Medical Devices & Consumer Health Products 2021

Last Updated August 31, 2021

EU

Law and Practice

Authors



Kennedys is a global law firm with expertise in dispute resolution and advisory services, and over 2,300 people in 24 countries around the world. It handles both contentious and non-contentious matters and provides a range of specialist legal services, including corporate and commercial advice, but with a particular focus on defending insurance and liability claims. Kennedys has unrivalled strength and depth of expertise, and it is one of the very small number of “go-to” firms whenever major and complex product safety, compliance and product liability claims arise, often involving cross-border litigation, regulatory issues or criminal investigation. The firm is currently handling product safety, compliance and liability matters across the EU, and globally. The 43 international offices and 25 co-operation and associated offices cover all major markets and work on high-profile products law cases.

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, whilst not stifling innovation.

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

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, these having to do with:

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

General product safety regime

This mandates overarching requirements for product safety of consumer products in the EU, and tends to operate where the aforementioned regimes and/or no more specific requirement has 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, both concepts are fundamental principles of the EU product safety system also.

Generally, these above-mentioned 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 that the product meets safety requirements (see 2.4 Marketing and Sales).
  • Record-keeping requirements, including creation of 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).
  • 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 is currently in the process of 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 are being 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 is in process of being repealed and 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).
  • 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).

Whilst the laws formerly applicable to medical devices (including implantable medical devices) have already been replaced by the newer form of the law. In May 2021, after a short delay of one year (the COVID-19 pandemic cited as the primary basis for this delay), the laws regarding in vitro medical devices come into full effect from May 2022.

Medical instruments

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

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 clinical trials are governed by a separate piece of legislation, Clinical Trial Directive (2001/20/EC), which is currently in the process of being replaced by the Clinical Trials Regulation (536/2014).

Blood products

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

Personal protective equipment

Generally medical personal protective equipment 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 other medical settings are classed as 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 Personal Protective Equipment Directive (2016/425).

There are a range of consumer products which are not medical in nature, but which may be related to health and wellbeing. 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 because of the growing trend towards health and wellbeing.

Cosmetics

Cosmetics in the EU are regulated under the Cosmetics Regulation (Regulation (EC) No 1223/2009). Such legislation often works in conjunction with other chemical regimes, including relevantly REACH and CLP.

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. Whist 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 Nutrition Supplements

Several different potentially applicable legislative regimes may apply to health food and nutrition supplements (nutraceuticals as they are sometimes called). There is no comprehensive system to cover these product categories, however. In the instances of some particular supplements or ingredients, including for example cannabis or CBD, such ingestible products containing these substances may be considered "novel foods" and come under the Novel Food 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 the 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 the supplements or food additives have a particular dietary purpose or target group, for example infants (infant formulae).

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, such that it is 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.

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

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

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). Therefore, the determination of which regime applies to a certain product is a fundamental determination. In many instances several regimes can apply; however, in other instances, applicable legislation can expressly exclude the operation of certain other legislative regimes.

Given the number of potentially 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, 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 produced in the context of the pandemic therefore, which significantly improved clarity in what, ultimately, remains a grey area.

Common Borderline Products

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), and 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 principle 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). 

Personal protective equipment and medical devices

As noted in 1.1 Medical Devices, medical personal protective equipment 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, that 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 biocides, such that the biocides regulatory regime applies.

There are certain requirements in relation to manufacturing and design of medical devices and consumer health products 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, for example:

  • medical devices, in which it is required to comply with a prescriptive set of requirements in relation to good manufacturing practices (GMPs) but also 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 alike, alongside 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 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).

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 are usually such that they can present the greatest safety risk (often being used in ways that are linked to health and/or in the context of disease or treatment of disease); and
  • given the important health consequences that may flow, it is particularly important 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 for cosmetics has the following bases:

  • 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 European Commission, which provides specific guidance and criteria on making claims; and
  • application of rules relating generally to advertising, marketing and unfair claims made to consumers.

Pre-market requirements, marketing authorisations and post-marketing obligations are key features of all product safety regimes in the EU, including as 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 necessitated by regulations also.

