On September 22, 2017, the Technical Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment approved by Resolution No. 139 of the Cabinet of Ministers of Ukraine dated March 10, 2017 (hereinafter referred to as the RoHS Technical Regulation) came into force. This Technical Regulation has been developed on the basis of Directive 2011/65/EC and applies, inter alia, to:
- Medical devices, cables or spare parts for the repair of medical devices put into circulation starting from January 1, 2018;
- Medical devices for in vitro diagnostics, cables or spare parts for the repair of medical devices for in vitro diagnostics put into circulation starting from July 22, 2018.
The Technical Regulation establishes the maximum allowable quantities of hazardous substances, exclusions from restrictions, obligations of Manufacturers, Authorized Representatives of Manufacturers, importers and distributors, and requirements for Declaration of Conformity.
According to Article 11 of the Law of Ukraine "On Technical Regulations and Conformity Assessment", to be put into circulation, the products must comply with the requirements of all effective Technical Regulations apply to these products. Therefore, the compliance with the requirements of the RoHS Technical Regulation should be evaluated along with the "specialized" Technical Regulations on medical devices (Resolution No. 753 of the Cabinet of Ministers of Ukraine) and medical devices for in vitro diagnostics (Resolution No. 754 of the Cabinet of Ministers of Ukraine).
The conformity assessment procedure is carried out by the Manufacturer or its Authorized Representative in accordance with Module "A" (internal manufacture control procedure) of Resolution No. 95 of the Cabinet of Ministers of Ukraine "On Approval of Conformity Assessment Modules Used to Develop Conformity Assessment Procedures and Rules for the Use of Conformity Assessment Modules." Following the completion of the procedure, but prior to putting the product into circulation, the Declaration of Conformity should be drawn up, and a mark of conformity to the technical regulations is applied to the product.
NB! The Declaration of Conformity is drawn up in Ukrainian or translated, and its approximate structure is provided in the Technical Regulation.
NB! The mark of conformity to the technical regulations is applied to finished equipment or to a plate with technical data, or to the packaging and accompanying documents.
The Technical Regulation describes the responsibility of the following business entities:
- Manufacturer’s Authorized Representative in Ukraine;
The Manufacturer and its Authorized Representative are obliged to keep the technical documentation and the Declaration of Conformity for 10 years after putting electrical or electronic equipment into circulation for submission to market surveillance authorities.
Within 10 years from the date of putting the equipment into circulation, all entities should be able to provide at the request of market surveillance authorities the information to identify:
- Entities that supplied them with equipment,
- And the entities to which they have supplied electrical or electronic equipment.
Cratia company offers the works to fulfill the requirements of the Technical Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment. We have the necessary knowledge and experience, we are well conversant in the legislative requirements, and we can help to correctly prepare a package of documents and carry out the procedure within short timeframes.
- All needed consultations regarding the requirements of the Technical Regulation, the list of required documents and the procedure for their legalization;
- Professional expert examination of the documents;
- Preparation of the Technical File according to the requirements of Technical Regulations;
- Preparation of the Declaration of Conformity with the requirements of Technical Regulations;
- Development of the draft package labeling and instructions (user manual);