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Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put it simply – the recognition of EU certificates for medical devices.
The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]
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Read moreThe European Business Association invites you to a meeting dedicated to the current issues of updating technical regulations in the field of medical devices, which will be held on May 8 at 10:00. The new requirements will have a significant impact on manufacturers, importers, distributors, and authorized representatives of medical devices. Issues for discussion: Changes in […]
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