When does My Product Need a CE Mark?

In short: yes, but!

The CE mark on a product indicates that the product complies with all applicable European Union directives and regulations. Knowing and complying with these rules is therefore the first priority, followed by affixing the CE mark.

Affixing a CE mark is only permitted if the product falls under an EU directive or regulation and if this directive or regulation does not stipulate otherwise.

Sources:

• „Blue Guide”
  • Chapter 4.5.1
  • Annex 5
  • Please note: The Blue Guide is a guide; in case of doubt, the text of the applicable EU laws always applies (see also “IMPORTANT NOTE” in the Blue Guide).

EU regulations apply to end products. In case of doubt, the relevant directive or regulation defines what constitutes an end product. If it does not contain any specific provisions, it applies to products within its scope, regardless of whether they are intended for further installation or not. Knowing the applicable directives and regulations is therefore the first step; only then can the next steps be determined.

The manufacturer or distributor is always responsible for the conformity of a complete product. In doing so, they can rely on any existing declarations of conformity or test reports for an integrated product. Even if your product does not have to or is not allowed to bear the CE mark, it is advantageous for your customers if you are familiar with the applicable rules (if necessary for potential complete products) and, as far as possible, provide documentation proving compliance.

Sources:

• „Blue Guide”
  • Chapter 2.1.
  • Please note: The Blue Guide is a guide; in case of doubt, the text of the applicable EU laws always applies (see also “IMPORTANT NOTE” in the Blue Guide).

EU regulations apply to end products. In case of doubt, the relevant directive or regulation defines what constitutes an end product. If the product is installed in a machine, the Machinery Directive may apply. Its scope also covers so-called “partly completed machinery,” which is defined in Article 3, paragraph 10.

However, if the product is, for example, an electronic control unit that falls under the Low Voltage Directive, the requirements of the Low Voltage Directive apply. It is therefore essential to know the applicable directives and regulations before determining the next steps.

The regulations for partly completed machinery are similar to those for machinery, but differ in the details. For example, Article 11 specifies the obligations of manufacturers of partly completed machinery and Article 22 specifies the requirements for the EU declaration of incorporation. With the EU declaration of incorporation, the manufacturer declares that the partly completed machinery meets all the requirements of the regulation.

Sources:

• „Blue Guide”
  • Chapter 2.1.
  • Please note: The Blue Guide is a guide; in case of doubt, the text of the applicable EU laws always applies (see also “IMPORTANT NOTE” in the Blue Guide).
• Machinery Directive
  • Article 2 (Scope) 1. and 2. p)
  • Article 3, paragraph 10
  • Article 11
  • Article 22, paragraph 4

Article 24 of the Ordinance on the Prevention of Accidents and Occupational Diseases lays down the principle for work equipment. These must “[...] not endanger the safety and health of employees” (paragraph 1), and paragraph 2 essentially refers to the legislation governing the placing on the market of the relevant products. Anyone who builds work equipment themselves therefore becomes its manufacturer, and essentially the same rules apply as if the work equipment were sold as a product.

The EKAS information sheet makes special mention of self-built machines. If the self-built work equipment is considered a machine, e.g. because it contains moving parts and a drive system, it must meet the requirements for placing on the market in accordance with the Swiss Machinery Ordinance. This includes, among other things, compliance with the essential safety requirements of the European Machinery Directive and the availability of technical documentation, operating instructions, and a declaration of conformity.

The Federal Coordination Commission for Occupational Safety (EKAS) has published a leaflet on self-built work equipment. This is part of the guidelines on occupational safety, which also contain the work equipment directive and a collection of other legal bases.

Incidentally, this article only deals with the placing on the market of self-built work equipment. One of many other aspects of occupational safety is the maintenance of work equipment, regardless of whether it is self-built or not.

Sources:

• Swiss Ordinance on the Prevention of Accidents and Occupational Diseases, Article 24
• EKAS guidelines
• Information sheet on self-built work equipment
• European Machinery Directive
• Swiss Machinery Ordinance, Article 2 b.
• European Machinery Directive, Article 5, Annex I, Annex VII

Yes, if the desired function can be implemented with one or more commercially available products.

However, it must be checked whether this combination of products can be regarded as an end product, which in turn must comply with the applicable directives and regulations. If the components are CE marked, this does not automatically guarantee that their combination also complies with the applicable regulations. This is the case, for example, when CE-marked components are assembled in a control cabinet to form a new product.

Sources:

• „Blue Guide”
  • Chapter 2.1, keywords ‘combination’
  • Please note: The Blue Guide is a guide; in case of doubt, the text of the applicable EU laws always applies (see also “IMPORTANT NOTE” in the Blue Guide).