uuringumeditsiiniseade

Terminological databases

ID 714397 Last modified 30.12.2004

Domain public healthmedical equipment - infrastructure

device intended for clinical investigation

kliiniliseks uuringuks mõeldud meditsiiniseade, mida kasutab pädev meditsiinipraktik, kelle juhtimisel tehakse meditsiiniseadme uuringut adekvaatses, patsiendi kliinilise uuringu keskkonnas kooskõlas paragrahvides 213–224 toodud nõuetega

any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment

uuringumeditsiiniseade

device intended for clinical investigation

Usage examples

... 'placing on the market' means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished ...

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