MDR 是對《醫(yī)療器械法規(guī)》的統(tǒng)稱。該規(guī)范于 2017 年 5 月 25 日生效,是在醫(yī)療器械合規(guī)性重新評估范圍內(nèi)引入的一項(xiàng)安排,盡管其合規(guī)性之前已獲得認(rèn)證。該規(guī)范旨在確定醫(yī)療器械是否符合新系統(tǒng)。?
More機(jī)械 CE 認(rèn)證是在歐盟規(guī)定的條件框架內(nèi)進(jìn)行的認(rèn)證過程。該認(rèn)證旨在避免在機(jī)械的生產(chǎn)、組裝和使用過程中出現(xiàn)可能威脅人類健康和環(huán)境的負(fù)面因素。該證書證明機(jī)械設(shè)備在環(huán)境和人類健康方面符合適當(dāng)?shù)臈l件。
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