directive 2004/23/EC on the safety and quality of human tissues and cells. However, this legislative suite was recently the subject of a review and is likely to be amended shortly.

Psychedelics

As it stands, psychedelic substances are classified as “Schedule 1” substances in Schedule 1 of the UN’s Convention on Psychotropic Substances of 1971. There is currently no EU-wide regulation of psychedelic substances. However, as research and clinical trials continue to produce promising results, and against a backdrop of a worsening mental health crisis across the EU, there are growing calls by EU parliamentarians to introduce regulation to facilitate the safe use of psychedelics.

CBD for medicinal purposes

Medical CBD-containing products can attract the application of a range of legislation, including in some instances the Cosmetics Regulation and the food safety regime (both outlined in 1.2 Healthcare Products), and the medicines regime (outlined in 1.1 Medical Devices).

In recent years, there has been discussion of different regulatory frameworks in relation to CBD for medicinal purposes, as set out in a report published in 2018 by the European Monitoring Centre for Drugs and Drug Addiction. There have also been legislative developments at national level in recent years, with a small number of member states introducing laws to regulate the use of CBD, including Germany and Greece.

Regulation of clinical trials

The EU’s Clinical Trials Regulation, which entered into force on 31 January 2022, repealed the Clinical Trials Directive (EC) No 2001/20/EC. It aims to harmonise the processes for assessment and supervision of clinical trials throughout the EU, increase transparency and access to information for parties interested in clinical trials conducted throughout the EEA, and improve efficiency. For example, clinical trial sponsors are also able to submit a single online application via a single online platform known as the Clinical Trials Information System, seeking approval to run a clinical trial in several EU member states.

The apparent inability of many product safety regimes to deal with newer technologies is a consistent criticism that is raised in the context of reviews of existing legislative frameworks. 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 the legislation as it currently stands. However, for now, these newer technologies are contemplated in the existing regulatory frameworks.

Consequently, medical apps, telemedicine software, and wearables with a medical purpose generally fall under the medical devices regime described in 1.1 Medical Devices. However, the applicability of any regime to these product categories needs to be carefully determined, and with the requisite expertise, given the much stricter requirements imposed by the medical devices regime as compared to general consumer product regimes.

Stem Cells

In the EU, stem cells are deemed to be “advanced therapy medicinal products”, namely medicines for human use based on genes, tissues, or cells, when they undergo extensive manipulation or are used for a different essential function. The relevant legal framework is provided by Regulation (EC) No 1394/2007.

Applicable regulatory regimes, as discussed throughout 1. Applicable Product Safety Regulatory Regimes, determine what regulatory obligations those within the supply chain must adhere to (see 2. Commercialisation and Product Life Cycle) and the determination of which regime applies to which product is therefore of fundamental importance. In many instances, several regimes can apply; however, in other instances, the applicable legislation may expressly exclude the operation of certain other legislative regimes.

Given the number of possibly applicable legislative regimes, and the potential for overlap (and/or exclusion) between them, the determination of applicable regulatory regimes often requires expert input and varies significantly from case to case, based largely on the specific use of the product and its marketing claims.

In recognition of the importance, and also difficulty, of determining the classification of a product in terms of what regime applies, and in particular, the above-mentioned borderline products, the regulatory authorities have released guidance on the topic. The COVID-19 pandemic meant that certain product categories, as well as the nuances of classification between the potentially applicable regimes, were particularly highlighted. More specific guidance was therefore produced in the context of the pandemic, which gave some clarity in what, ultimately, remains a grey area.

Common Borderline Products

For common product categories that tend to overlap, and therefore where there are likely to be borderline products (ie, products that straddle more than one regulatory regime), the relevant main points of guidance are as follows.

Medicines and medical devices

Sometimes medicines are used in combination with a medical device, usually to enable the delivery of the medicine – these are known as “combination products”. If the principal intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under the pharmaceutical regime. The medical devices regime introduced new requirements for the involvement of notified bodies and/or the seeking of a regulator’s input, where a medicine contains a medical device (integral part). On 26 April 2022, the European Commission (EC) published guidance on the borderline between medical devices and medicinal products under the EU MDR, which was endorsed by the Medical Device Co-ordination Group, composed of representatives from all EU member states and chaired by a representative of the EC.