Pharmaceuticals

Clinical trials are required before marketing medicinal products in the EU to determine the safety and efficacy of pharmaceutical 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 kept (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 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 where 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 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 EMA, known as the EudraGMP.

Other regimes do not generally include a requirement for any sort of pre-market approval; however, there is a registration requirement 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 is most driven by their commercial incentives and imperatives.

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

The notion of "mutual recognition" throughout the EU is a driving force for 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.

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.

Furthermore, the need for local language requirements, 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. As, often, is the need for local language support for consumer complaints.

Alongside pre-market requirements, post-market 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-market surveillance system);
  • the appointment of a responsible person to ensure 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.

Notification to Regulatory Authorities

This involves, depending on the nature of the product in question, 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 authorities in the event a product is not compliant with the applicable product safety regime.

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 – both those that oversee and regulate general consumer products and 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; however, only in so much as regulators of specialist product categories have different ambits of work, but regulators are not layered in terms of oversight and there is generally a single layer of regulators.

Whilst 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 (European Medicines Agency, EMA) and chemicals (European Chemicals Agency, ECHA). Whilst these organisations do not typically get involved in actual enforcement practices, or authorisation processes, they do provide expert guidance and broader policy input. The European Commission 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 European Commission produces comprehensive guidance in respect of the medical devices regime, in the form of the MEDEEV guidance documents.

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

In general, 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 discrepant regulatory enforcement practices across the EU – and often resulted in the criticism that the enforcement of the EU product safety laws was a weak link in an otherwise sophisticated regime.

Against the above backdrop, there has been an increasing focus in recent years on increased enforcement practices, but also increased EU-wide enforcement practices for product safety generally, as part of the EU’s Goods Package. In particular, the new 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 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 range 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 generally can be divided into three main categories, as 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
  • "product" being defined broadly as “all moveables” 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;
  • 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 but not limited to the product’s presentation, its use, and the time it was put into circulation; and
  • a causal relationship between the damage and 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 in many instances, though not to the extent of amounting to a so-called class action in many 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.

Liability in the Tort of Negligence

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

Liability in Contract

Liability in contract can be made out 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 rules for determining whether the jurisdiction of EU courts are triggered, and if so which courts (in terms of which member state) in respect of 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.

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.

Given the complexity of these above regimes, careful legal analysis must be deployed to ensure the correct jurisdiction of the claims applies, as often this can 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) (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 Europe 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 (for example, 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 statute 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 award of costs often vary on a case-by-case basis, though 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, exist in some member states also. 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, for example;
  • inquiries which involve product-related issues, such as the alleged involvement of products and their failures as they relate to widespread incidents or similar; and
  • coronial inquests where a product may be implicated in the death of individual(s).

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 a 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, for example the Netherlands and Denmark, whilst others, including Ireland, Cyprus and Latvia have a poorly functioning system as regards actions for mass harm. 

Member states are, however, in the process of being required to implement into local laws an EU-wide collective redress regime. Directive (EU) 2020/1828, the Collective Redress Directive, will become effective across the EU in 2023 and 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. The Directive 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.

See 4.6 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.

There are a number of forms of ADR that may apply across member states. These include:

  • 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 by disseminating information to the general public on ADR.

Conventional ADR mechanisms are not the subject of any specific general regulations in the 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 interrelationship 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 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 (see 5.2 Legislative Reform for further detail of existing legislative change). These matters are set out more fully in the EU Trends & 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 European Commission Expert Groups.

Artificial Intelligence

On 21 April 2021, the European Commission published its proposal for a regulation laying down harmonised rules on artificial intelligence (AI) with the first ever legal framework on AI to address the risks and trustworthiness of AI. These laws could have direct impact on certain products within the medical devices and/or consumer healthcare product categories depending on the technology deployed. Guidance on the topic has yet to be produced by the medical devices expert group (MDEG) or the MDR/IVDR Borderline and Classification Group, to whom the task has been assigned. However, global guidance has been produced, including, relevantly by the WHO, in respect of ethical use of AI in health applications.

