Laws and standards in Europe

Within the European Union, there are numerous directives and regulations that set out the legal framework for products and how they are placed on the market. While directives must be transposed into national law by each individual member state, regulations apply immediately in all EU member states.

A common feature of many of these regulations is that products falling within their scope are subject to a CE marking requirement.

In non-EU countries, different statutory regulations and standards may apply in some cases, and these must also be taken into account.

In the European Union, directives, regulations, national laws and standards form the basis for the regulation of products and their safety. EU directives and EU regulations set out the legally binding requirements that manufacturers must meet to enable them to place their products on the European single market.

European standards (EN standards) play a key role in the practical implementation of these requirements. Although in principle standards are not legally binding, they do describe the current state of the art and science. They provide manufacturers with specific technical solutions to ensure compliance with legal requirements.

As soon as standards are published in the Official Journal of the European Union, they are regarded as harmonised standards. When they are applied as part of an EU conformity assessment procedure, they lead to "presumption of conformity". This means that manufacturers can assume that their product meets the essential health and safety requirements of the respective EU directive or EU regulation.

Another advantage for businesses: when directives, regulations and harmonised standards are applied correctly, then the burden of proof may be reversed in the context of product liability. In the event of an incident, the relevant market surveillance authorities or the public prosecutor’s office must then prove that the legal requirements were not met.

Machinery Directive

When the Machinery Directive (MD) was ratified in 1993, the aim was to remove trade barriers and enable a free internal market within Europe. After a two-year transition period, the Machinery Directive has been binding in Europe since 01.01.1995. It describes standardised health and safety requirements for interaction between human and machine and replaces the host of individual state regulations that existed on machinery safety. The Machinery Directive 2006/42/EC has applied since 29.12.2009. It will be replaced by the Machinery Regulation (EU) 2023/1230, with the key date of 20 January 2027.

EU Machinery Regulation (EU) 2023/1230

The Machinery Regulation will replace the existing Machinery Directive from 20 January 2027 and sets out the essential health and safety requirements for machinery and related products within the European Union. It is effective immediately and must be applied in all member states. The aim is to guarantee a high level of machinery safety while at the same time promoting the free movement of goods within the single market.

The Regulation takes particular account of new technological developments such as digitisation, artificial intelligence, networked systems and specifically Industrial Security. It sets out clear requirements for the design, manufacture, conformity assessment and CE marking of machinery. In addition, the obligations of manufacturers, importers and operators are clarified in order to minimise risks at an early stage and guarantee product safety throughout the entire lifecycle.

Find out more about the Machinery Regulation

Cyber Resilience Act

In addition to the EU Machinery Regulation, the Cyber Resilience Act (CRA) is also an EU regulation that will introduce new legal requirements regarding the cybersecurity of products containing digital elements. The aim is to enhance the security of hardware and software products throughout their entire lifecycle and to systematically reduce vulnerabilities. Manufacturers will be obliged to take security requirements into account right from the development phase ("Security by Design") and to guarantee regular updates and effective vulnerability management. At the same time, the CRA enhances transparency for users and helps to increase trust in digital products within the European single market.

Find out more about the Cyber Resilience Act

Mandatory CE marking

There is mandatory CE marking for products that fall under the scope of one or more of the directives and regulations below. These products must also be accompanied by a declaration of conformity.

With a declaration of conformity, which is legally binding, manufacturers confirm that their product meets all the requirements of the European directives relating to their product. This means they can launch and sell their product within the scope of the EU, currently 27 EU states as well as Switzerland, Norway and Turkey, without consideration of any national provisions.

Declarations of conformity for Pilz products are available in our download area.

Examples of EU directives/regulations requiring CE marking

• Machinery Regulation (EU) 2023/1230
• Explosion Protective Directive 2014/34/EU
• Pressure Equipment Directive 2014/68/EU
• EMC Directive 2014/30/EU
• Low Voltage Directive 2014/35/EU

Great Britain left the EU on 31.12.2020. Britain’s exit from the European Union has significant effects for plant and machine manufacturers. We’ll explain what these are:

Further information

However, existing regulations will remain in force!

A specific work equipment directive applies in Great Britain: Provision and Use of Work Equipment Regulations (PUWER).

These regulations cover all work equipment used by staff in the course of their work - from a hammer to mechanical presses and motor vehicles. The "use" of work equipment also covers maintenance, cleaning, transportation or commissioning of the work equipment.

PUWER not only requires appropriate work equipment to be provided and correctly maintained, but also that risks resulting from use of the work equipment must be prevented in advance.

Download the PUWER regulations