Personal protective equipment and medical devices

As noted in 1.1 Medical Devices, medical PPE can be considered personal protective equipment or a medical device based on its use. Where the product is worn to protect patients, this is generally considered a medical device. Where the product is worn to protect the user, it is usually considered to be personal protective equipment.

Cosmetics, biocides, and medicines

Generally, these product categories can be distinguished on the basis of any product claims made. Broadly, any claims that appear to be cosmetic in nature (ie, perfuming, moisturising, or otherwise beautifying) mean a product is more likely to be a cosmetic product. Conversely, where there are medical claims, these products are likely to be governed by the pharmaceuticals regime. If there are antibacterial/antiseptic claims, these are likely to result in the product being considered a biocide, in which case the biocides regulatory regime applies.

Certain requirements in relation to the manufacture and design of medical devices and consumer health products are contained within the applicable EU laws 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 in the EU.

Relevant requirements for design and manufacturing practices include that:

• medical devices need to comply with a prescriptive set of requirements in relation to good manufacturing practices (GMPs) and good distribution practices (GDPs), as contained within the applicable legislative regime; and
• pharmaceuticals and cosmetics are also subject to GMP requirements within their legislative regime.

The nature of these requirements is product specific, but is often contained in relevant technical standards and typically covers risk of contamination, storage, and hygiene practices at a minimum.

Corporate social responsibility, environmental, and sustainability considerations are built in to many product safety regulatory regimes applicable to medical devices and consumer healthcare products, as well as general consumer products, including most relevantly the following laws:

• the Conflict Minerals Regulation, as it applies to products containing certain metals;
• the Ecodesign Directive, as it applies to products capable of deploying energy-saving practices;
• the Energy Labelling Regulation 2017/1369, as it applies to energy-related products;
• the Directive 2012/19/EU on Waste Electrical and Electrical Equipment (WEEE), as it applies to electronic equipment;
• the Directive 2011/65/EU on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS2);
• the Directive 2006/66/EC on Batteries and Accumulators and Waste Batteries and Accumulators (the Batteries Directive);
• the Directive 94/62/EC on Packaging and Packaging Waste; and
• the Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).

On 30 November 2022, the EC proposed to revise the current Directive on Packaging and Packaging Waste with a view to:

• preventing the generation of packaging waste;
• ensuring that all packaging on the EU market will be recyclable in an economically viable way by 2030; and
• increasing the use of recycled plastics in packaging.

Some of the aforementioned laws also encompass the “Right to Repair”, as established by the EU parliament in November 2020, with a view to saving costs for consumers and facilitating the development of a circular economy. On 22 March 2023, the EC proposed a draft Directive setting out common rules promoting the repair of goods.

The EC’s proposal for a Directive 2022/0051 on Corporate Sustainability Due Diligence (the CSDD), first published on 23 February 2022, seeks to place greater corporate responsibility on large EU and non-EU companies to identify, prevent, mitigate, and bring to an end adverse impacts of their activities on human rights and on the environment that may occur within their own operations and that of their supplies. Non-compliance will attract significant financial penalties as well as a risk of civil liability.

The use of advertising claims is particularly stringently regulated in the medical devices and consumer health product categories, to a much greater extent and with greater specificity than for general consumer products or other product categories in the EU. The basis for such strict regulation is multifaceted in nature:

• often, determination of which regulatory regime applies to a product is dependent on any product claims made;
• the nature of the products is usually such that they may present the greatest safety risk (often being used in ways that are linked to health and/or in the context of disease or the treatment of disease); and
• given the important health consequences that may flow, it is particularly important that consumers and/or users are not misled in relation to these product categories.

