PROGRAM
Classification: medical device for IVD, RUO (research use only) and general laboratory equipment.
Conformity assessment through self-declaration
Conformity assessment performed by conformity assessment body:
Conformity assessment of medical devices through the recognition of EU certificates:
Declaration of conformity
Conducting of surveillance audits for issued certificates
Viktoriia Shevchenko, Head of Conformity Assessment Department of the Ukrainian Scientific Institute of Certification
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 […]
Read moreManagement of the healthcare institution No. 7 July 2023 The text of the article is available only in Ukrainian
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