Healthcare: Medical Devices 2025

International Overview

This global guide is designed to support stakeholders in navigating the complex and ever-evolving landscape of product safety and liability, particularly in the context of medical devices and consumer health products. By offering a detailed, country-by-country analysis of relevant legal frameworks, recent developments and guidance on high-risk activities, the guide provides a comprehensive resource for understanding the challenges and opportunities in this sector.

As you explore the country-specific chapters, you will notice both commonalities and significant differences in how various jurisdictions approach the regulation and liability of medical devices and consumer health products. While many other product regulatory regimes have historically diverged across the world, in this space there is a clear trend towards greater global alignment, especially as innovation, emerging technologies and large-scale product liability claims become universal concerns.

1. Applicable Product Safety Regulatory Regimes

The consumer health products industry has always been a leader in innovation, and recent global events – most notably the pandemic – have accelerated the pace of technological advancement. This has prompted rapid and far-reaching changes to the regulation of medical devices and consumer health products, driven not only by legislative focus but also by the impact of geopolitical events such as Brexit and natural disasters.

The scope of products falling under consumer health product regulatory regimes continues to expand, reflecting modern preferences for health, wellness and ethical production. This has ushered in a new era for the industry, which now represents an even more significant and rapidly growing global market.

Regulation across major jurisdictions is fundamentally risk-based: higher-risk products are subject to more stringent controls. Distinct, product-specific regimes govern medical devices, medicines, cosmetics, biocides and food supplements. The EU and its member states, along with Switzerland, have harmonised or closely aligned frameworks, primarily based on the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In contrast, the UK, China and India have their own systems, with the UK diverging significantly immediately since the official date of Brexit.

A central principle in all systems is the focus on a product’s intended use and mode of action, which determine its classification – especially for borderline products that could fall under multiple regimes (for example, a product that could be classified as either a medical device or a medicine, or as either a cosmetic or a biocide). As such, careful, expert analysis is required on a case-by-case basis to determine the applicable regulatory obligations from the outset.

Digital health technologies, including medical software, apps and AI-based products, are increasingly regulated as medical devices if they serve a medical purpose. The EU is at the forefront with its AI Act (Regulation (EU) 2024/1689), while the UK is pursuing a more flexible, innovation-friendly approach.

2. Commercialisation and Product Life Cycle

The legal framework addressing the commercialisation and product life cycle of medical devices and related healthcare products follows broadly similar structures across major jurisdictions, though the details can vary significantly. The process typically begins with rigorous pre-market safety checks and conformity assessments, often involving third-party bodies, to ensure compliance with technical and safety standards. Manufacturers must prepare comprehensive technical documentation and, depending on the product’s risk classification, may need to obtain registration or marketing authorisation from the relevant regulatory authority.

Once a product is on the market, ongoing post-market surveillance is generally mandatory. This includes monitoring safety and performance, reporting adverse events and, where necessary, initiating recalls or corrective actions to protect patient safety.

Despite these shared foundations, there are notable differences in implementation of this legal framework across the world. The EU, for example, operates a system of mutual recognition, allowing products approved in one member state to be marketed across the single market, provided they meet harmonised EU standards and bear the CE mark. The UK, post-Brexit, now often requires separate compliance with UK-specific regulations and the use of the UKCA mark for products placed on the UK market.

Other differences include the authorities responsible for oversight, the specifics of conformity assessment procedures, and requirements for local language labelling and representation. Some countries require product information and labelling in the local language and mandate the appointment of a local representative for foreign manufacturers.

Sector-specific rules add further complexity, as medical devices, pharmaceuticals, cosmetics, biocides and food supplements are each subject to their own detailed regulatory regimes.

Regulators are increasingly focused on the issue of “greenwashing”, the practice of making misleading environmental claims to influence consumer purchasing decisions. This is particularly relevant to claims about recyclability, which have come under scrutiny from multiple regulatory bodies, including product safety and competition authorities, especially in the UK. There is also a growing emphasis on environmental and social governance compliance obligations for companies involved in product sales.

3. Regulator Engagement and Enforcement

The enforcement regime for medical devices is marked by strict oversight and severe penalties for non-compliance. Companies must establish robust post-market surveillance systems and be prepared for active regulatory scrutiny throughout the product life cycle.

Specialised national authorities such as the MHRA (UK), BfArM (Germany), Swissmedic (Switzerland) and NMPA (China) oversee compliance with medical device laws. In federal systems like those of Germany and Switzerland, regional or local authorities also play a significant role in inspections and other relevant product non-conformities associated with the commercialisation of health products, working alongside national agencies to ensure compliance.

Each jurisdiction, including EU member states, has its own enforcement and penalty systems for breaches of regulatory requirements. Manufacturers are required to report serious incidents and initiate recalls when necessary. Violations of medical device regulations can result in substantial administrative fines and, in severe cases, criminal penalties.

4. Liability

The jurisdictions covered in this guide generally operate strict liability regimes for defective medical devices. Until now, notoriously, the most difficult aspect for claimants in product liability cases has been proving the “causal link” between the alleged defective medical product and the harm suffered, although some jurisdictions offer certain relaxations or relief regarding the burden of proof.

