On 22 September 2017, the Technical Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment as approved by Resolution No. 139 of the Cabinet of Ministers of Ukraine dated 10 March 2017 (hereinafter referred to as the RoHS Technical Regulation) comes into force. This Technical Regulation has been developed on the basis of Directive 2011/65/EC and applies, among other things, to:
- medical devices, cables or spare parts for the repair of medical devices which are placed on the market from 1 January 2018;
- in vitro diagnostic medical devices, cables or spare parts for the repair of in vitro diagnostic medical devices which are placed on the market from 22 July 2018.
The Technical Regulation establishes the maximum concentration values for hazardous substances, exemptions from restrictions, obligations of manufacturers, their authorized representatives, importers and distributors, requirements for the Declaration of Conformity.
Under Article 11 of the Law of Ukraine ‘On Technical Regulations and Conformity Assessment’, products must meet the requirements of all applicable Technical Regulations in effect in order to be placed on the market. Therefore, the conformity with the RoHS Technical Regulation should be assessed in conjunction with the conformity with the ‘specialized’ Technical Regulations on medical devices (Cabinet of Ministers Resolution No. 753) and on in vitro diagnostic medical devices (Cabinet of Ministers Resolution No. 754).
The conformity assessment procedure must be carried out by the manufacturer or his authorized representative in accordance with Module A (internal production control procedure) of CMU Resolution No.95 on approval of conformity assessment modules used for the development of conformity assessment procedures and of the rules for the use of conformity assessment modules. After the procedure is completed, but before the product is placed on the market, a Declaration of Conformity must be drawn up, and the mark of conformity to the technical regulations must be affixed to the product.
NB! The Declaration of Conformity must be written in Ukrainian or translated; its approximate structure is provided in the Technical Regulation.
NB! The mark of conformity must be affixed to the finished equipment, or to its data plate, or to its packaging and accompanying documents.
The Technical Regulation lays down the responsibilities of the following economic operators:
- authorized representative of the manufacturer in Ukraine;
The manufacturer and his authorized representative must keep the technical documentation and the Declaration of Conformity at the disposal of the market surveillance authorities for 10 years after the electrical or electronic equipment has been placed on the market.
For 10 years following the placing of the equipment on the market, all economic operators must be able to provide the market surveillance authorities, on their request, with the information identifying the following:
- economic operators who have supplied them with equipment;
- and economic operators to whom they have supplied electrical or electronic equipment.
Cratia offers service of conformity assessment to national Technical regulation on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2). We have the necessary knowledge, experience and skills to carry out all the necessary works and activities. We will take responsibility for organization of the process and perform it in the shortest possible time.
We will provide:
- all necessary consultations regarding the requirements of Technical regulation RoHS2, list of necessary documents and their legalization requirements, scientific advices etc .;
- the professional expertise of the documentation;
- translations of necessary documents, including proofreading and notary certification if required;
- filling the documents according to legal requirements;
- drafting of Declaration of conformity to Ukrainian Technical regulation RoHS2.
- localization of package labeling and instruction for use (manual);