Ukrainian Scientific Institute of Certification

The Ministry of Economy of Ukraine provided an explanation regarding the unilateral recognition of EС-certificates

20/05/2020

In early March 2020, the Association of Market Operators of Medical Devices (AMOMD™) sought professional advice on technical issues regarding legality and legality of assessing the conformity of medical devices to the requirements of relevant technical regulations by recognizing the results of conformity assessment carried out by notified bodies in the European Union from the Ministry for Development of Economy, Trade and Agriculture of Ukraine (Ministry of Economy), as the main technical regulator in the system of central executive authorities.

The Ministry of Economy in its letter dated May 4, 2020 № 3432-06/28337-07 stated that within carring out the conformity assessment procedure as defined in the technical regulations on medical devices, Ukrainian designated conformity assessment body, which recognizes certain work on conformity assessment 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 accredited conformity assessment body an agreement (contract) on recognition (both mutual and unilateral) of the results of conformity assessment work and within such an agreement (contract) on the basis of a document on conformity issued by a foreign notified body for conformity assessment, apply the conformity assessment procedure or part thereof and issue a document of conformity provided for in this procedure, under its own responsibility.

According to the Ministry of Economy, the conformity assessment procedures provided for in Directives №93/42/EEC, № 98/79/EEС and №90/385/EEС ensure the same level of conformity to the requirements of the technical regulations as the Ukrainian conformity assessment procedures provided for in: