I. Definition & Purpose
The Radio Equipment Directive (RED) 2014/53/EU replaced the former Radio Equipment & Telecommunications Terminal Equipment Directive (R&TTED) 1999/5/EG, aligning it with the New Legislative Framework (NLF). The RED came into force on the 13th of June, 2016, but because of the granted transition period, both directives were still applicable until the 12th of June, 2017. Since the 13th of June, 2017, all products falling under the scope of RED 2014/53/EU have to comply with the respective RED requirements.
The Directive provides the essential legislative requirements, concerning consumers’ safety and health, and efficient use of products, for placing radio equipment on the EU market. The RED further includes a basis for protection of personal data, privacy and against fraud.
II. Scope
The Radio Equipment Directive 2014/53/EU has a broad range of products with radio components. However, the fact that a product has a radio element included within its design doesn’t always mean that it falls under the RED scope and needs RED compliance assessment. For instance, the following examples of products are not regulated by RED:
- Marine equipment that is regulated by the Council Directive 96/98/EC;
- Radio products used and/or constructed by radio amateurs;
- Airborne products, including parts and appliances, that are regulated by Regulation (EC) No 216/2008;
- Custom-built evaluation kits for research and development.
Products which does fall within the scope of the Directive are, for example, AM/FM radios and receivers, and TVs without radio modules.
III. General requirements for radio equipment placed on the EU market
To ensure a high level of product safety, the Radio Equipment Directive lays down two types of mandatory essential requirements, as follows:
- Essential requirements that apply to all radio equipment within the Directive’s scope;
- And, essential requirements that concern only a specific type of radio equipment.
The first group of essential requirements, i.e. those applicable to all radio products, are:
- The product shall not endanger the health and safety of persons, domestic animals and properties;
- The level of electromagnetic compatibility shall be within the appropriate limits;
- Any harmful interference caused by the radio spectrum shall be eliminated.
The second group of requirements, i.e. those valid only to a specific type of radio technology, apply to classes or categories of radio equipment indicated explicitly by the European Commission. Such essential requirements are, as follows:
- Features, such as access to emergency services and protection against fraud, shall be supported by product;
- The product works with accessories, e.g. common chargers, and via networks with other radio apparatus;
- The radio equipment can be linked to appropriate interfaces throughout the European Union;
- The radio equipment shall not misuse current network resources nor cause any harm to the network or degrade its functioning;
- Safeguards ensuring the protection of user’s personal data and privacy shall be incorporated within the device;
- The equipment shall include specific features that facilitate its use by people with disabilities;
- Etc.
IV. Obligations of the economic operators
According to what is stated in the RED, the economic operators that have obligations could be manufacturers, importers, distributors, and authorised representatives. However, the primary responsibilities, as always, are given to the manufacturer of the particular product. The duties of the other economic operators are built on those of the manufacturer.
To place radio equipment on the EU market, manufacturers of such products have the following obligations:
- The design and manufacturing of the product must be following the Directive’s essential requirements;
- The respective conformity assessment procedure must be carried out;
- To create a technical construction file;
- To draw up, as well as sign, a Declaration of Conformity which, afterwards, must accompany the radio equipment;
- To affix the CE mark on the product, as well as the notified body identification number, if there is one;
- To add identification serial number, type or batch on the product;
- The equipment must be accompanied by traceability and geographical information, along with safety information and instructions;
- To make sure the product will operate in at least one EU Member State;
- To ensure that all product units conform with the RED;
- If a product is not compliant and is already placed on the EU market, the manufacturer must take all appropriate actions to either provide compliance or withdraw it from the market;
- And, to be cooperative with the national market surveillance authorities.
When it comes to the authorised representatives, they need to:
- Keep the product’s technical file and Declaration of Conformity so that they can be provided to the national authorities upon request;
- Cooperate with the respective market surveillance authorities.
All importers, similarly to the manufacturers, have many obligations, including:
- To ensure that the radio equipment meets the respective essential requirements;
- To make sure that the manufacturer of the specific product has undertaken all necessary steps in regards to its CE compliance;
- Add their name or address, or any other traceability information to the apparatus;
- To ensure that the equipment is stored and transported under the right conditions without jeopardising its compliance;
- To take the appropriate actions in the event of non-compliant radio equipment;
- To keep a copy of the product’s technical file and Declaration of Conformity for ten years;
- To cooperate with the respective market surveillance authorities and, upon their request, to provide them with the necessary documents concerning the compliance of the product.
Last but not least, all distributors of radio equipment have the following responsibilities:
- To verify that the manufacturer has taken all the necessary steps regarding the CE compliance of the product;
- In the event of imported equipment, the distributor must check if the importer has added all the required information, such as their name, address, etc;
- To ensure that the product has been kept under the right storage and transport conditions and its compliance has not been jeopardised;
- To act immediately in the event of released non-compliant product on the EU market;
- To collaborate with the national authorities.
V. Conformity of radio equipment in accordance with the Radio Equipment Directive 2014/53/EU
The CE compliance process of any radio equipment that falls under the scope of the RED should include the following steps:
- Identification of all essential requirements applicable to the specific product;
- Conformity assessment procedure which ensures that the particular product complies with the essential requirements of the Directive. Usually, the RED conformity assessment takes into account all intended operating conditions and reasonably foreseeable circumstances;
- The product's compliance must be demonstrated by undergoing either internal production control, or EU-type assessment followed by the type-based conformity on internal product control, or full quality assurance conformity. Note that the first type of assessment procedure, i.e. internal production control, is possible if only harmonised standards have been used;
- Creation of a product’s technical documentation and a Declaration of Conformity;
- Affixing the CE mark on the product.
Do you have a product that needs to comply with the Radio Equipment Directive?
Get in touch with us at Clever Compliance to get the product testing you need. Our compliance store is the perfect place for any non-food product manufacturer or importer who wants to place a product on the EU market. But if you are a compliance specialist, then better check our compliance management system.
Comments
0 comments
Please sign in to leave a comment.