Topic outline



    Conformity assessment

    The EU aims to guarantee the free movement of products by harmonising requirements for products. The product requirements have been harmonised by directives, regulations and decisions. Every member state of the European Union is obliged to introduce the directives into the country’s legislation through national laws and regulations. On the other hand, regulations and decisions are directly applicable and shall enter into force as such in the member states.

    The laws, directives, regulations and decisions set forth the fundamental requirements for safety, environmental considerations, consumer protection, and energy efficiency related to electrical equipment, along with the applicable conformity assessment procedures. Equipment may be placed on the EU market and brought into use only if it meets the essential requirements set forth in the applicable directives.

    The manufacturer is responsible for ensuring that the electrical equipment meets all the applicable requirements. The manufacturer must carry out the applicable conformity assessment procedure or have it carried out; this comprises the evaluation and testing that allow the conformity of the equipment to be assessed and verified. The technical requirements and test methods for the electrical equipment are set out in the relevant standards. If the design, manufacture, inspection, and testing of the electrical equipment are carried out in compliance with harmonised standards and the equipment fully meets the requirements of these standards, the equipment is presumed to be in conformity with the applicable essential requirements (presumption of conformity). However, the application of harmonised standards is voluntary. The manufacturer may, alternatively, choose some other way of attesting conformity with the essential requirements of the Directives. In practice, however, this approach is more difficult than following the established standards.

    The regulations specify whether a notified body is required to be involved in the conformity assessment of the electrical equipment. A notified body is an instance notified to the European Commission by a member state that is authorised to carry out conformity assessment tasks; these are listed in the NANDO database. Market surveillance authorities do not inspect equipment before they have been placed on the market.

    Once the manufacturer of the electrical equipment has drawn up the technical documentation and demonstrated the equipment’s compliance with the applicable requirements in accordance with the conformity assessment procedure, the manufacturer shall draw up and sign an EU declaration of conformity. To attest and prove conformity, the manufacturer must affix the CE marking to every piece of equipment placed on the market. In addition to the CE marking, the electrical equipment must include other required markings such as traceability information. The instructions and information necessary for the safe and purposeful installation, operation, maintenance, and decommissioning of the equipment must also be delivered with the equipment, in Finnish and Swedish.

    In the serial production of electrical equipment, procedures must be in place to ensure that all equipment meet the essential requirements of the regulations. Changes to the equipment's design or features, along with changes to harmonised standards or technical specifications on the basis of which the conformity of the equipment is declared, must be taken into consideration in the conformity assessment of the equipment.

    Technical documentation

    It is the manufacturer’s responsibility to prepare technical documentation concerning the electrical equipment in accordance with the conformity assessment methods. As a general rule, the documentation must contain at least a description of the equipment and its intended use and include information on the design, manufacture and operation of the equipment. The documentation should include information that demonstrates the conformity of the equipment and the risk assessment carried out by the manufacturer. Furthermore, if a harmonised standard for conformity assessment is only partly applied or does not cover all the essential applicable requirements, the technical documentation should also include how these essential requirements not covered by the standards are addressed.

    The technical documents do not need to be translated into the language of the member state, but they must be in one of the languages of the Union. Some conformity assessment methods require that a notified body participates in the assessment of the equipment. In this case, the documents must be in the language used by the notified body.

    In the event that the design of the electrical equipment is changed, or its conformity is reassessed, the technical documentation should take into account all versions of the equipment. In such cases, the documentation should describe the changes made, and how the different versions of the equipment can be identified, and it must provide information on the different conformity assessments.

    The technical documentation must be kept for 10 years from the date on which the electrical equipment was placed on the market. This is the responsibility of the manufacturer or its authorised representative established within the EU. Since the concept of placing on the market refers to a single equipment, the deadline must be calculated from the moment when the “last” single equipment covered by the technical documentation was placed on the market.

