Product Liability

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Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during February and early March 2025 from the United States, United Kingdom, and European Union.

Artificial intelligence (AI) has been the focus this month, with certain aspects of the EU AI Act now in force and key guidance being published by the European Commission. In addition, the much criticized AI Liability Directive has been withdrawn by the European Commission. In the UK, the UK government published its AI Action Plan setting out its proportionate, flexible regulatory approach towards AI, and the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an Innovation Showcase demonstrating how it is using digital technologies and AI throughout the regulatory lifecycle. Continue Reading Virtual and Digital Health Digest – March 2025

This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024  from United Kingdom, and European Union.

Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy agenda. Of particular importance to the life sciences sector are the Product Safety and Metrology Bill and the Digital Information and Smart Data Bill. Although the scope and content of each bill is currently unknown, they could impact medical devices and innovative scientific research. Further, there was no artificial intelligence bill in the agenda, although the government will “seek to establish the appropriate legislation” in the future.Continue Reading Virtual and Digital Health Digest – August 2024

Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.

The agenda includes a Product Safety and Metrology Bill.  Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI.  We set out below a brief summary of the Bill.Continue Reading The King’s Speech: Product Safety and Metrology Bill

Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Continue Reading Implications of the New EU Product Liability Directive

This digest covers key virtual and digital health regulatory and public policy developments during March.

You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product liability regime, including that software and artificial intelligence (AI) technologies will now fall within the scope of a product. On March 13, 2024, the EP formally adopted the Artificial Intelligence Act, meaning the legislative process for the world’s first binding law on AI is nearing its conclusion. Finally, on March 15, 2024, the Council of the European Union and the EP reached a provisional agreement on the European Health Data Space (EHDS), which aims to improve access to health data electronically across the EU. Each of these important legislative provisions should shortly be finalized and will then become law in the EU.Continue Reading Virtual and Digital Health Digest, April 2024

Spurred, in part, by the COVID-19 pandemic and the need for new ways to reach patients at home, 2023 saw a boom in digital technologies and healthcare solutions: one-stop-shop telemedicine platforms, app-based remote patient monitoring, direct-to-consumer online pharmacies, software-based medical devices, and artificial intelligence/machine learning to bolster delivery of telehealth services. Then came a robust government response. In the EU and UK, regulatory bodies grappled with the introduction of machine learning, AI, and other software into healthcare services by, for example, new guidance from the EU Medical Device Coordination Group and UK Medicines and Healthcare products Regulatory Agency on software medical devices, the EU’s AI Act and the UK government’s AI White paper, the European Medicines Agency reflection paper on use of AI in the product lifecycle, the EU Data Privacy Framework and the equivalent UK-U.S. data bridge, and the European Health Data Space. 

We call this the “Race to Regulate.” This push-pull dynamic between digital health innovation and government regulation is key to evaluating regulatory risks in today’s shifting legal landscape. This digest seeks to keep up with these changes and provide you with an overview of the key guidelines and developments as the landscape develops. As we come to the end of 2023 and publish our latest Digest, join us on December 13 as we unpack pivotal moments in the 2023 Race to Regulate and discuss what’s next for virtual and digital health. Continue Reading Virtual and Digital Health Digest and webinar

The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.Continue Reading UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.Continue Reading Medical Devices and Compulsory Insurance in the EU