Review of Health Data

The European Commission’s public consultation on a European Health Data Space (EHDS) closed recently 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.

Health Technology Assessment(HTA) Reform

Recently, the Council of the European Union (the Council) and the European Parliament (the Parliament) have reached an agreement regarding a legislative regime for HTA. 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, in the EU, this review process is undertaken by in excess of 50 agencies across the EU. The proposal for regulation, which comes after three years of difficult negotiations, is set to streamline this process.

There is wide-ranging imminent legislative reform currently in progress in the EU in respect of product liability and safety laws as they apply to medical devices and consumer healthcare products as below. These are expanded on fully in the EU Trends & Developments chapter in this guide.

New Medical Devices Legislative Regime

On 26 May 2021, the new EU Medical Devices Regulation (EU) 2017/745 (MDR) became applicable and brought EU legislation into line with new technical advances in medical devices and changes in medical science.

Against the backdrop of perceived historical issues with medical device safety in Europe generally, the new laws aim to create a more robust, transparent, and sustainable regulatory framework, to improve clinical safety and to create fair market access for manufacturers and healthcare professionals.

There are still several applicable transition periods that apply in respect of the legislation, including, relevantly, that manufacturers can place products on the market that are certified under the old regime, and to which no significant changes have been made, until 2024 and can provide these to end users until 2025.

Notified body appointments and guidance documents continue to be produced by EU bodies to help companies and industry grapple with the new legislation.

In Vitro Medical Devices Legislative Regime

Whilst the EU’s new legislative regime for medical devices has taken effect already, as above, the regime for in vitro medical devices is due to take effect in May 2022. Companies impacted by the legislation are advised to take immediate action to ensure compliance by this deadline.

Goods Package Legislation Implementation

Several pieces of legislation aimed at ramping up enforcement of product safety regimes in Europe, which has historically seen to be the weak link of otherwise robust product safety regimes, have been enacted, including in respect of market surveillance and enforcement practices.

Collective Redress Regime Implementation

An EU-wide mechanism to allow for collective redress/mass claims is likely to change the landscape for product liability in the EU. Member states are currently in the process of implementing this legislation, and national variances are being keenly noted and observed by those affected by the new legislation. Please refer to 4.6 Mass Tort Litigation for further details.

Digital COVID Pass Regulation

The Regulation for an EU Digital COVID Pass has been in effect since July 2021. The pass provides proof of EU-based vaccination and can be used for travel purposes and other purposes.

The impact of Brexit has been felt in respect of regulation of medical devices and consumer healthcare products; in particular, as set out below. These issues are considered more fully in the EU Trends & Developments chapter in this guide.

Medical Devices

Given the timing of the implementation of the new EU medical devices regime, the UK retains the former version of the EU laws on medical devices whereas the EU has pressed forward with the new legislative suite. This is one area, therefore, where there is immediate divergence of laws for product safety between the EU and UK. This is an area to be watched closely therefore, both in terms of monitoring dual requirements for compliance but also in terms of the likely policy around divergence between the two regions.

Cosmetics

Given the requirement for maintenance of a PIF and the existence of a responsible person within the EU, the exit of the UK from the EU has meant that actors in the supply chain in the UK who were previously distributors now likely find themselves importers to the UK, with considerably increased compliance obligations. This issue may have implications for EU-based entities also, in so much as manufacturing or importation into the EU was previously through the UK.

The COVID-19 pandemic has resulted in an unprecedented impact of medical devices and consumer products, given the role of these industries and products in the fight against COVID-19 in terms of prevention, treatment and protection against the coronavirus. These issues are considered more fully in the EU Trends & Developments chapter in this guide.

Some examples of the high-level impacts of the pandemic on industry are as follows.

Industry-Wide Changes

These include:

  • increased demand for the rapid production of specific products, such as diagnostic tests, vaccines, treatments and personal protective wear;
  • entry of new players into the market, including those that are sophisticated in other areas of manufacture but that had not been involved in the market previously;
  • changes to processes and practices undertaken in industry to account for working from home circumstances and disrupted supply chains;
  • an increased use of emerging technologies such as genomics, telehealth and AI in the drug discovery process to accommodate the new normal of remote working during COVID-19; and
  • a heightened risk of cybersecurity cases involving potential software data breaches in respect of COVID-related tracking practices.

