Farr, N.T.H. orcid.org/0000-0001-6761-3600, Owen, E.J. orcid.org/0000-0002-1850-2645 and Bhalekar, R.M. orcid.org/0000-0002-5230-719X (2025) UK consumer protection and the debate for reform in medical device liability. Laws, 15 (1). 1. ISSN: 2075-471X
Abstract
The long-stop rule, under the UK Consumer Protection Act (CPA) 1987, imposes a 10-year limitation period for product liability claims, providing legal certainty for manufacturers and consumers. However, this timeframe is increasingly problematic in the case of medical devices, particularly implantable ones, which can fail decades after implantation. This review considers an extension to the long-stop period for medical devices, emphasising the need for patient protection, legal clarity, and reduced clinician burden, and contrasts the current UK system with the EU’s proposed 25-year long-stop period under the recently implemented 2024 Product Liability Directive. Through case studies, including surgical mesh and orthopaedic implants, the discussion highlights the challenges posed by delayed failure modes and the resulting difficulties in seeking redress within the 10-year window. Lastly, the role of publicly funded redress schemes and the evolving legal landscape are examined, underscoring the importance of reconsidering the current statutory limitations. Extending the long-stop period, combined with the use of explant analysis to evaluate defective medical devices, is proposed as a means to enhance patient safety and align with ongoing advancements in medical technology and regulation.
Metadata
| Item Type: | Article |
|---|---|
| Authors/Creators: |
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| Copyright, Publisher and Additional Information: | © 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. (https://creativecommons.org/licenses/by/4.0/) |
| Keywords: | EU Product Liability Directive; UK Consumer Protection Act; long-stop period extension; medical device regulation; liability reform; explant analysis |
| Dates: |
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| Institution: | The University of Sheffield |
| Academic Units: | The University of Sheffield > Faculty of Engineering (Sheffield) > School of Chemical, Materials and Biological Engineering |
| Date Deposited: | 23 Dec 2025 08:44 |
| Last Modified: | 23 Dec 2025 08:44 |
| Status: | Published |
| Publisher: | MDPI AG |
| Refereed: | Yes |
| Identification Number: | 10.3390/laws15010001 |
| Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:235883 |
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