FAQ

A CE marking helps manufacturers to demonstrate that their product complies with the rules that apply within the European Economic Area (EEA, consisting of the EU countries and Switzerland, Liechtenstein, Norway and Iceland). CE stands for Conformité Européenne, or: in accordance with European regulations. The purpose of the CE marking is both to promote free trade within the member states and to ensure safety for consumers and the environment.

If you want to market a consumer product in the EU, this must in many cases be provided with a CE marking. You hereby indicate that your product meets legal requirements for, for example, safety, health and the environment. Compulsory CE marking applies to more than twenty product groups, including toys, electronic household appliances, construction products, gas appliances, measuring instruments, mobile phones and lifts.

As a manufacturer, you have to determine yourself whether your product must have a CE marking and whether your product meets the requirements. If this is the case, you must apply the marking yourself. In the case of a product from outside the EEA, the importer must check whether the product has a CE marking and whether it meets the requirements. When an importer places a product on the market under his own name he also takes over the responsibilities of the manufacturer, also when it comes to the CE marking. The manufacturer or importer is responsible for the product at all times.

Step 1 – Check which EU guidelines apply to your product:
There are EU directives for product groups for which CE marking is mandatory. For example the Low Voltage Directive (LVD), the Radio Equipment Directive (RED) and the Electromagnetic Compatibility (EMC) Directive. It is quite possible that several guidelines apply for one product group.

Step 2 – Check to which standards you need to test your product:
As a manufacturer you can use harmonized standards to test the safety of your product for each directive. For example, in the RED we know ETSI EN 300 328. This is a standard you can use to test ‘Data transmission equipment’ operating in the 2.4 GHz ISM band. It may be possible that no harmonized standard is available for your product. If this is the case, you can contact a Notified Body for the relevant guideline. Kiwa Telefication is a Notified Body for the RED.

Step 3 – Test your product and check whether it conforms to the guidelines:
The manufacturer or importer of a product must test the product and verify that it complies with the essential requirements of the applicable directives. An important part of this is risk assessment and testing against the applicable standards.

Step 4 – Prepare technical documentation and keep it available to market surveillance authorities on request:
Manufacturers must demonstrate their product meets relevant requirements by making technical documentation available. This documentation includes product designs, specifications, test reports, test certificates, a manual and a declaration of conformity. Importers of products that have been manufactured outside the EEU must have a written statement in which the manufacturer pledges that the documentation can be provided at the request of the market authority. The documentation must be kept for 10 years after the manufacturing date of the product;

Step 5 – Apply CE marking to your product and draw up an EU Declaration of Conformity:
The CE marking must be affixed in a visible, legible and indelible manner on the product or on its information label. If you made use of the services of a Notified Body as Kiwa Telefication during the product inspection, the identification number of this Notified Body must also be stated on the product. By drawing up and signing a declaration of conformity you indicate that you are responsible for the conformity of the product.

Source: website Netherlands Enterprise Agency

There are CE guidelines for numerous product groups, ranging from explosives and pyrotechnic articles to medical devices and toys. Kiwa Telefication is mainly specialized in testing and certifying electrical equipment. When it comes to CE marking, we distinguish six guidelines for this product group:

1. Electromagnetic compatibility (2014/30/EU);
2. Low voltage equipment (2014/35/EU);
3. Equipment and systems used in potentially explosive places (2014/34/EU);
4. Radio equipment (2014/53/EU);
5. Restrictions on the use of hazardous substances in electrical and electronic equipment (2011/65 / EU);
6. Ecodesign for energy-related products (2009/125/EC).

Kiwa Telefication has an accredited laboratory where experienced professionals can test your products for electromagnetic compatibility (EMC), electrical safety and the correct use of the radio spectrum (frequency range and immunity). High-quality test equipment is used for these tests, for example the CMW500 from Rhode & Schwarz.

If a product makes use of wireless connectivity it is considered a radio product. In other words, if a product deliberately transmits radio waves and/or receives radio waves for radio communication and/or radio determination. Examples of well-known radios are: WiFi, Bluetooth, Zigbee, Zigfox, Ant+, GPS, 4G and 5G. These radio techniques can be found in various products that can be operated wirelessly. Think of your phone, tablet, TV, smartwatch, router but also a refrigerator, baby monitor, air conditioning and the Internet of Things (IoT) market (devices that can be remotely operated and send remote notifications).

The Low Voltage Directive (2014/35/EU) applies to most electrical appliances we use in our daily lives. The directive stipulates that electrical equipment can only be placed on the market if it does not endanger the safety of persons, pets or other equipment and goods. The resulting electrical safety tests are mandatory for products with CE marking that fall within the scope of this directive.

The Low Voltage Directive (2014/35/EU) applies to products with an input or output voltage between 50V and 1500V. Products with an input or output voltage below are not covered by the low voltage directive. However, when the product deliberately transmits and/or receives radio waves for radio communication and/or radio determination, the Radio Equipment Directive (RED) applies. The RED states that products covered by this directive must be constructed in such a way that the safety of people, animals and goods is guaranteed, including the safety regulations of the low voltage directive, but without applying the voltage limit. Testing the electrical safety of radio products is therefore a requirement regardless of the power supply.

Yes, if you are developing a new product and you want to know whether you are on the right track when it comes to compliancy, you can contact Kiwa Telefication for an interim evaluation (pre-scan/ pre-compliance test).

Yes, you are more than welcome in our test lab. Our experts will gladly tell you more about the CE process and give you a tour of our lab. Naturally, we closely monitor the security and confidentiality of both your product and that of our other customers.

Kiwa Telefication specializes in testing and certifying radio products. We are a global provider of testing and certification in the field of radio, ITE, telecommunications, alarm and maritime equipment. In over two decades we have built up an exclusive position in the world market. Kiwa Telefication is located in Apeldoorn (the Netherlands), employs over thirty qualified experts and offers its services in a worldwide network, including from its own office in Taiwan. In addition to testing and certifications for Europe (RED), we offer services regarding FCC (USA), ISED (Canada) and MIC (Japan) certification. If you want to know more about certain certifications or certificates, please contact us.

By drawing up and signing a declaration of conformity you indicate that you are responsible for the conformity of the product. The drafting of a declaration of conformity is not a daily job for many manufacturers and importers. The experts of Kiwa Telefication can support you with this. Please contact us if you want us to support you in this process.

The CE marking guidelines require the manufacturer of a product to compile a technical file (technical construction file) that demonstrates that the product meets the requirements of the applicable guidelines. In general, a technical file must contain the following documents:

• Description of the device;
• Wiring and circuit diagrams;
• General overview design;
• List of applied standards;
• Registration of risk and standard assessments;
• Description of operating logic;
• Datasheets for essential subassemblies;
• Parts list;
• Copies of existing markings and labels;
• Copy of instructions (user, maintenance, installation);
• Test reports;
• Quality control and commissioning procedures;
• Declaration of Conformity.