Consumer/Patient Behaviours

The increase in home-grown products and technologies by EU-based producers may give rise to liability exposure in unanticipated circumstances.

There is also an emerging trend towards more online marketplaces, and consumer purchases of non-compliant products or products not intended for their markets.

Regulator Actions

The pandemic prompted a proliferation of guidance, exemptions and derogations provided by regulators, in particular life sciences regulators, including the granting of exemptions, derogations and expedited pathways, notably 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.

Government Actions

Also of note were grants 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.

Kennedys

Bloodstone Building
Sir John Rogerson's Quay
Dublin D02 KF24
Ireland

+44 20 7667 9677

+353 1 878 0055

sarah-jane.dobson@kennedyslaw.com www.kennedyslaw.com
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Trends and Developments


Authors



Kennedys is a global law firm with expertise in dispute resolution and advisory services, and over 2,300 people in 24 countries around the world. It handles both contentious and non-contentious matters and provides a range of specialist legal services, including corporate and commercial advice, but with a particular focus on defending insurance and liability claims. Kennedys has unrivalled strength and depth of expertise, and it is one of the very small number of “go-to” firms whenever major and complex product safety, compliance and product liability claims arise, often involving cross-border litigation, regulatory issues or criminal investigation. The firm is currently handling product safety, compliance and liability matters across the EU, and globally. The 43 international offices and 25 co-operation and associated offices cover all major markets and work on high-profile products law cases.

The medical devices and healthcare industry in the EU has undergone significant change in the last few years. Some changes have been the result of years of considered thought, meticulous review and attempted betterment of existing legislative regimes. Other change has been brought in rapidly, unexpectedly as a reaction to recent world events, including most relevantly the COVID-19 pandemic.

Overall, these changes have arguably only served to galvanise the EU’s large and growing medical devices and healthcare products industries, the former estimated by the European Commission in 2019 to be comprised of 500,000 different types of medical devices and worth EUR100 billion, as a pillar of modern EU society.

Medical Devices Legislative Regime Overhaul

Arguably, the most profound change in most recent years has been the overhaul of the EU’s medical devices regime. The creation of modern-day medical devices regime has the following history.

In the 1970s, member states relied on their own national medical devices regimes, which focused on product registration but did not include concepts of product safety or manufacturing practices. The result was a patchwork of very divergent laws.

Shortly thereafter, an EU-wide approach to product safety regimes, including that applying to medical devices, was adopted (the "Old Approach"). This legislation included pan-European legislation that included concepts of technical and administrative requirements for products in prescriptive detail.

In 1985, the creation of the "New Approach" EU-wide legislation, where only the "essential requirements" for product safety were contained within regulations, and third party "notified bodies" and prescriptive, detailed technical requirements were provided for.

In 2008, the "New Legislative Framework" approach further refined the above and technical standards were key features of the legislative framework, with an increased focus on the standardisation process to capture key technical requirements.

For a significant period of time, the mainstay medical devices legislative regime in the EU comprised the following pieces of legislation, implemented by member states into national legislation:

  • 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).

As early as 2012, an overhaul of the EU’s mainstay medical devices regime was contemplated. The changes were prompted following a series of high-profile instances of litigation, and extensive investigations relating to the manufacture and sale of medical devices in the EU. Legislatures therefore decided to change the existing legislative framework to reflect the learnings of those incidents. The target of reform was to reduce the inability of those who suffered damage as a result of defective products to obtain compensation due to the bankruptcy of companies involved in the product’s manufacture. For this reason, it addressed what was thought to be the excessive frequency of medical device manufacturer companies going bankrupt, resulting in the inability of any parties who had suffered damages as a result of defective products to obtain compensation as well as the shortcomings of the notified bodies that were charged with overseeing technical compliance aspects of product safety.

