Authorized representative

A legal entity or individual entrepreneur (sole proprietor) that represents the interests of a foreign manufacturer in Ukraine and is granted the authority by the manufacturer to carry out conformity assessments in accordance with the requirements of the Technical Regulations (where applicable).

The Authorized Representative is the person who interacts with competent authorities related to medical devices and ensures that the manufacturer complies with requirements concerning labeling, identification, and quality of medical devices.

The Authorized Representative ensures effective communication between the buyer, competent authorities, and the manufacturer in cases of complaints, market recalls of medical devices, and takes actions to bring the medical device into compliance with legal requirements.

The Authorized Representative is mandatory for medical device manufacturers that do not have a presence in Ukraine and is a crucial element in ensuring the safety and quality of medical devices on the market.

For Ukrainian manufacturers aiming to enter the European Union market and supply medical devices to European consumers, having an Authorized Representative in the European Union is necessary.