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3月7日，在最終版新法規(guī)剛發(fā)布兩個星期，歐盟28個成員國一致投票表決同意采用新版的醫(yī)療器械法規(guī)（MDR）和體外診斷器械法規(guī)（IVDR）。

醫(yī)療器械在我們生活中起著非常重要的作用。我們平時都會用到橡皮膏（膠布繃帶）或者會去補牙。我們知道那些曾身患重病還活著的人們多虧了醫(yī)療器械在診斷和治療上的幫助。新的法規(guī)會讓更多具有創(chuàng)新性和更加安全的器械上市，對拯救生命會帶來更大的幫助。

繼歐盟委員表決采用新法規(guī)后，歐洲議會將在四月份對新法規(guī)做最后的表決，之后會在歐盟的官方雜志上正式發(fā)布新法規(guī)。

考慮到整個時間線，新法規(guī)有望在2017年5月或者6月開始實行，醫(yī)療器械法規(guī)將在2020年全面實施而體外診斷器械在2022年全面實施。

With thattimeframe in mind, the regulations are expected to enter into force in eitherMay or June 2017, with the new rules becoming applicable in 2020 for devicesand 2022 for IVDs.

"Medicaldevices play a crucial role in all our lives. We all regularly use stickingplasters [adhesive bandages] or have dental fillings, and we know people whoare still alive thanks to devices that have helped in the diagnosis andtreatment of serious diseases. These new rules will do more to help save lives,by having more innovative and safer devices on the market," said MalteseMinister for Health Christopher Fearne.

With theadoption of the texts by the Council, the regulations will head to the EuropeanParliament for a final vote in April before being formally published in the OfficialJournal of the European Union.

The EU'snew rules governing medical device and?in vitro?diagnostics(IVDs) are one step away from being fully adopted.

OnTuesday, the 28 members of the Council of the EU unanimously voted to adopt the MedicalDevice Regulations (MDR) and In Vitro Diagnostics Regulations(IVDR), just two weeks after releasing the final texts?ofthe regulations.

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