Clarification of the Ministry of Economy of Ukraine regarding the recognition of certificates of conformity

The Ministry of Economy in its letter dated 04.05.2020 № 3432-06 / 28337-07 indicates that the Ukrainian designated conformity assessment body performs the conformity assessment procedure defined in the Technical Regulations for Medical Devices, which recognizes certain conformity assessment works directives of the European Union, conducted by a European notified body, on the basis of a contract (agreement) on recognition with such a body, ensures compliance with the Ukrainian designated body for conformity assessment of the Law of Ukraine "On Technical Regulations and Conformity Assessment". The Ministry of Economy considers that the Ukrainian designated conformity assessment body has the right to conclude with a foreign notified body for conformity assessment an agreement (contract) on recognition (both mutual and unilateral) of the results of conformity assessment and apply conformity assessment procedures or part thereof and issue a certificate compliance provided for in this procedure.