According to paragraph 2.13 of the Technical Regulations, Authorized Representative is any legal entity or individual - entrepreneur, a resident of Ukraine or registered in accordance with the legislation of Ukraine, representative of a foreign business entity, suitably having a properly validated authorized by the manufacturer can take legal action on its behalf by manufacturer obligations established by this Technical regulations.
Each manufacturer, whose products will be used on the territory of Ukraine, shall be the Authorized Representative in Ukraine.
The main function of the Authorized Representative is representation of the interests of foreign producers in Ukraine and the communication between the foreign manufacturer of medical devices and the Ukrainian market.
All functions, which the manufacturer places on its Authorized Representative in Ukraine, should be spelled out in the contract or power of attorney.
Responsibilities of the Authorized Representative are prescribed in the contract / authorization. As a general rule, it concerns the provision, transmission and storage of information and documentation.
For example, a standard Authorized Representative contract in the EU provides such Authorized Representative functions:
- Compostion of the Declaration of Conformity.
- Execution of conformity assessment, including the organization of the tests and the provision of competent authorities set of documents necessary for the carrying out of procedures. Control the passage of conformity assessment procedures.
- Implementation of the actions necessary to establish and maintain technical documentation - technical output file.
- Storage of the manufacturer’s technical documents, the Declaration of Conformity, Certificates of conformity assessment.
- Acting as a contact person of the manufacturer in issues related to compliance with applicable standards of production in the course of supervisory actions and measures authorities.
- Acting as a contact person of the manufacturer in consumer incidents, including participation in consumer examinations, tests, etc. Authorized manufacturer must not only inform the manufacturer of such incidents, but also participate in their analysis.
- Informing the manufacturer to change the standards, technical regulations relating to products manufacturer.
PE" Consulting service plus " offers “Authorized representative” service.
- Provides maximum protection of the interests of the manufacturer, in the case of all consumer incidents, such as the examination of products during the incident and its tests,
- Informs potential consumers of all qualitative and technical characteristics,
- Address and telephone number of our company will be placed on the packaging of medical devices;
- Selects a telephone number and an employee.
- Conducts post-marketing surveillance of medical products in Ukraine