Digital or printed? Navigating liability and evidence in product instruction and safety information

I.    Introduction 

Manufacturers of consumer-facing products in the increasingly integrated European market operate in a complex regulatory and commercial environment. Under EU law, not only the product itself has to meet quality standards, but also the way it is presented to the consumer. As a result, clients often ask us:

• What product-related information must be provided (‘what’), and
• how must this information be provided (‘how’)?

While the ‘what’ refers to the content and level of detail required, the ‘how’ refers to the medium by which the information is provided to the consumer. Novel products are often integrated in digital ecosystems – so do they still need to be shipped with heavy print-outs? As products differ in terms of use, application, complexity or potential hazards to users and the environment, the regulatory requirements – and our clients’ responses – depend on the product itself, as well as the target group and market in which the product will be placed. However, the following aspects have proven to be common denominators applicable to most products:

II.    What and in which level of detail should information be provided?

When clients consider supplementing their product with information, they typically refer to instructions or user manuals and safety information. In general, a product may be deemed defective if no or insufficient user information is accompanying the product.

Besides various specific pieces of legislation that may apply to the product depending on its precise specifications and intended use, most consumer products must comply with both product liability and product safety laws, which are largely harmonised across the EU. 

As summarised in the European Commission’s 2022 Blue Guide on product information, consumer facing products must be accompanied by instructions for use and safety information. These must be clear, understandable, available at the time the product is launched on the market and include all necessary information for safe use (e.g. assembly, operation, storage and disposal information). 

It is up to each manufacturer to determine the adequate level of detail. The Commission requires them to ‘look beyond what they consider the intended use of a product and place themselves in the position of the average user […] and envisage in what way they would reasonably consider to use the product.’ Unsurprisingly, manufacturers tend to include more warnings than necessary (‘overwarning’), a practice that carries the risk of diluting information. 

III.    How should manufacturers provide instructions to consumers?

The choice of the medium used to convey product-related information depends on a variety of factors. Beyond complying with regulatory requirements, it is also worth considering potential liability and preserving evidence to mitigate litigation risk at the outset.

1.    The regulatory environment 

Currently, neither product safety nor product liability legislation defines the term ‘accompanying’ the product. New pieces of EU legislation currently in the pipeline are unlikely to provide clarity for manufactures. These legislative initiatives are:

• The Product Safety Regulation (Regulation (EU) 2023/988), replacing Directive 2001/95/EC on general product safety with entry into force in June 2023, applicable from 13 December 2024, and 
• The proposal of a new Product Liability Directive (ongoing Procedure 2022/0302/COD, latest draft: EP position at first reading), which is expected to be implemented into the Member States’ national law by 2026. 

Art. 9 (7) of the Product Safety Regulation requires manufacturers to ensure that their product is accompanied by clear instructions and safety information without specifying the format of this accompaniment. However, Art. 21 in conjunction with recital 32 of the Product Safety Regulation stipulates that information may additionally be made available in a digital format such through a QR or data matrix code, suggesting that safety information and instructions for use must in any case be provided in non-digital, i.e. paper, form. This may lead to additional requirements extending beyond those manufacturers currently have to adhere to:

As of now, the Commission interprets the general product legislation as only requiring safety information to be provided on paper. Other instruction may be shared digitally, through other data storage formats or on websites. This corresponds with the understanding of Member States’ courts (note that the ECJ has not yet opined on this): German courts have interpreted the term ‘accompanying’ as allowing manufacturers to provide information electronically. Similarly, in certain scenarios even the EU seems to be moving further away from the need for physical information. The European Medicines Agency has started a pilot project which aims to make the package leaflets for medical products digitally accessible. It remains to be seen whether this is the beginning of a new trend.

Either way, when deciding on a specific format for instructions and safety information, the above mentioned Commission’s guidance requires the manufacturer to ‘take account of the intended use of the product and its end users’. Where, e.g., a website is used to provide instructions, it must remain accessible for a reasonable period after the product was placed on the market, and a paper version should always be available free of charge for those consumers who request it (Blue Guide, Section 3.1).

2.    Mitigating litigation risk in Germany

Aside from regulatory requirements, it is also worth considering the potential civil liability and evidential perspective, from which having a paper element is advisable. As mass litigation and collective actions in Germany are evolving rapidly, litigation risk has become a significant aspect to consider when placing consumer-facing products on the market – both in terms of financial exposure and potentially negative publicity.

With regard to the medium used for providing information, potential litigants need to consider the burden of proof and possible modifications thereof, including presumptions of fact. Under the current German product liability law, the claimant bears the burden of proving the elements of a claim against the manufacturer. While the EU’s new Product Liability Directive does not change this in principle, it introduces several presumptions that effectively shift the burden of proof to manufacturers who have to demonstrate and prove that their product was not defective and/or that it did not cause harm to the claimant (for more detail, see our recent blog post here). Manufacturers should thus consider how they preserve product-safety related information for the purpose of defending future product safety and liability claims.

Claims for damages based on incorrect or insufficient user instructions for consumer products are particularly difficult to assess, as courts have to decide on a case-by-case basis whether the instruction has caused the damage and correct instructions would have prevented the damage. The German Federal Court of Justice requires ‘certainty’ in this regard. It did not, however, further define this criterion – thus leaving it to the discretion of the individual judge, who will likely take into account aspects such as the product’s complexity or potential hazards associated with its use.

If a manufacturer needed to rely on relevant warnings or disclaimers to defend a consumer claim, a consumer-friendly court may be more likely to conclude that a consumer should be treated as having seen a relevant disclaimer (to their potential detriment) if it can be shown that they were provided with such information in hard copy form at the time of purchase (versus a statement that they were able to obtain it online if they chose to do so). There may also be related considerations in respect of, e.g., vulnerable consumers or less tech savvy consumers. For product liability purposes, the product information supplied with a product is a specific factor to be taken into account by courts when assessing whether a product demonstrated the safety that a consumer is entitled to expect, and such information can qualify that expectation in certain circumstances.

In cases where a consumer alleges not to have received any user instructions at all, a paper version thereof (possibly in addition to an electronic version sent to the consumer, requesting a read receipt) may provide for sufficient proof where information displayed on a website does not. While a digital version provides flexibility and can be updated on a regular basis, it introduces uncertainty as to which and when specific information has been shared with the consumer.