Radio Equipment in Europe must comply with the Radio Equipment Directive. The RED directive specifies procedures in Annex I to VIII.
The technical requirements of the Radio Equipment Directive appear in the form of Essential requirements, included in Article 3 of Directive 2014/53/EU. Radio equipment shall be constructed so as to ensure:
Article 3.1(a): the protection of the health and safety of people and of domestic animals and the protection of property, including the objectives regarding safety requirements set out in Directive 2014/35/EU, but with no applicable voltage limit;
Article 3.1(b): an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU.
Article 3.2: that it effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.
Article 3.3: other requirements for certain categories of Radio Equipment.
There are three ways in which manufacturers and importers can ensure that a product complies with the essential requirements. Two of these require the intervention of a Notified Body.
- Module A – Internal production control: The manufacturer is responsible for drawing up the technical documentation (which must include proof of conformity testing to the relevant product standards), carrying out an internal production control and issuing a declaration of conformity. This module is only available where products have been tested, completely, to Harmonised Standards.
- Modules B + C – EU-type examination (B) and Conformity to type based on internal production control (C): Module B+C make the same demands on the manufacturer as module A, but a Notified Body is required (for module B) to examine the Technical Construction File and to issue an EU-type examination certificate for the product. The use of these modules is mandatory for the introduction into the EU market of any product that has not been tested, completely, to Harmonised Standards. They can also be used, on a voluntary basis, for products that have been tested to Harmonised Standards. Module B+C can only be used for the conformity assessment of a product type.
- Module H – Full quality assurance: The manufacturer implements and manages a quality system encompassing radio equipment design, testing and manufacturing processes, which is subsequently assessed, certified and monitored by a Notified Body through periodic audits of the manufacturing plant. This module permits the conformity testing of a whole range of products, even of several different product ranges, and also allows the Notified Body number to be shown alongside the product’s CE Marking.
Many countries worldwide that do not have their own Radio Type Approval regulations refer to European regulations (2014/53/EU), and require an EU-type examination certificate. Therefore when you want to introduce your product worldwide, then Modules B + C approach is recommended.
Once a product has been proved to comply with the essential requirements of the RED by means of one of the three paths defined above, the product shall be labelled with the CE mark.
The European Union publishes a list of current Harmonized Standards (HS) in the Official Journals (OJ). To get market approval to the European Union, your product must meet the essential requirements of the directive. The manufacturer must then issue a Declaration of Conformity (DoC) and label the equipment and package correctly. The CE mark may only be placed if the equipment fulfils all applicable directives. In case there are any restrictions of putting the equipment into market in any of the Member States, then the equipment shall be marked with an additional bookmark warning sign together with the initials of any of the Member States where there are restrictions.
If your product is an electrical or an electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, and you want to get your product on the EU market, then you will need to reach CE marking by meeting all the essential requirements.
Under the RED, Notified Bodies are empowered to assess the Technical Construction File and render judgements with regard to compliance to the Directive; which may lead to issuing EU Type Examination Certificates for radio transmitters, receivers and transceivers placed in the EU market. The types of equipment under the RED scope include all wireless radio equipment; including WiFi, Bluetooth, OFDM technologies, Digital Transmission Systems, Short Range Devices (SRDs), NFC, cellular GSM, UMTS, LTE, NB-IoT and any other radio equipment used for radio communication or determination. Harmonized standards listed on the Official Journal are commonly used for showing compliance with the CE Marking requirements of the RED. The alternative to testing to a harmonised standard is to use Non-harmonised standards and use the help of Notified Body to see if all essential requirements have been covered. Even in cases when harmonised standards have been used, it is acceptable and common to seek an EU Type Examination Certificate from a Notified Body for the purpose of marketing, quality control, internal procedure, independent verification of test reports, procurement issues and manufacturer confidence.
The Technical Construction File shall contain all relevant data or details to ensure that radio equipment complies with the essential requirements set out in RED Article 3. It shall, at least, contain the elements set out in RED Annex V. The technical documentation shall be drawn up before radio equipment is placed on the market and shall continuously be updated. The technical documentation and correspondence relating to any EU-type examination procedure shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.
Content of the Technical Construction File
Needed documents for the TCF
- General Application Form
- Authorization letter
- Declaration of Conformity
- Risk assessment
- Packaging information / Box Label information
- Label sample and location
- Internal Photos
- External Photos
- Test setup photos
- User manual
- Block Diagram
- Schematics
- PCB Layout
- Parts list
- RF Exposure Info/SAR
- Test report
Further explained
General Application Form
Document with the information as required on the certificate, applicant, manufacturer and equipment information.
Authorization letter
Declaration, in case applicant is different than certificate holder.
Declaration of Conformity
Draft or final version of the EU DoC are both acceptable.
Risk assessment
A risk assessment analyzing the possible risks and demonstrating how they are reduced to comply with the essential requirements.
Packaging information / Box Label information
Box label including CE and in case of restrictions information according RED article 10 Clause 10 information.
Label sample and location
A drawing of the Label including equipment model name, trademark, manufacturer’s address, CE mark (RED Article 10 Clause 7 information) and a picture or drawing of the location of the label on the product.
Internal Photos
Photos showing the complete inside of the product. Showing separately all PCB’s. At least one picture of the Radio Frequency parts without shielding. Please provide all photos in one document, if not available in test report.
External Photos
Photos of the equipment showing controls and overall appearance. Please provide all photos in one document, if not available in test report.
Test setup photos
Photos of the test setup, showing hoe the measurement material has been setup with the EUT.
User manual
User instructions including regulatory information according to RED Article 10 Clause 8 and either DoC RED Annex VI or simplified DoC text as described in RED Annex VII with a reference web site according to RED Article 10 Clause 9.
Block Diagram
Document shall show the model name and identify the main equipment functions such as oscillators and frequencies.
Schematics
Document with electrical diagrams of the equipment and including the model name.
PCB Layout
PCB Layout or component placement drawings including the model name and including the component layout with component references as used in the schematics and parts list.
Parts list
A list of components used including the equipment name and references as used in the layout and schematics.
RF Exposure Info/SAR
A SAR report or an RF exposure test report or declaration should be submitted. The RF test report should show compliance with efficient radio spectrum use essential requirements (Art. 3.2).
Test report
Reports showing compliance with RED Article 3.2 must be provided. Including module test reports, when manufactures uses compliant module and did not perform complete testing. Further if needed you can supply the Safety and EMC test report showing compliance with the Safety and EMC essential requirement (Art. 3.1 (a) and 3.1(b) respectively).
Product modifications
The manufacturer shall inform the Notified Body that holds the technical documentation relating to the EU-type examination certificate of all modification of the approval type that may affect the conformity of the apparatus with the essential requirements of the RED or the conditions for the validity of the certificate. Such modifications shall require additional approval.