Improve Medical (en)

The designated conformity assessment body Improve Medical, in its activities concludes agreements on the recognition of the results of conformity assessment with the largest notified bodies of the EU, accredited and approved in accordance with the relevant EU Directives.

These agreements provide Improve Medical clients with the opportunity to reduce technical barriers in the process of legalizing medical devices for compliance within Ukrainian Technical Regulations.

The signing of the recognition agreements is regulated by Art. 45 of the Law of Ukraine On technical regulations and conformity assessment.

The results of conformity assessment with the requirements of technical regulations carried out in another state are recognized and accepted in Ukraine if the conformity assessment procedures applied in this state (even if they differ from Ukrainian procedures) provide the same or higher level of compliance with the requirements of the relevant technical regulations as Ukrainian. conformity assessment procedures.

The results of the conformity assessment (test reports, conformity documents, etc.) with the requirements of technical regulations carried out in other states are recognized and accepted in Ukraine in accordance with the provisions of the current international treaties of Ukraine, providing for mutual recognition of conformity assessment results.

Designated bodies have the right to recognize and accept the results of the conformity assessment (test reports, documents of conformity, etc.) with the requirements of technical regulations carried out by foreign accredited conformity assessment bodies, based on agreements concluded with such bodies on the recognition of conformity assessment results,

if:

– national accreditation bodies that accredit conformity assessment bodies both in Ukraine and in another state, are members of an international or regional accreditation organization and / or have concluded a mutual recognition agreement with such an organization regarding the relevant types of conformity assessment activities;

– the designated body, based on the results of the conformity assessment (test reports, conformity documents, etc.) conducted by a foreign accredited conformity assessment body, applies the conformity assessment procedure or part of it and issues a conformity document provided for by this procedure, under its own responsibility .

Improve Medical systematically expands borders in cooperation with international conformity assessment bodies and currently has 22 agreements in its portfolio.

Improve Medical has signed contracts with notified EU bodies