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:
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:
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:
Special requirements include the following:
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:
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:
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.