欧盟MDR和IVDR新法规：欧洲理事会一致通过，下一步是欧洲议会的表决

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欧盟关于医疗器械和体外诊断医疗器械（IVD）的新法规距离被完全采纳仅仅是一步之遥了。

本周二（2017年3月7日），在法规最终版本发布两个星期后，由欧盟28个成员国召开的欧洲理事会一致投票通过了医疗器械法规（MDR）和体外诊断医疗器械法规（IVDR）。

“医疗器械在我们所有人的生活中发挥着至关重要的作用。从小的方面说，我们都经常使用贴膏药（胶布绷带）或是补牙。从大的方面说，我们都知道，有些人的生命之所以得以延续，得益于可以诊断和治疗重大疾病的器械。通过在市场上投放更具创新性以及更安全的器械，这些新规则将会为拯救生命做出更多的贡献”，马耳他卫生部长克里斯托弗·费恩（Christopher Fearne）说道。

随着欧洲理事会的一致投票通过，MDR和IVDR新法规将于4月份送交欧洲议会进行最后一轮投票，然后正式在欧盟官方公报上公布。

按照时间表，MDR和IVDR新法规预计将于2017年5月或6月生效。MDR将与2020年开始施行，IVDR将与2022年开始施行（MDR和IVDR的过渡期分别为法规生效之日后的3年和5年）。

英语原文

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EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament

Posted 07 March 2017 By Michael Mezher

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

On Tuesday, the 28 members of the Council of the EU unanimously voted to adopt the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), just two weeks after releasing the final texts of the regulations.

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

With the adoption of the texts by the Council, the regulations will head to the European Parliament for a final vote in April before being formally published in the Official Journal of the European Union.

With that timeframe in mind, the regulations are expected to enter into force in either May or June 2017, with the new rules becoming applicable in 2020 for devices and 2022 for IVDs.

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内容来自：RAPS

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