Standards, Conformity and the State of the Art

1. Standards – Documentation of the State of the Art

It is the manufacturer’s responsibility to determine the design and engineering measures necessary to ensure product compliance. Risk-related legal design requirements, however, are typically formulated as objectives or goals. They therefore neither prescribe specific technical solutions nor provide detailed instructions on how compliance is to be achieved.

To meet these legal requirements, the measures adopted must correspond to the state of the art; this represents the benchmark level required for compliance. Beyond this general obligation, the legislation usually does not provide further technical detail.

This is where standards assume a key role. Their primary purpose is to specify and document the state of the art in a structured and transparent manner (see section 4 below).

2. Standards – Application of Harmonised Standards Published in the Official Journal of the European Union

Harmonised standards confer a presumption of conformity with the essential requirements they aim to cover, provided that their references have been published in the Official Journal of the European Union. Compliance with such standards gives rise to a legal - albeit rebuttable - presumption that the relevant essential requirements are fulfilled.

Accordingly, the manufacturer must demonstrate that the product has been designed and manufactured in accordance with the harmonised standard. The manufacturer is not required to prove the presumed fact itself, namely that compliance with the standard ensures fulfilment of the essential requirements covered by it.

The presumption of conformity applies only to those essential requirements that the harmonised standard (or specific parts thereof) is intended to address. These are usually identified in the informative Annexes ZA, ZB or ZZ of the standard. In some cases, the scope of the standard itself indicates the covered requirements with sufficient clarity, for example where specific safety-related risks are expressly referenced.

Thus, the information provided in a harmonised standard regarding the “aimed coverage of essential or other requirements” defines the limits of the presumption of conformity. In risk-related legislation, harmonised standards typically identify the significant hazards generally associated with a particular product category or safety aspect. Nevertheless, manufacturers remain fully responsible for verifying whether all relevant hazards identified in their risk assessment are covered by the applied standard and, where necessary, for selecting additional standards or other appropriate technical specifications.

3. Standards – Other Means of Demonstrating Conformity with Essential Requirements

Situations may arise where:

• no harmonised standard is applicable to the product;

• applicable harmonised standards are only partially applied; or

• harmonised standards do not address all relevant hazards.

  
  

In such cases, the manufacturer must demonstrate conformity with the essential requirements by other means of their own choosing, provided that these ensure the level of safety or protection required by the applicable legislation. Such means may include, for example:

• national, European or international standards that are not harmonised,

• other technical specifications or industry agreements,

• voluntary certification schemes or comparable third-party conformity-assessment frameworks,

• opinions of recognised scientific bodies or expert committees,

• established codes of good engineering practice within the relevant sector,

• the manufacturer’s own technical specifications.

In these circumstances, the manufacturer does not benefit from a presumption of conformity and must substantiate compliance independently. This generally entails providing a more detailed explanation in the technical documentation of how the applied technical solutions ensure fulfilment of the essential requirements.

4. State of the art

4.1. State of the Art – Required Level of Protection for Compliance with Risk-related Legal Design Requirements

As stated at the beginning, the wording of both European and national risk-related product legislation is typically formulated in general and broad terms. These provisions usually define the objectives to be achieved but refrain from prescribing detailed technical solutions or explicitly determining the level of protection required. This approach is particularly evident in the field of product safety, where mandatory requirements are intentionally technology-neutral so as to cover a wide range of potential risks and hazards.

At first glance, such general obligations might suggest that risk reduction efforts are unlimited. For example, Annex I (2)(b) of the Low Voltage Directive 2014/35/EU requires that technical measures ensure that “temperatures, arcs or radiation which would cause a danger are not produced.” A purely literal interpretation could imply that any injury—such as a burn from a hot surface—automatically demonstrates non-compliance. In practice, however, this conclusion would be incorrect.

Even where legislation is framed as an obligation to achieve a certain result, failure to eliminate every instance of harm does not necessarily indicate an inadequate or non-compliant design. Absolute protection cannot be achieved in real-world conditions: a zero level of risk does not exist, and neither regulators nor standardization bodies expect it. Instead, risk-reduction measures must be proportionate to the hazard, the available technology, and the economic context of the product category.

This principle is generally recognized: even where appropriate protective measures are implemented, residual risks may remain, since risk-related objectives cannot in every case be achieved completely when taking into account the state of the art. Accordingly, protection is understood not as the total absence of all risk, but as freedom from risks that are considered unacceptable in light of prevailing societal values.

Consequently, compliance with risk-related legal design requirements is assessed against the state of technical knowledge at the time the product is placed on the market. A requirement is deemed fulfilled if the adopted measures correspond to the technical know-how available at that time, as explained in the Blue Guide on the implementation of EU product rules 2022, section 4.1.1.

4.2. State of the Art – Concept and Definition

Although not formally defined in legislation, the concept of the “state of the art” is clarified in interpretative guidance to the Machinery Directive 2006/42/EC (Guide to application of the Machinery Directive 2006/42/EC, § 161). The term encompasses both technical feasibility and economic reasonableness.

To correspond to the state of the art, the solutions adopted must:

• Use the most effective technical means available at the relevant time;

• Be generally accessible on the market (i.e., not limited to experimental or research-stage technologies);

• Be implementable at a cost that is reasonable in relation to:

• the total cost of the machinery category, and

• the severity of the harm to be prevented.

This introduces a proportionality principle: higher risks - especially those involving severe or fatal injury - justify significantly greater expenditure and technical effort than risks associated with minor, reversible harm.

Manufacturers are not expected to apply technologies that are still under development or not widely available. However, they are required to take account of technological progress and adopt improved solutions once they become available at a reasonable cost.

The state of the art is therefore a dynamic concept. What is considered adequate at one point in time may become insufficient as technology advances or becomes more economically accessible. Manufacturers producing a series of products based on the same design must, within a reasonable transition period, adapt their designs to reflect such developments.

4.3. State of the Art – Expression Through Standards and Protection Levels

In practice, the state of the art is most clearly reflected in safety standards, including:

• Type A (basic safety standards),

• Type B (group or generic safety standards), and

• Type C (product-specific standards).

These standards describe the expected level of protection using various technical approaches, such as:

• Specific design solutions or protective concepts,

• System architectures,

• Development and validation methodologies (e.g., performance-based safety design),

• Dimensional requirements (such as safety distances or creepage distances),

• Limit values, performance thresholds, or test criteria.

Importantly, legal compliance does not necessarily require strict adherence to every technical specification contained in a standard. What is decisive is that the product achieves a level of protection equivalent to that reflected by the standard - that is, the protection level representing the state of the art.

Legislative references to the state of the art should therefore not be misunderstood as mandating a particular design or technical solution. Standards provide a benchmark, not an exclusive pathway to compliance. If, for example, a standard achieves a protection level that can be conceptually described as 80 on a scale of 100, any alternative solution achieving an equivalent or higher level of protection may also satisfy legal requirements, even if it diverges technically from the standard.

Summary:

The “state of the art” functions as the central interpretative benchmark linking broadly worded legal risk-related obligations with practical engineering solutions. It establishes a dynamic, technology- and risk-based standard of reasonableness rather than an unattainable expectation of absolute safety, ensuring both effective protection and proportionality in product design. Standards play a central role in this framework because they specify, structure and document the state of the art in concrete technical terms. Harmonised standards therefore provide manufacturers with a recognised benchmark for demonstrating that the adopted technical measures correspond to the required level of protection, while alternative solutions remain permissible where they achieve an equivalent level of safety.