RED guideline and certification

The RED (Radio Equipment Directive) is a European Union directive that has been in force since June 13, 2017, replacing the former R&TTE (Radio and Telecommunications Terminal Equipment) Directive. The RED regulates the requirements for radio equipment and telecommunications terminal equipment placed on the market in the EU. It takes into account not only electromagnetic properties and electrical safety, but also the health and welfare of animals and humans, as well as environmental protection. Companies wishing to sell their products in the EU must ensure that they comply with the requirements of the RED and must demonstrate this compliance through certification.

Which products are affected by the RED labeling requirement?

The RED directive applies to a wide range of products that use radio interfaces. Not only products that are explicitly intended for use in wireless networks are affected, but also those that merely have a wireless interface that is not necessarily intended for wireless operation. For example, even simple smart home devices such as lamps, power sockets or thermostats may be affected by the RED directive if they communicate via a wireless connection. The RED directive applies mandatorily to all products that fall within the scope of the directive. Products subject to the RED certification requirement include cell phones, tablets, WLAN routers, Bluetooth headsets, toys with a wireless connection or even medical devices with a wireless connection.

RED marking: cost, duration and validity

• What does RED certification cost?
  The cost of certifying and marking a product with the RED mark depends on various factors, such as the type of product, the complexity of the tests and the number of certifications required. As a rule, manufacturers must expect costs in the range of several thousand euros per product.

• How long does it take to obtain RED certification?
  The duration of the certification process also depends on several factors, including the complexity of the product and the testing required. Typically, the process can take anywhere from several months to a year or more.

• How long is the RED label valid?
  The RED marking remains valid as long as the product remains unchanged and complies with the applicable technical standards. However, if there are changes to the product that may affect compliance, retesting and possible updating of the certification must be performed.

RED certification is an extensive process that requires careful planning and implementation. Here, all the necessary documents must be obtained and checked to ensure that the products comply with the legal requirements. The Regul.ai software offers enormous relief here by providing all the necessary documents in the RED Collection and processing them with artificial intelligence to quickly and easily identify which requirements must be observed during the product launch. Regul.ai makes the certification process faster and more efficient, so that products can be launched on the German market more quickly.

What is the certification process for RED certifications and what steps are necessary to obtain a successful certification?

The certification process for RED certifications consists of several steps, which are usually carried out by a so-called "notified body". First, the product's technical documentation must be prepared and submitted, containing all relevant information about the product and its conformity with the RED requirements. Then, the product is tested in an accredited laboratory to ensure that it meets the requirements. When all tests have been passed and the documentation is complete, the certificate is issued and the product can be marked with the RED mark. It is important to note that this process may vary depending on the product type and complexity.

Are there marking and labeling requirements of RED to product and packaging

Yes, there are marking and labeling requirements for products that are subject to the RED directive and must be certified. These requirements apply to both the product itself and the packaging. The purpose of the markings is to provide the end user with information about the product, such as compliance with the RED Directive, the manufacturer's identification, the product's serial number, and other specific information that may vary by product category. The exact requirements may vary depending on the product category and should therefore be carefully checked before certification.

Information obligations of the manufacturer

According to the RED directive, manufacturers must fulfill the following information requirements:

1. Technical documentation: The manufacturer must provide technical documentation proving the conformity of the product with the requirements of the RED Directive. This documentation must be available for presentation to the competent authority upon request.
2. Declaration of Conformity: The manufacturer must issue a declaration of conformity confirming that the product complies with the requirements of the RED Directive.
3. CE marking: The manufacturer must affix the CE marking to the product to indicate that it complies with European requirements.
4. User information: The manufacturer must provide instructions for use or other appropriate information to help the user use the product safely and effectively.
5. Traceability: The manufacturer must ensure that the product is clearly identifiable in order to take a quick and effective action in case of recall or traceability.

What documentation is required for RED certification?

The following documents are required for RED certification

• Declaration of Conformity
• Technical documentation
• Product description
• Test reports
• Certificates and reports from testing laboratories
• Serial number or batch identification of the product
• Technical documentation on software or firmware (if applicable)
• Instructions for installation, operation and maintenance
• Risk assessment documentation
• Privacy and security documentation (if applicable)

What happens if a product does not meet the RED certification requirements?

