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
... '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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