The nature of these regulations pertain, generally, to the characteristics of the product, including any environmental claims. Some examples of particularly pronounced marketing and advertising requirements are within the cosmetics product safety regimes. The applicable regime for marketing and advertising of cosmetics has the following basis:

• an express requirement within the mainstay product safety cosmetics regulation specifying requirements for a claim;
• technical guidance in respect of the above, issued by the EC, which provides specific guidance and criteria on making claims; and
• application of rules relating generally to advertising, marketing, and unfair claims made to consumers.

On 22 March 2023, the EC published a proposal for a Green Claims Directive in an attempt to tackle the growing practice of greenwashing, namely the practice of making misleading or unsubstantiated environmental claims.

Pre-marketing requirements, marketing authorisations, and post-marketing obligations are key features of all product safety regimes in the EU, including as to how they apply to medical devices and consumer health products.

Pre-Marketing Requirements, Including Safety and Conformity Assessments and Testing

All product safety regimes in the EU, including those relating to all classes of product outlined in 1.1 Medical Devices, require pre-marketing steps to be taken to ensure the safety and conformity of products. Many regimes impose specific, unique requirements that are seen to address particular risks associated with specific products, as follows.

Medical devices

Generally, all medical devices must undergo a conformity assessment to ensure they are safe and comply with applicable legislation (or technical standards in practice). The rigour and need for involvement of a neutral third party (notified body) to assist with this process, is contingent upon the risk profile of the product. The greater the risk the product poses, the more likely the product is to require the involvement of a notified body. A technical file documenting compliance of the product with requirements is also necessitated by regulations.

Pharmaceuticals

Clinical trials are required before marketing medicinal products in the EU, to determine the safety and efficacy of these products.

Cosmetics

Safety assessments, known as Cosmetic Product Safety Reports (CPSR) must be carried out by appropriately qualified individuals under the cosmetics regime. The assessment generally contemplates all aspects of the product, from ingredients to risk exposure, stability, disposal, and sustainability of the product. Generally, information about pre-market testing and compliance activities undertaken, and the outcomes of the same, establishing that the product is safe and complies with mandatory regulatory requirements, must be recorded (Product Information File – PIF) for a period of ten years by the person/entity responsible for regulatory compliance for the cosmetic product (Responsible Person).

Biocides

Generally, approval of individual substances and then of whole products is required. There are currently pre-approved substances, at a member state level, which may mean, in some member states and under some circumstances, that this requirement for use of the substance to be approved is bypassed and only the approval for use of the product is required. There have been some issues with the transition of the older regime to this newer iteration, and the migration of prior substance-level approvals under the older regime. This is complicated further by the application of national law in respect of certain, individual substances. On that basis, there may be some complexities for those seeking to have a substance approved, even if that substance has received prior approval in a different member state.

Marketing Authorisations

Not every product regulatory regime imposes a requirement for market or sale authorisation, and in fact this is seen to be a concept that is relatively uncommon and applies only in limited circumstances. Some examples of regimes that do impose this requirement are as follows.

Pharmaceuticals

The findings of any clinical trial form the basis of an application for marketing authorisation, which allows the manufacturer to market their products in the EU. These authorisations are based on the quality, safety and efficacy of the products. There are several potential routes available to those seeking to obtain marketing authorisations, including relevant centralised and decentralised procedures, as they apply to all EU member states or specific member states respectively. Market authorisations are entered into an EU-wide database maintained by the European Medicines Agency (EMA), known as the EudraGMDP.

Other regimes do not generally include a requirement for any sort of pre-market approval; however, a registration requirement is imposed on manufacturers and/or importers of new cosmetic products and medical devices in the EU, which is analogous to, though arguably less onerous than, an authorisation process.

Evidently the internationalisation efforts of companies are mostly driven by their commercial incentives and imperatives.

However, in terms of a legal framework perspective, the existence of customs/border checks of products is often the core driving force of internationalisation plans for companies.

The notion of “mutual recognition” throughout the EU allows the easy circulation of products within the EU region, and is often the basis on which companies decide to internationalise their products freely within that region.

