Updating the EU’s product liability and safety regimes is a process which has been underway for a significant time.  To put this in context, these regimes had been governed by a directive enacted in 1985 (product liability) and a directive from 2001, replacing an earlier directive from 1992 (product safety). These directives were both transposed into Irish law by various pieces of domestic legislation. It was clear that the products framework needed to be modernised to align with the digital age as well as with the increasing amount of goods and products which are sold online. December 2024 therefore saw the beginning of what is undeniably a new era, with two key pieces of legislation formally coming into operation:

• The new Product Liability Directive (the “New Directive”) came into force on 8 December 2024 and Member States must transpose the New Directive into national law by 9 December 2026.
• The new General Product Safety Regulation (“the GPSR”) became operational on 13 December 2024 – it is in effect as of that date. The GPSR also applies to placing goods on the market in Northern Ireland.

Member States to transpose new Product Liability Directive by December 2026

The New Directive repeals and replaces its 1985 predecessor. However, the previous regime will continue to apply to products placed on the market or put into service before 9 December 2026. The New Directive has brought in some major changes. Some key reforms are below:

• The definition of “product” has been expanded to include electricity, digital manufacturing files, raw materials, and software (including AI systems). While the New Directive does not define “software”, certain forms are outlined in the Recitals, including AI systems. It also covers products integrated into or interconnected with other products. However, it excludes free and open-source software developed or supplied outside commercial activity. New provisions address liability for digital services that affect product functionality.
• There is a new concept of “economic operator” which means a manufacturer of a product or component, a provider of a related service, an authorised representative, an importer, a fulfilment service provider, or a distributor. Where an economic operator established in the EU cannot be identified, each distributor of the defective product is liable if the distributor fails to identify an economic operator established in the EU or its own distributor upon request. This also applies to any provider of an online platform that allows consumers to conclude distance contracts with traders and that is not an economic operator.
• The concept of injury now includes “medically recognised damage to physiological health” as well as “destruction or corruption of data not used for professional purposes.”
• The ten year long-stop period from placing on the market, following which a person is no longer entitled to seek compensation, remains. However, a new concept of latency has been introduced, whereby if a person has not been able to initiate proceedings due to latency of a personal injury, their ability to claim compensation shall expire after 25 years.
• Member States can choose to introduce the so-called “development risks defence” and must notify the European Commission of their intention on this point no later than 9 December 2026. This defence provides that the objective state of scientific and technical knowledge at the time the product was placed on the market/put into service/within the manufacturer’s control was not such that the defectiveness could be discovered. Ireland and many other Member States had incorporated this defence into national law under the previous product liability regime. Several other defences are also available.
• A claimant is still required to prove the defectiveness of a product, the damage suffered and the causal link between the defect and the damage. However, there is a presumption of defectiveness or no-fault liability which can apply if certain criteria can be met – which it is then for the defendant to attempt to rebut. The New Directive introduces no fault-based liability for producers and presumes defectiveness where (a) the defendant fails to disclose “relevant evidence,” (b) the claimant demonstrates that the product does not comply with mandatory safety laws, or (c) the claimant demonstrates that the damage was caused by an obvious malfunction of the product. There is an onus on Member States to make provision for the disclosure of evidence piece set out in detail in Article 9.

There are some potential challenges for economic operators posed by the New Directive and those involved at all stages of the supply chain will need to be compliant with the new regime, in order to minimise risks.

GPSR – applies as of 13 December 2024

In a separate but related development, the GPSR applies to products placed on the market as of 13 December 2024. It is important to note that this piece of legislation applies directly, given its status as a regulation and that it also applies to Northern Ireland. The UK government has provided guidance on the Northern Ireland market. The European Commission dedicated website also has links to various pieces of useful information, with a set of guidelines for business awaited. Again, some key changes are below:

• The GPSR applies to most consumer goods but there are some exceptions: medicinal products for human or veterinary use, as well as food and feed, are outside scope.

• For some other categories of product, the GPSR imposes new obligations only where sector specific legislation has no equivalent measures. Some parts of the GPSR apply to all products, regardless of whether there is sector specific legislation, such as the obligations for providers of online marketplaces. In short, careful analysis will be needed as to the various parameters at play.

• “Product” means any item, whether or not it is interconnected to other items, supplied or made available, whether for consideration or not, including in the context of providing a service, which is intended for consumers or is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them.

• The GPSR imposes specific obligations on those with various roles in the supply chain:  collectively, “economic operators” but each with distinct roles. These include the manufacturer, authorised representative, importer, distributor, and fulfilment service provider. There are a host of obligations on providers of an online marketplace.

• A product shall not be placed on the market unless there is a responsible person i.e. an economic operator established in the EU.

• There are provisions made for the provision of information as between Member States by means of a Safety Gate Rapid Alert System and for manufacturers to notify through a Safety Business Gateway. The manufacturer must notify of an accident without “undue delay” with similar obligations on importers and distributors in terms of notifying a manufacturer.

Looking ahead

On the product liability side, we can expect a consultation on the transposition of the New Directive into Irish law, with draft legislation to follow which will need to be enacted by the Oireachtas. In relation to product safety, it remains to be seen how Ireland will enforce breaches of the GPSR, with some clarity on this awaited.

It will also be interesting to see how the proposal for an Artificial Intelligence Liability Directive, which was published in 2022 at the same time as the proposal for the New Directive, moves through the legislative passage at an EU level and if ultimately enacted, where this sits alongside the GPSR and the New Directive in the product compliance landscape. Progress on this had been on hold until the EU’s Artificial Intelligent Act  had been finalised.

The rule book has been completely rewritten, and compliance is key. Potential criminal sanctions, reputational damage and litigation risk are just some of the ramifications that might be avoided, if proper steps are taken to get to grips with these new laws. It is also worth noting that both breaches of product liability and product safety legislation are specifically envisaged as being caught by the Representative Actions Directive, which has been transposed into Irish law by the Representative Actions Act 2023.

If you would like to discuss any of the matters covered in this briefing, please get in touch with any member of our Product Liability Disputes Group or Life Sciences Group.