Device with radioequipment (RED)
The Technical Regulation on Radio Equipment was adopted by Resolution No. 355 of the Cabinet of Ministers of Ukraine dated May 24, 2017. The Technical Regulation was prepared on the basis of Directive 2014/53/EU of the European Parliament and of the Council dated April 16, 2014. Because in the EU it is generally accepted to refer to this Directive as “RED” (Radio Equipment Directive), we also use the term “RED Regulation” hereinafter to refer to the Technical Regulations on Radio Equipment.
What is covered by the RED?
Medical devices, medical devices for in vitro diagnostics, and active implantable medical devices that contain radio modules (Wi-Fi, Bluetooth, GPS, GSM, etc.) are subject to the RED Technical Regulation. Examples are an ultrasonograph with a wireless sensor, a blood glucose meter with a Bluetooth connection to a mobile phone, or an analyzer transferring data to a PC via Wi-Fi. Such medical devices, active implantable medical devices, medical devices for in vitro diagnostics must comply with not only the “main” medical Regulation but also with the RED Regulation.
By applying the mark of conformity, the Manufacturer or its Authorized Representative declares that the medical device complies with all Technical Regulations applicable to such a device.
Carrying out the conformity assessment procedures, applying additional labeling, issuing the Declaration of Conformity, and performing other necessary actions are the responsibilities of the Manufacturer, the Authorized Representative, and, in some cases, the importer (entity introducing the product into circulation).
Transition period and implementation
The RED Regulation came into force on April 1, 2018, which should be taken into account by Manufacturers, importers, and Authorized Representatives when putting into circulation the products containing radio modules in their structure.
The transition period was effective until April 1, 2019. During this period it was allowed to introduce to the market and put into operation radio equipment that did not pass the assessment procedure for compliance with the RED Regulation, however, comprehensively satisfying a number of conditions:
- Radio equipment was put into circulation before April 1, 2018;
- Radio equipment complies with the requirements of the Technical Regulations:
- a) On radio equipment and telecommunication terminal equipment (Resolution No. 679 of the CMU dated June 24, 2009);
- b) On electromagnetic compatibility of equipment (Resolution No. 1077 of the CMU dated December 16, 2015);
- c) On low-voltage electrical equipment (Resolution No. 1067 of the CMU dated December 16, 2015).
As of January 1, 2020, any transitional periods and exceptions have ended or are not in effect. If your medical device contains a radio module, it is required to carry out an assessment of compliance with the RED Regulation, which complements the “Medical Regulations”.
When carrying out the conformity assessment, designing labeling and performing other actions to put radio equipment into circulation, in addition to the RED Regulation and legislation concerning conformity assessment and control of non-food products, it is necessary to take into account a number of industry legislative enactments, such as:
- Law of Ukraine “On the Radio Frequency Resource of Ukraine”;
- Resolution No. 1208 of the Cabinet of Ministers of Ukraine dated December 15, 2005, “On Approval of the National Table of Radio Frequency Bands Allocation in Ukraine”;
- Resolution No. 514 of the Cabinet of Ministers dated September 5, 2014, “Some Issues of the Conversion of the Radio Frequency Resource of Ukraine in the Common Radio Frequency Bands”;
- Resolution No. 815 of the Cabinet of Ministers of Ukraine dated June 9, 2006, “On Approval of the Plan for the Use of Radio Frequency Resource of Ukraine”;
- Decision No. 18 of the National Commission for the State Regulation of Communications and Informatization (NCSRCI) dated January 12, 2012, “On Approval of Generalized Terms for the Use of Radioelectronic Equipment and Emitting Devices”;
- Decision No. 256 of the NCSRCI dated June 30, 2020, “On Amendments to Decision No. 18 of the NCSRCI dated January 12, 2012”;
- Decision No. 844 of the NCSRCI dated December 23, 2014, “On Approval of the List of Radioelectronic Equipment and Emitting Devices, the Operation of Which Requires a Permit to Operate Radioelectronic Equipment or Emitting Device”;
- Decision No. 117 of the NCSRCI dated March 17, 2020, “On Approval of the Regulation on the Procedure and Form for Maintaining the Register of Radioelectronic Equipment and Emitting Devices that Can Be Used within the Territory of Ukraine at Common Radio Frequency Bands”;
- Decision No. 78 of the NCSRCI dated February 13, 2018, “On Approval of the Procedure for the Import from Abroad and Sale in Ukraine of Radioelectronic Equipment and Emitting Devices”;
- and some others.