Furthermore, the local language requirement, which is a well-established local law (rather than an EU-based law) requirement throughout the region under all product safety regimes, can often be the driving force for whether a company decides to expand into a country or not. The need for local language support for consumer complaints is another incentive in this regard.

On the other hand, the existence of borders between the EU and UK post-Brexit can act as a deterrent for a company’s expansion into one or both of these regions on the basis of duplication of requirements and enforcement of the same, notwithstanding the close geography.

Alongside pre-marketing requirements, post-marketing requirements are a fundamental aspect of product safety regimes applicable to medical devices and consumer health products in the EU. There are varying requirements and trigger points for post-market surveillance obligations and record-keeping practices across various product categories. Some examples of the more onerous requirements are set out below.

Corrective Action Obligations

Manufacturers, and in some instances other actors in the supply chain, have an obligation to address any product safety risks that become apparent in their products once these are circulating in the market, including by way of recall or withdrawal from the supply chain.

Post-market surveillance obligations for medical devices, for example, generally require the existence of:

• a comprehensive system to gather information on patient use of the product (post-marketing surveillance system);
• the appointment of a responsible person to ensure the continued compliance of products;
• the existence of a post-market surveillance system for collecting information and characterising the safety and performance of the device, or family of devices; and
• methods and processes to assess the collected information.

In accordance with the EU MDR, a European database on medical devices, known as EUDAMED, has been created to provide a live picture of the life cycle of medical devices made available in the EU. EUDAMED will integrate different electronic systems to collate and process information regarding medical devices and related companies, such as manufacturers, with a view to improving transparency through better access to information by the public and healthcare professionals as well as enhancing co-ordination between the different member states.

Notification to Regulatory Authorities

Depending on the nature of the product in question, this involves the following.

• Medical devices – medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU competent authorities.
• Pharmaceutical products – marketing and/or manufacturing authorisation holders are obliged to report to the EMA and any affected member states regarding any product quality defect, including a suspected defect, of a centrally authorised medicine which could result in a recall or abnormal restriction on supply.
• Cosmetic products – cosmetics regulations require notification to relevant member state competent authorities, without delay, of any serious undesirable effects (SUEs) attributable to the use of cosmetics.
• Products where the general consumer product safety regime applies in terms of reporting obligations – generally, there is a risk-based requirement to report to the authorities in the event that a product is not compliant with the applicable product safety regime.

National Regulators

There is no EU-level regulator that oversees product safety, including for medical devices and consumer health products. Generally, there are member state/national-level regulators for product safety – those that oversee and regulate general consumer products as well as product-specific regulators that oversee specific product categories, such as medical devices and consumer health products. Generally, the demarcation between these types of regulators is along the lines of the applicable regulatory regimes, as outlined in 1.1 Medical Devices. Across the EU, there is generally no hierarchy of regulators – regulators of specialist product categories have different scopes of work but regulators are not stratified in terms of oversight and there is generally only one level of regulators.

EU-Wide Regulatory Agencies

While there are no regulators at an EU-wide level per se, there are relevant EU-wide regulatory agencies for some relevant product categories, including medicines (the EMA) and chemicals (European Chemicals Agency or ECHA). These organisations do not typically get involved in actual enforcement practices, or authorisation processes, but they do provide expert guidance and broader policy input. The EC also regularly produces relevant guidance, including with expert groups who are specialists in specific product categories. For example, the Medical Devices Expert Group (MDG) of the EC produces comprehensive guidance in respect of the medical devices regime, in the form of the MEDDEV guidance documents.

Generally, for medical devices and medicines, the specialist regulators are also empowered to enforce specific regimes.

The issue of enforcement of product regulatory regimes was historically left to the member states, and was not governed at an EU level. This led to widely different regulatory enforcement practices across the EU – and often resulted in criticism that the enforcement of EU product safety laws was a weak link in an otherwise sophisticated regime.

