We are pleased to announce the launch of our new online content hub, the Product Risk Radar. The hub includes the latest important legal developments in product regulatory and liability risk impacting the UK and EU and we will post regular updates to help you navigate this increasingly challenging landscape. The areas covered include regulatory requirements, product liability and market surveillance and general product safety.
On 30 March 2023, Members of the European Parliament endorsed proposed reforms to the General Product Safety Directive (GPSD) in the form of a Regulation, intended to safeguard consumers. This new Regulation looks set to be one of the most significant updates to the EU’s product regulatory landscape in modern history – making substantial amendments to the GPSD, which has been in force for more than two decades.
On 28 September 2022, the European Commission published its proposals for a new directive to replace the EU Product Liability Directive (85/374/EEC) (PLD). The new PLD was announced alongside a separate proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence that seeks to address challenges faced by victims of AI-related damage to make claims and receive compensation, and will interact with member states’ fault-based liability regimes (AI Liability Directive). The AI Liability Directive is not intended to overlap with the PLD.
The appellant in the case of Hastings (Appellant) v Finsbury Orthopaedics Ltd and another (Respondents) (Scotland)  UKSC 19, has failed to demonstrate to the UK Supreme Court (UKSC) that a prosthetic hip (manufactured by the respondents, each making separate parts) used in a metal-on-metal hip replacement was defective. Rather, the UKSC unanimously upheld the finding of the lower courts and concluded that the nature of the product meant that there could be no entitlement to an absolute level of safety.
The judgment is likely to be welcomed by those involved in the manufacture and distribution of medical devices and other health care products, as it continues the pragmatic approach of the UK courts in seeking to balance the need to achieve a high level of consumer protection against a robust assessment of the standards which the public can realistically expect manufacturers to achieve.
The Office for Product Safety and Standards (OPSS) published a report on 23 May 2022 which considered the impact of artificial intelligence (AI) on product safety.
The report provides a framework for considering the impact of AI consumer products on existing product safety and liability policy. This framework seeks to support the work of policymakers by highlighting the main considerations that should be taken into account when evaluating and developing product safety and liability policy for AI consumer products. No timeline is stated in the report for that evaluation/ development to take place, but the report makes clear the view that work is needed to ensure the UK’s product safety and liability regime can deal with AI developments.