医疗器械包装全球法规和标准相关信息的更新

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医疗器械包装全球法规和标准相关信息的更新

2017年5月5日，欧盟官方期刊Official Journal of the European Union正式发布了欧盟医疗器械法规（MDR），以取代现行医疗器械指令（MDD）。法规过渡期设为3年，其中的医疗器械指令MDD93/42/EEC和有源植入医疗器械指令AIMDD 90/385/EEC，定于2020年5月26日终止，届时MDR涵盖的相关产品都必须满足新法规要求，否则无法在欧盟国家上市。

然而，因为最近几个月所爆发的COVID-19疫情，该法规的执行时间将会因此而有所变化，杜邦医疗与医药包装业务全球法规和标准总监Thierry Wagner先生特此为大家分享了与此相关的一些最新进展。

杜邦医疗与医药包装业务全球法规和标准总监Thierry Wagner先生

Hello，I am Thierry Wagner, leading the global regulatory and standards function at DuPont Medical & Pharmaceutical Packaging.

大家好，我是Thierry Wagner，杜邦医疗与医药包装业务全球法规和标准总监。

As you can see, I am working from home as so many of us, but I have been busier than ever. Like everybody else I am monitoring developments around the global pandemic and I am supporting my company in the efforts to deliver the needed supply with DuPont Personal Protective garments and DuPont™ Tyvek® medical packaging.

如你所见，目前我和很多人一样在家工作，但我比以往任何时候都忙。和其他人一样，我正在密切关注全球疫情的发展，并尽我所能支持公司生产杜邦防护服和杜邦™ Tyvek® 医疗包装材料产品以满足市场需要。

I would like to highlight a few observations regarding recent regulatory development that came at a fast pace. Most of you have seen that the EU commission has initiated the process to postpone the MDR implementation, absolutely the right thing to do so that everybody can focus on urgent priorities. With this, the MDD will be valid for one more year, but it still needs to be enacted by the Parliament and the Council.

近期，医疗包装法规和标准方面有很多快速的发展和变化，我想就此分享并强调一些我的观察和想法。正如你们多数人已经看到的那样，欧盟委员会已经启动了推迟执行MDR的进程。这绝对是正确的做法，以便每个人都能把重点放在紧急优先事项上。这样，MDD将再有效一年，但仍需欧盟议会和欧盟理事会正式颁布。

The EU commission also decided to harmonise several revised standards against the MDD and declared the MDD harmonised standards valid until 2024. For the standard for medial packaging, EN ISO 11607, this is still the 2006 version. On the other hand, the latest revision is from January 2020 and it should be considered state-of-the-art by industry and notified bodies in July 2020, 6 month later. So, we will have to live a bit longer with this disconnect that we have already since many years.

欧盟委员会还决定将一些修订后的标准与MDD进行协调，并宣布MDD协调后的标准有效期至2024年。其中的医疗包装标准，EN ISO 11607仍然是2006版本。另一方面，EN ISO 11607修订版自2020年1月发布，6个月后的2020年7月，行业和公告机构应将其视为最新版本。因此，我们将不得不更长时间地习惯这种我们已经多年面对的脱节了。

Yesterday then, we heard that the draft MDR standardization request has been adopted by the member states after 2 years of discussions, but it stills needs to be accepted by CEN/CENELEC. If accepted, MDR harmonised standards can be formally adopted including the future amendment to EN ISO 11607 if accepted by the HAS consultants.

昨天，我们听到成员国经过两年的讨论后通过了MDR标准化请求草案，但仍需CEN/CENELEC接受。如果接受，MDR协调标准就可以被正式采纳，包括将来被欧盟协调标准顾问系统接受的、EN ISO 11607的修订版本。”

The MDR will be coming eventually, so efforts to comply and to develop harmonised standards should not be paused, but we just have more time to comply and can focus on the pandemic.

MDR终将到来，因此合规和制定统一标准的努力不应有丝毫懈怠，我们只是为合规获得了更多的时间，并可以把重心放在目前的疫情应对上。

When I see the mobilization there, for me there is hope, especially as I was reading recently that there are over 30 vaccine candidates ready for testing.

当我看到各地积极投入疫情的应对工作时，我看到了希望，特别是当我最近读到有超过30种候选疫苗准备进行测试时。

Talk to you soon, stay safe, take care, together we are stronger, thank you！

保持联系。祝大家安全，保重！我们团结一心，就会更强大。谢谢！