As a result of these findings, in September 2012 the European Commission proposed new legislation to regulate medical devices, including in vitro medical devices. By April 2017, the new regulations were adopted and subsequently published in the EU’s Official Journal. Following a transition period – and an extension of the same due to delays related to COVID-19 as well as a recognition of the lack of preparedness of the frameworks on which the new regulations were reliant (including in respect of redesignation of notified bodes and/or EUDAMED database preparedness) – aspects of the law that apply to medical devices became applicable in May 2021, and the same will be true for in vitro medical devices in May 2022.

The new legislative regime is made up of the following pieces of legislation, which have direct effect in member states, after applicable transition periods:

  • 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).

On 26 May 2021, the new EU Medical Devices Regulation (EU) 2017/745 (MDR) became applicable and brought EU legislation into line with new technical advances in medical devices and changes in medical science.

There are still several applicable transition periods that apply in respect of the legislation, including, relevantly, that manufacturers can place products on the market that are certified under the old regime, and to which no significant changes have been made, until 2024 and can provide these to end users until 2025.

Notified body appointments and guidance documents continue to be produced by EU bodies to help companies and the broader industry grapple with the new legislation.

The current new legislative framework governing the manufacture and supply of medical devices and healthcare products, in common with prior legislation, is guided by two key principles, which have been strengthened and emphasised over 40 years of legislative history.

  • Only safe and products that comply with the prescriptive regime can be marketed in the EU, to ensure the safety of consumers and users and to ensure a fair market is established to encourage responsible economic operators and minimise rogue traders.
  • There must be free movement of goods, without trade barriers, within the single market, and products marketed and sold across the EU benefit from mutual recognition whereby a product recognised as compliant in one member state will automatically be considered compliant in another member state.

The newer regime has the following key features which are thought to improve upon the older system:

  • revision of risk-based classification system for in vitro medical devices;
  • improved co-ordination between EU authorities;
  • broadening of scope of medical devices legislation, to include aesthetic devices;
  • creation of EU-wide medical devices database which includes key details for traceability;
  • more stringent requirements for pre-marketing compliance, including the involvement of a pool of experts at EU level;
  • creation of an "implant card" for patients;
  • more stringent requirements for clinical investigations;
  • increased post-market surveillance obligations; and
  • increased focus on new technologies, including in relation to cybersecurity in particular.

Whilst the EU’s new legislative regime for medical devices has taken effect already, as above, the regime for in vitro medical devices is due to take place in May 2022. Companies impacted by the legislation are advised to take immediate action to ensure compliance by this deadline.

Focus on Newer Technologies and Cybersecurity in Respect of Medical Devices

The medical devices and consumer health industries have, for a long time, been leading the EU-wide policy drive for consideration of newer technologies in product safety regimes.

The concept of software as a product and the importance of cybersecurity as a key consideration of product safety have been firmly enshrined in medical device legislation for some time in the EU, whilst they are still being grappled with, and only now being addressed head-on with proposed changes, in mainstream product safety legislation in the EU.

Given the above-mentioned increased focus on newer technologies in the new EU medical devices regime, the European Commission, immediately prior to the pandemic, also produced detailed guidance on the topic of medical devices and cybersecurity. The guidance seeks to further explain new essential requirements for safety for devices that incorporate electronic programmable systems and software that is itself a medical device. It is clear that manufacturers now have an obligation (i) to develop and manufacture products taking into account information security risks and IT security issues, and (ii) to protect against unauthorised access.

Earlier this year the European Commission published its proposal for a regulation laying down harmonised rules on artificial intelligence (AI) with the first ever legal framework on AI to address the risks and trustworthiness of AI. These laws could have a direct impact on certain products within the medical devices and/or consumer healthcare product categories depending on the technology deployed. Guidance on the topic has yet to be produced by the medical devices expert group (MDEG) or the MDR/IVDR Borderline and Classification Group, to whom the task has been assigned. However, global guidance has been produced, including, relevantly by the WHO, in respect of ethical use of AI in health applications.

Recently, the Council of the European Union (the Council) and the European Parliament (the Parliament) have reached an agreement regarding a legislative regime for the Health Technology Assessment (HTA). 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, in the EU, this review process is undertaken by in excess of 50 agencies across the EU. The proposal for regulation, which comes after three years of difficult negotiations, is set to streamline this process.

