AREA OF EXPERTISE

CE marking

Machines, plants and electrical devices

What is CE marking all about?

The CE marking (from the French Conformité Européenne) indicates that a product complies with the essential health, safety and environmental protection requirements of the relevant European directives and regulations.

It is mandatory for many products sold in the European Economic Area (EEA) – missing or incorrect CE markings can result in fines, sales bans or recalls!

Products subject to labelling requirements include, for example, machinery and equipment, electrical appliances (e.g. household appliances), pressure equipment, radio equipment, personal protective equipment, medical devices, etc.

Key facts about CE marking

Self-certification


The manufacturer usually declares on his own responsibility that his product complies with the relevant EU legislation. In certain cases, verification by a notified body (e.g. TÜV) is required.

No quality guarantee


The CE marking is not a label of quality – instead, it ‘only’ indicates compliance with minimum legal requirements, e.g. for health and safety.

Legal significance


Products without CE marking may not be sold in the EU or EEA if there is a corresponding obligation (e.g. for machinery, electrical equipment, toys, medical devices).

Documentation


Manufacturers must draw up a declaration of conformity and keep technical files at their disposal to demonstrate that the product complies with the requirements.

CE marking of machinery, plants and electrical equipment

Step by step to CE

Different European regulations apply depending on the product. Although the necessary steps in the ‘conformity assessment procedure’ are similar, they differ in details, as can be seen, for example, in the procedural steps for machines and electrical products:

CE according to Machinery Directive and Machinery Regulation

(Machinery, plants, lifting gear)

  1. Classification of the product as ‘machine’ or ‘incomplete machine’ in accordance with the Machinery Directive or Machinery Regulation
  2. Determination of other applicable CE directives and CE regulations for the machine
  3. Review of applicable harmonised standards
  4. Performance of risk assessment
  5. Preparation of the legally required technical files as evidence and supporting documents in the event of accidents or official complaints
  6. Involvement of notified bodies in special cases
  7. Internal production control to verify that the machine built complies with the technical files
  8. Preparation and signature of the declaration of conformity, affixing of the CE mark

Note: The requirements of the Machinery Directive and Machinery Regulation also apply to companies that manufacture machines for their own production (‘in-house production’)!

CE according to Low Voltage Directive 2014/35/EU

(electrical devices)

  1. Checking which EU directives and EU regulations apply to your product in addition to the Low Voltage Directive (e.g. EMC Directive, Radio Equipment Directive, etc.)
  2. Researching which harmonised European standards are applied voluntarily.
  3. Practical tip: Don't view standards as annoying regulations, but as a valuable source of knowledge!
  4. Performing and documenting risk assessment
  5. Compiling technical documentation as evidence and supporting documents in the event of accidents or official complaints
  6. Performing internal production control to verify that the manufactured electrical equipment complies with the technical files
  7. Preparing and signing the legally binding declaration of conformity, affixing the CE mark

With the declaration of conformity, the manufacturer declares that its products (e.g. machines, systems, electrical devices, etc.) meet the applicable safety and health requirements of the corresponding EU directives and regulations

The most important components of such an EC (according to the Machinery Directive) or EU declaration of conformity (according to the Machinery Regulation) are:

  1. Product identification
    • Product name, model number, type designation
    • Serial number (if applicable)
  2. Manufacturer's information
    • Name and full address of the manufacturer or its authorised representative in the EU
  3. Declaration of conformity
    • Declaration of the product's compliance with relevant EU harmonisation legislation
  4. List of EU directives and regulations applied
    • E.g.: Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU)
  5. List of applied harmonised standards or common specificationsn
    • Standards and other documents for conformity assessment
  6. Information on the conformity assessment procedure
    • Based on internal production control (Module A)
  7. If applicable, notified body
    • Name and number of the notified body in the conformity assessment process
  8. Signature and responsibility
    • Name, position and signature of the responsible person
    • Place and date of the declaration
  9. CE marking
    • Note regarding the affixing of the CE mark to the product

CE-Marking in Switzerland

The two questions most frequently asked by Swiss manufacturers concern the affixing of the CE mark and the geographical location of the persons referred to in the Machinery Directive.
 

CE-Mark

Manufacturers in Europe must affix a CE mark to the machine as proof of conformity. This requirement does not apply to machines manufactured in Switzerland that are not exported to the EU. This is also mentioned by SECO on its homepage:

The CE marking is generally not required in Switzerland. If the sector-specific legislation in Switzerland provides for a conformity marking, the CE marking can be attached as an alternative to the Swiss conformity marking.

This requirement can also be found in the new Swiss regulations. For example, the EMC Regulation (VEMV) in Art. 13, Paragraph 1 requires:

Each device must be labeled with the conformity mark according to Annex 1 number 1 or with the foreign conformity mark according to Annex 1 number 2.

So it also seems pragmatic for manufacturers in Switzerland to mark the conformity of the products with the relevant guidelines by a CE mark.

Person established within the Community

The Machinery Directive regulates in Annex II which information the manufacturer of a machine must provide in the declaration of conformity. Among other things, the directive requires that the following information must be included:

Name and address of the person authorised to compile the technical files; this person must be established in the Community;

Similarly, the Machinery Regulation requires that this person must be established in Switzerland.

This could lead to the assumption that Swiss manufacturers face a bureaucratic burden when exporting to the EU. However, the bilateral agreements between Switzerland and the EU (Mutual Recognition Agreement, MRA) stipulate that it is sufficient for this (legal or natural) person to be resident in Switzerland or the EU.

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