    Product certification and certification labels in Europe

    Product certification takes the conformity assessment of the product to the next level. While the CE marking is based on the manufacturer’s own conformity assessment, in product certification, an accredited third party performs a type test of the product in its testing laboratory and issues its own certification mark to be affixed to the product. The certification mark on the product tells the user quickly that the product has been tested and certified by a third party. Product certification typically concerns electrical safety, but some product certification marks require that other requirements are also tested on the product, such as EMC or chemical and hazardous substances in the product.

    It is also possible to verify the authenticity of the certification mark from the certification database of the third-party that has issued the certificate, where the name and model of the product should produce results proving that the product has been certifiedthe. It is also important to check according to which standard the product has been certified.

    Typical product certification marks in Europe:

    Typical product certification labels in Europe

    Product certifications are national certification marks, but they are often based on an EN standard in Europe and thus also on an IEC standard. The ENEC certification mark is pan-European, and the number after the mark indicates the country of the business that issued the certificate.

    When assessing conformity, the certification mark on the product that can be verified from the database of the issuing party is a strong signal of conformity. However, the standard used for certification should also be checked to ensure that it concerns electrical safety. 

    In addition, product certification involves feedback, as the third party issuing the certificate will carry out at least one inspection per year to ensure that the product still conforms to the type-tested structure. The audit typically examines safety-critical components, their certification and dimensioning, product markings and production testing (e.g. electric strength, continuity of grounding and measurement of insulation resistance). In addition, the ISO 9001 quality management certification is often required from the manufacturer.

    You can search for certifications such as the above examples at:

    Product certification (and the testing it requires) can be used to lighten the type testing of the  end product. Typically, the product has many safety critical components that should be tested separately according to the component standard (for example, the Y capacitor connected between the primary and secondary in accordance with its own EN 60348-14 standard). For example, if the Y capacitor has been tested and certified by an accredited third party, the Y capacitor can only be tested as part of the product, and no separate EN 60348-14 testing is required.  Critical components include components that bridge basic, double or reinforced insulation (X and Y capacitors, transformers, optocouplers), insulation and its materials, enclosure materials, connectors, cables and fuses.   

    Counterfeits of the product certification marks are also in circulation, so it is good to check the authenticity and validity of the mark on the product in the database of the third party that issued the certification. The use of product certification is not mandatory in the European Economic Area.


    International product certification (IECEE CB Scheme) 

    Outside Europe, different countries may have requirements for mandatory national product certification (UL, CSA, CCC, etc.) or other national approval procedures to allow the electrical equipment to circulate freely in the country (EAC, RCM, KC, etc.). One starting point is to test the product in accordance with international IEC standards, taking the national modifications to the IEC standard announced by the target country into account. Here, the IECEE CB Scheme provides a good starting point for the manufacturer.

    You typically come across the IECEE CB Scheme and CB certification when exploring alternatives to international product certification. The CB Scheme is a programme operated by the IECEE and is based on the mutual recognition of test reports and certificates by the CB Scheme Certification Bodies and the Certification Body Test Laboratories (CBTL) under them. 

    IECEE CB Scheme logo

    A test laboratory within the CB Scheme performs the test in accordance with the relevant IEC standard for the product and prepares a test report on the official CB test report template. The national modifications to IEC standards (e.g. national changes resulting from EN standards) reported by different countries are also considered in the testing. Based on the CB test report, the certification body issues a CB certificate for the product, which also indicates which modifications to the IEC standard notified by the countries have been considered in the testing.

    In an ideal situation, the CB certificate can be used to apply for national certifications in different countries and the right to use a certification label without the need for further testing. Sometimes additional requirements may arise in different countries, but CB certification and the CB test report can be considered a good starting point for negotiations. As with national certifications, the authenticity of the CB certificate can be checked in the CB certificate database:


    Read more about the conformity assessment and technical documentation of electrical appliances:

    Conformity of products on the Tukes website

    The EU’s NANDO database (in English)

    I Know My Product webinar: Technical documentation