Responses to COVID-19 by Medical Device and Healthcare Regulators

Whilst the effects of the COVID-19 pandemic have been felt universally, across a broad range of industries, the impact on medical devices and healthcare products has been particularly profound and immediate.

Although there are many remarkable things that have occurred during the height of the crisis, the actions of EU medical device and healthcare product regulators has been particularly unprecedented. The pandemic placed a spotlight on the industry and increased pressure on companies and regulators alike to maintain high levels of product safety whilst effectively and quickly mobilising the industry, as key actors in the pandemic at every stage – from prevention (hand sanitisers and masks) to detection (PCR and rapid antigen tests) and protection (vaccinations) to treatments (medicines and the like). Regulators deployed a range of tools, including the following main types of actions.

  • Providing comprehensive and specific guidance including, particularly, in respect of conformity assessment procedure choices in certain circumstances, the borderline distinction between PPE and medical devices and choice of technical standards. Third parties also made relevant technical standards free of charge.
  • Allowing certain derogations and/or granting exemptions from key aspects of the existing product regulatory regime, including, in particular, maintaining a relaxed approach to clinical investigation requirements for COVID-19 specific devices, allowing remote auditing for medical devices in certain circumstances, expediting certain clinical investigations for COVID-19 products, and preventing shortages of critical medical devices by allowing temporary derogations for Notified Body audits.
  • Implementing broader, far-reaching changes that are not directly related to the pandemic, but which allow increased focus of industries on the fight against COVID-19. This includes the aforementioned delay of implementation of the EU’s new medical devices regulatory regime, from May 2020 to May 2021, with the pandemic (and the industry’s understandable preoccupation with the issue) given as one reason for the delay.

The above practices by regulators were wide-spread and considerable; however, these changes are generally specific, defined and temporary in nature.

The above-mentioned actions taken by regulators have been in parallel with the actions taken by governments within member states, including in relation to indemnification of manufacturers making COVID-19 products in some limited circumstances or otherwise considering the implementation of a compensation scheme for those negatively impacted by any issues caused by COVID-19 products.

In light of the regulators' response, as described above, companies, supply chain actors and insurers need to keep up to date with the ever-changing regulatory framework, including reviewing and assessing the ongoing compliance of products that relied on temporary derogations or exemptions. Long-term consideration of resultant product liability exposure is also recommended, so as 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.

CBD-Containing Non-medicinal Products

In addition to the existing medical uses for CBD and cannabis, the use of cannabis and CBD in all forms of products is on the rise across the EU. Indeed, EU markets are now flooded with CBD-containing cosmetics and foods and drinks, amongst other product categories.

There have been considerable hurdles in respect of the marketing of these products, particularly those incorporated into food or drinks.

Since January 2019, CBD has been considered a "novel food" under EU Regulation 2015/2283. Where a food is defined as such, safety assessments must be undertaken and the product must be authorised before entering the EU market.

Food regulatory bodies across the EU acted on the classification of CBD as a novel food in a wide variety of ways. Spain and Austria have removed CBD food and drink products from their markets entirely until they receive the requisite novel foods authorisation, whereas the UK (which was still a member state at the time) permitted the ongoing sale CBD products that existed on the UK market in January 2019 until 31 March 2021.

In July 2020, the European Commission paused all ongoing novel food applications in respect of CBD-containing products. There were concerns that, regardless of compliance with applicable regulatory frameworks, such products may violate criminal laws. The basis for this concern was that CBD may constitute "an extract of cannabis" and may therefore be considered a "drug" as defined by the UN Single Convention on Narcotic Drugs 1961.

On 19 November 2020, the EU CJEU ruled that CBD cannot be regarded as a narcotic under the 1961 UN Convention given that current scientific knowledge does not suggest that CBD contains psychoactive ingredients.

Following the ruling, and the regulators’ resumption of processing applications, over 50 companies that had applied to register their products as novel foods within the EU were able to resume their applications to market their CBD products.

