Directives and regulations are legislative provisions. They define the obligations of those involved in the process of manufacturing and marketing machinery. However, they are not intended to specify technical aspects related to design compliance. Technical standards, on the other hand, are specifically designed to assist professionals in the design process.

Technical standards are documents issued by organisations governed by private law, whether national or supranational. They are not binding legislative provisions: their application is optional. Manufacturers are free to adopt any technical solutions they deem appropriate to meet the requirements of the Machinery Directive or Regulation. However, this freedom of choice can present challenges. For designers, it may be extremely difficult to develop a suitable technical solution without any reference parameters. Similarly, it may be very complex to objectively determine whether a chosen measure sufficiently reduces risk. Technical standards assist manufacturers by establishing a common reference standard, which may allow designers to either adopt a widely recognised safe solution or compare it with their own approach.

Harmonised standards belong to a special category of technical standards. They are issued by European standardisation bodies at the request of the European Commission and establish a uniform reference standard across the entire EU. Harmonising technical standards facilitates the free movement of goods within the EU. Although they are not legally binding, they can still be used as a reference in commercial transactions. EU member states are obliged to withdraw any conflicting national standards, ensuring no regulatory overlap between national and harmonised European standards.

Harmonised technical standards are particularly important in the machinery sector as they provide a presumption of conformity with the relevant essential health and safety requirements. A standard is considered harmonised when its reference is published in the Official Journal of the European Union. Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 delegate to harmonised standards the task of suggesting technical solutions, that, when applied, provide a presumption of conformity with the EHSR. By adopting the solutions recommended by harmonised technical standards, manufacturers are assured that the machinery complies with the applicable essential safety requirements, meaning that their machinery meets the Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 requirements for CE marking.

A non-harmonised technical standard does not guarantee a presumption of conformity with the EHSRs. Therefore, before adopting the requirements of any technical standard, manufacturers should check whether it is harmonised. The list of harmonised standards is updated approximately every six months and is accessible on the European Union’s website.

Manufacturers are not obliged to follow the requirements of the harmonised technical standards. However, they should be aware that authorities may request evidence of conformity of the technical solutions adopted at any time. In such cases, the assessment will likely be based on the common reference standard, which, for machinery, is defined by harmonised technical standards