Reflecting a global trend towards stronger consumer protection, the EU has recently reformed its Product Liability Directive (PLD), which had remained unchanged since its introduction in 1985. The updated PLD, adopted in October 2024 and required to be implemented by Member States by 9 December 2026, aims to address these existing potential issues with the framework as well as addressing the challenges posed by new technologies. To do the latter, the PLD expands the scope of liable parties, introduces disclosure obligations, eases the evidentiary burden for claimants, and updates definitions of product and damage to reflect digital and technological developments. in particular AI. All stakeholders involved in the production and distribution chain should ensure that they are fully prepared to meet the new requirements by this deadline at the latest.

In addition to strict product liability under the PLD, claimants may pursue claims for defective products under contract or tort (negligence), particularly where limitation periods for tortious claims are longer or where certain types of damages are not covered by the strict regime.

The so-called EU AI Liability Directive (AILD) was withdrawn from the legislative process in February 2025 because the EU Member States could not reach a sufficient consensus. The aim was to complement the EU AI Act by creating a harmonised system at the European level for damages caused by AI. Among other things, the draft included special rules of evidence and presumptions in order to relieve injured parties of the “black box” effect that typically hinders liability claims. For manufacturers of AI systems, this retraction of the legal framework in this space is not necessarily welcome news. Whilst the AILD would have provided a high degree of legal certainty regarding liability and harmonisation within the EU, the liability of manufacturers now falls back on the general PLD (and the transposing national laws), which has, however, been reformed to better address AI systems. However, this very argument was the very reason for the AILD withdrawal, in that the critics argued that the AILD became unnecessary and that the subject matter is already sufficiently regulated in the reformed PLD, which now includes software and the AI Act.

Besides the PLD reform, other recent country-specific reforms have made it easier for consumers to bring large-scale legal actions, including mass tort claims across different EU jurisdictions. As a result, medical devices and consumer health products are increasingly subject to collective redress or class action claims. Medical devices, in particular, are often at the forefront of mass tort litigation, given the potentially severe consequences of product failures and the complexity of the regulatory regimes that govern them.

5. Policy Development and Legislative Reform

Medical device laws have long drawn on concepts from data privacy and cybersecurity, a trend that has intensified with the implementation of the new EU medical device legislative suite, which has an increased focus on concepts such as IT security and related risks and emphasises the classification of medical device software in some instances.

In the UK, Brexit has significantly complicated the regulation of these product categories. Despite the “copy and paste” approach taken by the UK to most of its EU-based sources of law, given the timing of the EU’s long-awaited overhaul of its medical device product safety regulatory regime, medical devices is one area of law in which the EU and UK positions began to diverge almost immediately post-Brexit.

As of 16 June 2025, the UK has implemented its first major overhaul of medical device regulation, introducing new post-market surveillance regulations. These require manufacturers to actively monitor the safety and performance of their devices after they have been placed on the market, collect and assess real-world data, report serious incidents more quickly, and provide periodic safety update reports. The new rules apply to all UKCA- and CE-marked devices, including in vitro diagnostic devices and active implantable devices, placed on the Great Britain market after 16 June 2025. There are also new requirements for trend reporting and clearer duties for risk mitigation and communication with users.

Companies exporting globally must navigate a complex web of differing legal requirements.

AI is rapidly transforming the medical device sector internationally, enabling advanced diagnostics, personalised therapies and automation of complex healthcare processes. AI-powered devices can analyse vast amounts of data, support clinical decision-making, and adapt or “learn” after deployment, leading to improved patient outcomes and more efficient healthcare delivery. However, this also introduces new layers of regulatory, technical and ethical challenges for manufacturers, increasing compliance costs and complicating product development and market access.

The integration of AI into medical devices presents significant regulatory challenges, albeit one that the industry has been tackling for a long time, well in advance of many other product categories that are only now having to engage with it. The EU has taken a leading role with the recently adopted AI Act, which introduces a risk-based approach to AI regulation. High-risk systems, including most AI-driven medical devices, are subject to strict requirements. The Act works in tandem with the MDR and IVDR. This means that AI-based medical devices must comply with both sets of rules, requiring conformity assessments, technical documentation and ongoing risk management.

Manufacturers face not only new regulatory and liability challenges but also political ones. In June 2025, the EU prohibited companies originating in China from bidding on certain public medical device contracts over EUR5 million, using its International Procurement Instrument for the first time. Bidders from outside China may still include medical devices originating in China in their offers, provided that the value of these Chinese-origin products does not exceed 50% of the total contract value. In response, China is restricting certain medical devices from the EU from government procurements over CNY45 million (around EUR5.3 million). These steps point to an escalating trade tensions between the two regions in this industry.

In summary, the regulatory landscape for medical devices and consumer health products is becoming increasingly complex and dynamic, shaped by technological innovation, evolving legal frameworks and shifting geopolitical realities. Stakeholders must remain vigilant and adaptable to ensure compliance and manage risk in this challenging environment.