In some member states (including France), there has been litigation about CBD products following the CJEU’s 2020 court decision, as governments are grappling with these products.

Food and Supplements Technological Advancements

In an age of technological advances, use of newer technologies that are thought to be more environmentally friendly and sustainable in the long term, is being considered by legislatures – including in the form of a comprehensive review of legislation that applies to the regulation of genetically modified organisms (GMOs), particularly in food chains.

Most recently, in April 2021, the European Commission published a study regarding the status of new genomic techniques (NGTs) under EU laws, with the Commission recognising that it is a fast-moving and promising area. Key findings of the study included the following.

  • There are implementation and enforcement issues under existing EU regulatory regimes, particularly in relation to the differentiation between NGTs that do and do not contain foreign genetic material. These are thought to currently be prohibitive to an increased use of these technologies.
  • NGTs are thought to have the potential to contribute to sustainable food systems and encapsulate ideals espoused by EU policy on this point, including the Green Deal, and should therefore be a focus of attention for regulatory overhaul in the near future.
  • There is potential application of these technologies for medical needs which should be further explored.

Corporate Social Responsibility and Environmental Considerations

As a trend that has been taking place for many years, including at an EU-level for all product safety areas in the EU’s Green Deal, policy changes and guidance in respect of the medical device and healthcare industry continue to focus on corporate social responsibility, sustainability and environmental considerations. Manufacturers should be prepared for this to continue in the long term and even expand further as these topics impact on all aspects of the manufacturing processes. 

Biocidal Products Regulation Regime

Given the focus on the biocidal products regime that the COVID-19 pandemic caused, as a result of many companies that were very sophisticated in other parallel regimes, such as chemicals and/or cosmetics, having trouble navigating the fragmented system that was prohibitive on EU-wide sales, there is growing criticism of the lack of EU-wide harmonisation of this system, which some consider to be out of step with the general nature of EU product safety regulations.

Collective Redress Regime

The much-talked-about collective redress regimes to bring about US-style "class actions", including in respect of consumer law issues specifically, are poised to change the product liability landscape across Europe, with the EU Directive on representative actions having now come into force. Given the general trend for group actions focusing on medical devices and healthcare products, as opposed to consumer products in general, it is highly likely this new regime will be adopted for large-scale product liability cases in respect of medical devices in the near future. Member states are currently in the process of implementing the EU-derived laws into national mechanisms. Variations are already apparent, and should be keenly monitored going forward by all interested stakeholders (Please see Chambers' imminent Collective Redress & Class Actions guide).

Kennedys

25 Fenchurch Avenue
London
EC3M 5AD
UK

+44 20 7667 9677

sarah-jane.dobson@kennedyslaw.com www.kennedyslaw.com
Author Business Card

Law and Practice

Authors



Kennedys is a global law firm with expertise in dispute resolution and advisory services, and over 2,300 people in 24 countries around the world. It handles both contentious and non-contentious matters and provides a range of specialist legal services, including corporate and commercial advice, but with a particular focus on defending insurance and liability claims. Kennedys has unrivalled strength and depth of expertise, and it is one of the very small number of “go-to” firms whenever major and complex product safety, compliance and product liability claims arise, often involving cross-border litigation, regulatory issues or criminal investigation. The firm is currently handling product safety, compliance and liability matters across the EU, and globally. The 43 international offices and 25 co-operation and associated offices cover all major markets and work on high-profile products law cases.

Trends and Development

Authors



Kennedys is a global law firm with expertise in dispute resolution and advisory services, and over 2,300 people in 24 countries around the world. It handles both contentious and non-contentious matters and provides a range of specialist legal services, including corporate and commercial advice, but with a particular focus on defending insurance and liability claims. Kennedys has unrivalled strength and depth of expertise, and it is one of the very small number of “go-to” firms whenever major and complex product safety, compliance and product liability claims arise, often involving cross-border litigation, regulatory issues or criminal investigation. The firm is currently handling product safety, compliance and liability matters across the EU, and globally. The 43 international offices and 25 co-operation and associated offices cover all major markets and work on high-profile products law cases.

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