Against this backdrop, there has been an increasing focus in recent years on better enforcement practices, and also better EU-wide enforcement practices for product safety generally, as part of the EU’s Goods Package. In particular, the Market Surveillance Regulation (2019/1020 – MSR), aims at enhancing as well as harmonising enforcement powers across the EU, as does Directive (EU) 2019/2161 on the better enforcement and modernisation of EU consumer protection rules, which came into force in January 2020.

Given the need for EU-level product safety laws to be implemented into national legislation by member states, member states are empowered to impose penalties for a breach of product safety regulations. Such penalties can vary considerably, and include monetary fines and – in rare instances – imprisonment of key individuals.

The EU mechanisms for product liability claims apply regardless of product classification, and can generally be divided into three main categories, as discussed below.

Statutory Liability Under Product Liability Laws

EU Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations, and administrative provisions of the member states concerning liability for defective products (the PLD) establishes strict liability offences for defective products. Key features of the legislation include:

• manufacturers, importers, and suppliers being jointly and severally liable;
• liability arising “for damage caused by a defect” in a product; and
• a “product” being defined broadly as “all movables” but expressly excluding “primary agricultural products and game”.

In bringing a claim, claimants are required to prove the following elements exist.

• Damage, including personal injury and/or property damage.
• A defect – a product is generally defective when “it does not provide the safety which a person is reasonably entitled to expect” as based on “all circumstances”, including the product’s presentation, its use, and the time it has been in circulation.
• A causal relationship between the damage and the defect, as based on the application of national member state laws on causation.

Those entitled to bring claims under the PLD are “injured persons”. There can be multiple claimants bringing a joint action, though not to the extent of amounting to a so-called class action in most instances.

Generally, claims under the PLD must be brought within three years from “the day on which the plaintiff became aware, or should reasonably have become aware of the damage, the defect, and the identity of the producer”. Member state laws may also apply to allow for a suspension of this time limit in some circumstances. The PLD also stipulates that the period for bringing claims is completely extinguished “10 years from the date on which the producer put into circulation the actual product which caused the damage, unless the injured person has in the meantime instituted proceedings against the producer”. This is known as the ten-year-long stop.

On 28 September 2022, the EC published proposals to reform the PLD, proposing a new Directive that would address the challenges and risks presented by new technologies and the circular economy. Amendments include:

• The alleviation of the burden of proof for claimants in product liability actions, particularly in relation to technical or scientifically complex products.
• The expansion of the definition of “product” to cover intangible items such as electricity, software, and digital manufacturing files. This will bring products such as connected/smart devices within the scope of the PLD.
• AI systems and AI-enabled goods are also proposed to fall within the PLD’s scope, meaning that compensation would be available when defective AI causes damage, without the injured consumer having to prove fault on the part of the manufacturer.
• Increasing the number of potential defendants who may be liable under the PLD. In addition to manufacturers of tangible hardware, providers of software and digital services would also be liable.

The proposal is making its way through the parliamentary process, with the EU council adopting its negotiating position on 14 June 2023. The new PLD, once finalised, will potentially come into force in 2024, followed by a 12-month period for transposition into national laws by member states.

Liability in the Tort of Negligence

Unlike the above-mentioned PLD-based actions, negligence claims require the establishment of some fault on the part of the manufacturer and/or defendant party. The elements of this claim are determined by the member state laws that apply.

Liability in Contract

Liability in contract can be claimed under the Consumer Sales and Guarantees Directive (1999/44/EEC) where a seller, that is “any natural or legal person who, under contract, sells consumer goods in the course of his trade, business, or profession” sells a product that does not conform to the contract of sale.

The PLD and Negligence Claims

The rules for determining whether the jurisdiction of EU courts is triggered, and, if so, which courts (in terms of which member state), in respect of the PLD and/or negligence claims are notoriously complex.

Regulation (EC) 864/2007 on the law applicable to non-contractual obligations (Rome Regulation II), provides the following parameters to help determine in which EU court the claim can be validly brought (on the proviso the product was marketed in that country):

• the “habitual residence” of the person bringing the claim and/or the person against whom the claim is brought;
• the location where the product was acquired; and
• the location where the damage was sustained.