If a product does not meet the requirements of the RED Directive, it cannot bear the CE mark and may not be sold in Europe. The manufacturer is obliged to remove the product in question from sale and, if necessary, to launch recall actions. The manufacturer may also face penalties and fines and, in the worst case, may be liable for damages caused by the non-compliant product.

Are there any exceptions to the RED certification requirement?

There are certain exemptions from the RED certification requirement. For example, products that are manufactured specifically for export outside the European Economic Area (EEA) and do not return to the EEA are exempt from RED. Products intended solely for use by the armed forces or law enforcement may also be exempt from the certification requirement. Exemptions from the certification requirement may vary from country to country, and the manufacturer must ensure that its product is indeed exempt from the certification requirement before placing it on the market.

Do the RED rules apply when products are placed on the market or imported?

The rules of the RED Directive apply both to products placed on the market in the EU and to products imported from third countries. This means that manufacturers must ensure that their products meet the requirements of the RED Directive before they are placed on the market or imported.

What are the consequences of not complying with the RED regulations?

Failure to comply with the RED regulations may result in various consequences. Manufacturers who sell their products on the European market without the required RED certification may be required by national authorities to recall or remove their products from the market. In addition, high fines can be imposed and, in the worst case, even criminal penalties can be threatened. Damage to the reputation of the company and the products concerned cannot be ruled out either.

How often do RED certified products need to be tested to ensure they are still compliant?

There are no specific requirements for the periodic inspection of RED-certified products to ensure their conformity. The responsibility for maintaining conformity lies with the manufacturer, who must ensure that the product continues to meet the requirements of the RED directive. The manufacturer should conduct periodic reviews and retest as necessary when the product is modified or new standards or requirements are introduced that could impact compliance. In some cases, verification by a certification body may also be required, especially if there are changes to the product that could affect conformity.

What are the main changes in the new RED Directive 2014/53/EU compared to the old R&TTE Directive?

The new RED Directive 2014/53/EU replaced the previous R&TTE Directive and brought some important changes. Among the most important are:

1. Extended scope: The RED directive applies not only to telecommunications equipment, but also to all products that use wireless communication, such as machines and toys.
2. New requirements for radio modules: The RED directive introduced new requirements for radio modules, which must be certified separately.
3. Conformity assessment procedures: The RED Directive introduces new conformity assessment procedures to ensure that products comply with the requirements.
4. Harmonized standards: The RED Directive requires the use of harmonized European standards to facilitate compliance.
5. Greater emphasis on market surveillance: The RED Directive emphasizes the importance of market surveillance and strengthens the role of national authorities in enforcing the Directive.

Which frequency ranges and standards are covered by the RED directive?

The RED Directive covers a wide range of frequency bands and standards used in Europe. These include, for example, the GSM, UMTS and LTE mobile communications standards, WLAN and Bluetooth technologies, radio and TV frequencies, satellite communications, intelligent transport systems and wireless control and regulation devices. The exact requirements vary depending on the product type and are specified in the harmonized standards and the technical documents of the RED Directive.

Are there special requirements for wireless devices used in vehicles or medical facilities?

Yes, there are specific requirements for wireless devices used in vehicles or medical facilities. The RED directive defines additional requirements for these devices to ensure that they operate safely and without interference.

For devices used in vehicles, for example, special electromagnetic compatibility (EMC) requirements must be met to ensure that the device does not cause unwanted interference and is not itself disturbed by other electronic devices in the vehicle. In addition, the devices must be able to cope with the various temperature and vibration conditions in the vehicle.

Special requirements also apply to devices used in medical facilities. These requirements primarily concern electromagnetic compatibility (EMC) and the safety of medical devices. It must be ensured that the wireless devices do not cause unwanted interference in the vicinity of medical equipment and that they are able to function in an environment with high electromagnetic interference without endangering the patients or the medical equipment.

What are the differences between a declaration of conformity and a certificate under the RED Directive?

The declaration of conformity and the certificate are both documents that certify to manufacturers that their products comply with the requirements of the RED Directive. The main difference is who issues the document. The declaration of conformity is issued by the manufacturer itself and states that the product complies with the requirements. The certificate, on the other hand, is issued by a Notified Body, which has tested the product for compliance with the requirements and certified conformity. Another difference is that the certificate is required in some cases to place the product on the market in certain countries, while the declaration of conformity is usually sufficient to place the product in the European Economic Area.