3月7日，在最终版新法规刚发布两个星期，欧盟28个成员国一致投票表决同意采用新版的医疗器械法规（MDR）和体外诊断器械法规（IVDR）。

医疗器械在我们生活中起着非常重要的作用。我们平时都会用到橡皮膏（胶布绷带）或者会去补牙。我们知道那些曾身患重病还活着的人们多亏了医疗器械在诊断和治疗上的帮助。新的法规会让更多具有创新性和更加安全的器械上市，对拯救生命会带来更大的帮助。

继欧盟委员表决采用新法规后，欧洲议会将在四月份对新法规做最后的表决，之后会在欧盟的官方杂志上正式发布新法规。

考虑到整个时间线，新法规有望在2017年5月或者6月开始实行，医疗器械法规将在2020年全面实施而体外诊断器械在2022年全面实施。

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.

关于卓远天成:

深圳市卓远天成咨询有限公司是一家从事医疗器械国际咨询的专业性咨询机构，可为您提供各个国家或地区医疗器械上市注册、医疗器械质量体系审查等多种国际注册及认证的咨询/代理服务。