Contractual Claims

For contractual claims, unlike the above-mentioned PLD and negligence claims, choice of law/forum is usually a feature of any contractual agreement, such that the above laws are not relevant. However, in the absence of such common contractual provisions, Regulation (EC) 593/2008 on the law applicable to contractual obligations (Rome I Regulation) can apply to product liability matters. Generally, the requirement under this law provides that “a contract for a sale of goods shall be governed by the law of the country where the seller has ‘habitual residence’.” This requirement supplements any country-specific requirements in that regard.

Jurisdiction

Given the complexity of these regimes, careful legal analysis must be deployed to ensure the correct jurisdiction of the claim applies, as this can often be the determining factor of whether a claim succeeds or fails.

Regulation (EU) 1215/2012 of the European Parliament and of the council on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (Recast Brussels Regulation) regulates jurisdiction and the recognition and enforcement of judgments between EU member states.

The laws of the member state in which any product liability claim is brought will determine the mechanism for payment of costs.

The general rule across most member states in the EU is that the costs of legal proceedings are awarded to the successful party in an action, with some exceptions. This essentially means that the loser will have to pay the legal costs associated with an action of their opponent.

However, in more complex litigation, and depending on the circumstances of the case, if either party to an action succeeds with a portion of their claim, the costs may be divided. Indeed, specific jurisdictions (eg, Germany) provide that the costs of litigation are split between the parties according to each side’s success rate.

Equally, in exceptional circumstances, courts may decide not to order the unsuccessful party in litigation to pay the costs of the opposite side. Such procedural rules on costs will normally be found in the statutes or common law or a mixture of both.

In other member states, these rules are applied at the ultimate discretion of the judge and so the awarding of costs often varies on a case-by-case basis, although usually “costs will follow the event”; the event being the success or failure of the claim.

In certain EU countries, however, the level of costs which may be obtained from an opponent are capped.   

Procedures regarding offer-based determinations for payment of costs, such as Calderbank offers and court lodgements, also exist in some member states. Careful consideration needs to be used in determining the strategy for deployment of these mechanisms, given their direct impact on costs.

There are several other mechanisms available, dictated by member state laws and procedures, in relation to product safety and liability matters for medical devices and consumer healthcare products, including:

• judicial review mechanisms for decisions made by regulators;
• inquiries which involve product-related issues, such as when products and the failure of products allegedly relate to widespread incidents or similar; and
• coronial inquests where a product may be implicated in the death of one or more individuals.

There is currently no unified mechanism for mass tort litigation in member states of the EU. Rather, each country has its own specific procedures and rules in relation to mass litigation/collective redress with wide disparity between the quality of such systems across the member states. Some countries have a high functioning system of collective redress in mass harm situations, eg, the Netherlands and Denmark, while others, including Ireland, Cyprus, and Latvia, have a poorly functioning system with regards to actions for mass harm.

The Collective Redress Directive

However, over the last decade, the EC has worked towards providing the means by which all EU consumers can bring collective actions in respect of infringements of EU law, referred to as “collective redress”, and in December 2020, Directive (EU) 2020/1828, the Representative Actions Directive, came into force.

The Directive took effect on 25 June 2023 although several member states are behind schedule and are yet to progress with implementing the legislation at national level.

The Directive will supplement existing national procedural mechanisms aimed at the protection of collective consumer interests. This is intended to improve consumers’ access to justice and to facilitate redress where a number of consumers are victims of the same infringement of their rights.

It will mandate that a procedure for representative actions is available across the entirety of the EU and will introduce safeguards for the avoidance of abusive litigation and illegal practices. This will have a sizeable impact on jurisdictions with non-existent or poorly functioning systems for collective redress/mass tort litigation.

All member states generally recognise that resolving consumer disputes by way of alternative dispute resolution (ADR) is a faster and less expensive method of resolution than going to court, and as such have in-built mechanisms for either mandated or voluntary ADR.