Essential requirements for radio equipment
The RED Regulation, like any other technical regulation, defines a list of requirements that must be considered when putting products into circulation. Please note that in a quantitative definition, the list of essential requirements for radio equipment, in comparison with the regulations on medical devices, is much smaller and conditionally includes: general requirements, which any radio equipment must meet, and special requirements, which are applicable to the radio equipment of certain type.
Therefore, the general requirements include the following:
- Safety requirements (ensuring health and safety protection for people, pets, property protection), taking into account the requirements of the Technical Regulation on Low-Voltage Electrical Equipment (LVE);
- Requirements for electromagnetic compatibility of radio equipment with other sources in accordance with the Technical Regulation on Equipment Electromagnetic Compatibility (EEC);
- Requirements for the effective use and maintenance of the radio frequency resource of Ukraine and avoiding harmful interference.
Special requirements include the following:
- Interaction with accessories and other radio equipment via networks;
- Confidentiality and personal data protection;
- Functions for accessing emergency services and fraud protection, facilitating the use of equipment by disabled persons, and downloading software that meets the RED Requirements in certain combination.
Ensuring compliance with the general requirements of the RED Regulation should be taken into account when designing the products and has no exceptions regarding the type of radio equipment, while special requirements are applicable to the types of equipment determined by the regulatory enactments of the central executive authority in the sphere of communications in particular radio technology.
Conformity assessment procedures
In order to confirm the compliance of radio equipment with essential requirements, the manufacturer should take into account all envisaged operating conditions of such equipment and assess the application of the standards of the voluntary evidence base of the RED Regulation. Demonstrating the conformity is carried out by the use of conformity assessment procedures or their combination and consists of the following actions:
- Internal manufacture control (in accordance with Appendix 1 to the RED Regulation) which does not include the participation of a conformity assessment authority;
- Type examination along with conformity to type based on internal manufacture control (according to Appendix 2 to the RED Regulation). The procedure provides for the involvement of a conformity assessment authority to check the type of radio equipment, but does not provide for visiting the manufacturing site;
- Full quality assurance (in accordance with Appendix 3 to the RED Regulation) which provides for the involvement of a conformity assessment authority and on-site visits.
When choosing a conformity assessment procedure, the Manufacturer should evaluate the application of standards listed in the national standards, frequency and regularity of amendments to the type of radio equipment.
Registration of radio equipment
The radio equipment registration procedure applies only to equipment with a low level of compliance with essential requirements. If the equipment is subject to registration, a special registration number assigned by the NCSRCI is applied to such a product.
Declaration of Conformity
The Declaration of Conformity is drawn up according to the structure provided in Appendix 5 to the RED Regulation and:
- Includes wording about the sole responsibility of the Manufacturer;
- Contains a list of all technical regulations that the products comply with;
- Includes references to national standards or applied technical specifications;
- Contains references to the type expert examination certificate and the designated authority that carried out certain types of work, and, if applicable, the corresponding conformity assessment procedure.
It is important to remember that if a certain type of product is subject to several technical regulations requiring drawing up the Declaration of Conformity, a single Declaration of Conformity should be drawn up. This Declaration of Conformity must indicate corresponding technical regulations, including information about their official publication. This single Declaration of Conformity can be drawn up in the form of a dossier.
Cratia company offers professional services for assessing the conformity of products to the requirements of the Technical Regulations. We have the necessary knowledge, experience and skills to carry out all required works. We will take lead on the management and organization of the process, and help you to carry out the procedure within short timeframes.
- All necessary consultations regarding the requirements of the Technical Regulations;
- Professional expert examination of the documents;
- Preparing the technical documentation and other national documents;
- Based on the Power of Attorney, we perform all the works to submit the Application and carry out the conformity assessment procedure in the appointed authority;
- Preparation of the Declaration of Conformity with the requirements of Technical Regulations;
- Designing the draft labeling (labels, packaging) and instructions (user manuals);
- We give you a package of the required Technical Documents for keeping by the Authorized Representative.