The RED is the legal document instructing the European Union member states on the regulatory framework for placing radio equipment on the market in the EU. As with other EU directives, it describes “essential requirements” for radio equipment. These essential requirements of RED are to ensure protection of health and safety, adequate electromagnetic compatibility (EMC) and effective and efficient use of the radio spectrum. Directives are not standards.
The Radio Equipment Directive is effective now. RED must be employed for all products included in its scope and not yet placed on the EU market after June 12, 2017. This means that even products that were already being sold as compliant with the R&TTED must comply with the RED to continue to be placed on the market after this date.
To comply with essential requirements of the RED, the easiest route is a self declaration relying on the use of harmonized standards to address the risks associated with the use of a product. A harmonized standard is a European standard that has been published in the Official Journal of the EU. These are typically developed by recognized European Standards Organizations: CEN, CENELEC, or ETSI. A presumption of conformity with the essential requirements is afforded and additional measures are not required when harmonized standards are used and the risk analysis findings indicate that using the harmonized standards cover the risks.
There are some standards that are harmonized (i.e. listed in the Official Journal of the EU) for the efficient and effective use of the radio spectrum. Harmonized standards do not exist for all product types nor are there any harmonized standards for EMC and Safety. This means that some other means must be employed to demonstrate compliance. The RED addresses this with a risk assessment. This risk assessment is used to determine how normal and foreseeable uses are accounted for in selection and use of standards to demonstrate compliance with the essential requirements. For example, in the case of EMC, the risk assessment may determine that a standard harmonized for the EMC directive covers all the EMC risks.
If harmonized standards are not available for the efficient and effective use of the spectrum, a notified body must be included in the evaluation of compliance with the essential requirements. This takes the form of an evaluation of the product for portions (or all, if desired) of the essential requirements and then issuance of a Type Examination Certificate by the notified body. The list of harmonized standards for directives is published in the official journal of the EU and at https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte_en.
It should be noted that harmonized standards for the RED are not the same as those harmonized for the R&TTED. Primarily this is due to the inclusion of receiver performance in the scope of the RED. For the R&TTED, receiver performance was a non-mandatory quality issue but is required by the RED. For products that were evaluated using standards for the R&TTED, it is not necessary to repeat testing for requirements that are unchanged in the standards for the RED.
If a Type Examination is needed, the follow items should be provided with a request to a Notified Body evaluation
Some of the other changes in the RED compared to the R&TTED are in the application of the CE mark, alert symbol and Notified Body number and country notifications. For the RED, the CE mark is required on the product and the packaging but not in the user instructions. No alert symbol is used in the RED, instead, a diagram is to be used on the packaging and in the user instructions indicating country restrictions. A notified body involvement for the R&TTED meant that the number of the notified body was part of the product labeling. For the RED this is only true if a notified body is used for a Full Quality Assurance assessment for compliance with the RED. A notified body number shall not be used if a type examination assessment by a notified body is employed. The user instructions are also required to have technical information about items that can be installed or changed by a user such as antennas to be used or software to be used. The RED also allows a simplified form of the Declaration of Conformity (DoC) instead of the complete version provided with the product along with the information on how to access the complete DoC.