A number of forms of ADR apply across member states, including:

• mediation;
• arbitration;
• conciliation;
• adjudication; and
• ombudsmen.

Certain member states have taken sectoral initiatives to promote ADR by:

• creating consultative authorities on ADR mechanisms;
• providing finance for ADR organisations; and
• disseminating information on ADR to the general public.

Conventional ADR mechanisms are not the subject of any specific general regulations in member states. The only provisions applied are the general provisions of contract law or specific provisions connected with the transaction agreements to which ADR bodies can lead.

The inter-relationship between product safety regulatory compliance and product liability claims remains a controversial topic in the EU. It appears relatively clear that compliance with mandatory product safety regimes does not provide a full defence for a product liability claim. However, whether product safety regulations were complied with can form a legitimate consideration in determining the validity of a product claim, particularly as it relates to legitimate expectations. This area is likely to be the focus of future consideration in Europe.

It is also important to remember, a breach of safety regulations can itself give rise to liability, in the form of sanctions or criminal charges.

There are no major policy development initiatives in relation to medical device product safety and liability not deal with elsewhere in this chapter.

There is significant EU-level policy development in areas of product safety and liability that will impact medical devices and consumer healthcare products. These policy positions are likely to result in imminent legislative reform. These matters are set out more fully in the EU Trends and Developments chapter in this guide.

Product Safety Law Review

Currently there is an EU-level review of key product safety and liability laws, which has been ongoing for several years, including by two EC expert groups.

In June 2021, the EC proposed revisions to the 20-year-old General Product Safety Directive (GPSD) by virtue of the General Product Safety Regulation (GPSR). The GPSR identifies various areas of improvement including market surveillance, product recalls, cybersecurity, online marketplaces, and new technologies such as connected products and artificial intelligence (AI), most of which are subject to separate pieces of draft EU legislation which are currently being considered in parallel to the GPSR. The GPSR entered into force on 12 June 2023.

As set out above, the EC is also considering reform of the EU PLD, the EU legislation on liability for defective products, so that it is suitable for the digital age and the circular economy.

Review of Health Data

The EC’s public consultation on a European Health Data Space (EHDS) closed in July 2021. The purpose of the proposed EHDS is to establish an EU-wide framework for the exchange and sharing of health data across member states, deploying AI and digital technologies where relevant.

On 3 May 2022, the EC launched its proposal for a regulation for the EHDS which includes a legal framework for the use of health data by the industry for better healthcare delivery, better research, policy making, and innovation, in particular through AI and machine learning technologies. It also supports individuals to take control of their own health data and enables the EU to make full use of the potential offered by the safe and secure exchange, use, and reuse of health data.

Health Technology Assessment (HTA) Reform

The Regulation on Health Technology Assessment was adopted by the European Parliament in December 2021. The HTA process is an evidence-based multi-disciplinary review of new technologies, which includes consideration of cost implications for patients and insurers alike. Currently, this review process is undertaken by in excess of 50 agencies across the EU. The Regulation, which comes after three years of difficult negotiations, is set to streamline this process and will strengthen co-operation between member states and improve the quality of services and availability of healthcare technologies, including medical devices.

Artificial Intelligence

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

The EC has also proposed to regulate AI. On 21 April 2021, the EC published its landmark proposal for a regulation laying down harmonised rules on AI with the first-ever legal framework on AI to address the risks and trustworthiness of AI. These laws will have direct impact on certain products within the medical devices and/or consumer healthcare product categories depending on the technology deployed. On 14 June 2023, members of the European Parliament adopted its negotiating position on the AI Act, paving way for further negotiations with EU member states on the final legislative text.

The EC has also published a proposal for a civil liability regime for AI, known as the AI Liability Directive, which, when enacted, will enable individuals who have been harmed by AI to sue the AI “provider”.

The proposed AI Act and AI Liability Directive are expected to work in tandem with other laws and regulations that govern the safety of new technologies, including the EU GPSR and the PLD.