Recognition of EU certificates for medical devices: prospects and opportunities


Quality management // № 09 / 2023, September

The procedure for assessing the conformity of medical devices through the recognition of EU certificates is one of the possible ways to introduce medical devices into circulation in conditions of war, pandemic or other force majeure circumstances that prevent conformity assessment bodies from conducting regular assessment procedures by visiting the manufacturer’s production facilities.

The text of the article is available only in Ukrainian

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