Products | UK Regulatory Outlook October 2022

Revised Product Liability Directive adopted by Commission

On 28 September, the European Commission announced the adoption of two new proposals to adapt new liability rules for products and artificial intelligence (AI). These aim to ensure that liability rules are fit for purpose and make it easier for consumers to bring claims related to modern technologies and their associated products.

With digital products continually developing and businesses looking to invest in innovative technologies, these revised rules are intended to provide legal certainty on their liabilities and what is considered a "defect". The rules are also intended to ensure that victims can get fair compensation when defective products, including digital and refurbished products, cause harm.

The proposal for the revised product liability directive will entirely replace the existing product liability framework, dating from 1985, and aims to: 

• Modernise liability rules for circular economy business models: the current legal framework has led to inconsistences and legal uncertainty, notably with the meaning of the term "product".  Liability rules need to be clear and fair for companies that substantially modify products.
• Modernise liability rules for products in the digital age: as products continue to develop and evolve with the use of advanced technology, these new rules will allow compensation for damage when connected products like drones are made unsafe by software updates, AI or digital services that are needed to operate the product, as well as when manufacturers fail to address cybersecurity vulnerabilities.
• Create a more level playing field between EU and non-EU manufacturers: for manufacturers based outside the EU, consumers will be able to claim compensation from an importer or the manufacturer's EU representative for compensation if they are injured by their defected products.
• Put consumers on an equal footing with manufacturers: the new directive will require manufacturers to disclose evidence (Article 8) where a defective product has caused damage and also reduces the challenge of the burden of proof (Article 9) for victims in complex cases, such as those involving pharmaceuticals or AI (article 9(4)).

The second proposal, the AI Liability Directive, will harmonise certain rules for claims outside the scope of the new Product Liability Directive, such as claims from victims of AI-related damage. More on how the two directives will work together can be found in the Q&A document.

The Commission's proposal will need to be adopted by the European Parliament and the Council.  

The European Commission has also opened a feedback period on these proposals. Comments can be made until 28 November 2022.

Common charger law to come into force by end of 2024

On 4 October, the European Parliament Plenary adopted the new law on common chargers, which forms part of the EU's effort to reduce electronic waste in the EU and incentivise consumers to make more sustainable choices.

By the end of 2024, all mobile phones, tablets and cameras sold in the EU will have to be equipped with a USB Type-C charging port. These obligations will extend to laptops from 2026. Customers will also be able to decide whether they wish to purchase a new charging device with their new product. These new rule do not apply to products already placed on the union market.

The Council have, on 24 October, formally approved the Directive and the next stage is for it to be published in the EU Official Journal. It will enter into force 20 days after publication. Member States will then have 12 months to transpose the rules and 12 months after the transposition period ends to apply them.

European Commission to evaluate WEEE directive's fitness for purpose

The European Commission launched a call for evidence on 6 October. It is seeking feedback from stakeholders on whether the waste electrical and electronic equipment (WEEE) directive is still fit for purpose, assess any untapped potential, reduce burden, and come to a conclusion as to whether a review is needed. The directive was last evaluated and revised in 2012.

The issue of electrical waste is one that is high on the EU's agenda and, as set out in the supporting document, is now one of the fastest growing waste streams both in the EU and globally.

The evaluation of the directive will look to aspects that have been particular challenging:

• meeting the WEEE collection targets;
• ensuring the proper treatment of WEEE, and a related level playing field;
• applying the Extended Producer Responsibility requirements (in particular for online sales); and
• combating illegal activities and substandard practices in the whole WEEE management process.

Comments are to be made by 3 November 2022 and a public consultation will follow in Q3 of 2022, with the aim of the evaluation being completed by Q4 of 2023.

Consultation launched on the revision of EU rules on food contact materials

On 5 October, the European Commission launched a public consultation for a legislative proposal on a proposed EU food safety initiative.

The aim of the initiative is to modernise the rules on food contact materials to:

• ensure food safety and a high level of public health protection;
• reduce the presence and use of hazardous chemicals;
• take account of the latest science and technology; and
• support innovation and sustainability by promoting safe reusable and recyclable solutions, and help reduce the sector's environmental impact.

The ongoing evaluation of the current food contact materials legislation has found some fundamental issues, such as that the rules do not encourage development of safer and more sustainable alternatives, and also finding a lack of prioritisation of the most hazardous substances and up-to-date assessments.

The aim of this initiative, set out in the impact assessment, is to "build a comprehensive, future-proof and enforceable regulatory system for FCMs at EU level that fully ensures food safety and public health, guarantees effective functioning of the internal market and promotes sustainability."

Comments are to be made by 11 January 2023.

£1.8 million funding awarded to explore UK regulatory framework of digital mental health tools

Funding has recently been awarded to The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) to explore the regulation of digital mental health tools to ensure "certainty and safety" in this area.

With the £1.8 million of funding, the MHRA and NICE will be reviewing key aspects of the medical devices regulations in order to produce "risk appropriate" guidance to clarify areas such as what qualifies as a medical device and which risk classification they fall under. The MHRA will be engaging with patients, individuals and subject experts to gain an understanding of how they would like the regulatory framework to look.

The announcement highlighted that the outcome of this project will mean that "certain mental health software will be proportionately regulated as a medical device, meaning the public has access to effective and safe products that can significantly help protect or improve their mental health."

MHRA appoints first new UK Approved Body to certify medical devices since Brexit

The MHRA announced on 29 September that it has appointed DEKRA Certification UK Ltd as a new UK Approved Body, which is the first organisation to complete the new designation process that any potential organisation must now go through in order to become approved to certify medical devices in the UK.

This appointment will increase the UK's capacity to process conformity assessments for medical devices to ensure that safe and effective devices reach the UK public. DEKEA can now assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002 and will be able to issue relevant certification to allow manufacturers to place a UKCA marking on their products before putting them on the UK market.

Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health. Approved Bodies play a critical role in the supply of medical devices and expanding capacity is vital to the successful development of the UK’s medical device regulatory regime. This has been a significant piece of work and our teams have worked extremely hard to get to this stage."

ASA ruling provides further guidance on 'biodegradable' advertising claims

In a recent Advertising Standards Authority (ASA) ruling, it considered whether the following claims in relation to baby wipes marketed by Q River Ltd were misleading: "being 100% biodegradable* is really important to us as it means today’s sticky mess won’t be a problem for tomorrow’s generation. Our tests show that our wipes break down quickly after they are thrown away; in as little as 15 days; even in landfill conditions*”.

Green claims continue to be a hot topic. This ruling sheds light on how the ASA is likely to treat future claims around biodegradability. It also confirms the ASA's strict approach when assessing companies' attempts to substantiate their green claims.

The key takeaways from the Q River Ltd ruling are:

• Substantiation carried out in optimal (and unrealistic) conditions (such as milling down baby wipes, which is unlikely to happen in reality) to support biodegradable claims are likely to be deemed as misleading.
• Substantiation for biodegradable claims should also include tests that take into account any type of waste which is typically found on the product when it is disposed of;
• Any absolute claims relating to the environment (such as "good for the planet") require substantiation for the environmental impact of the product for its whole life cycle; and

• Products biodegrading in landfills are likely to release methane, which is a highly potent greenhouse gas and can contribute to global warming. As businesses are unlikely to have any control in capturing the gas, it appears unlikely that the overall life-cycle analysis of a biodegrading product (that emits methane in the process) will be deemed to have a positive impact on the environment.  

New guidance published ahead of Scotland's Deposit Return Scheme

Please see Environment.

Organisations can apply for grant to test security of smart devices

Please see Cyber Security.