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醫療器械包裝全球法規和標準相關信息的更新

杜邦醫療與醫藥包裝 | 2021-12-02

2017年5月5日，歐盟官方期刊Official Journal of the European Union正式發布了歐盟醫療器械法規（MDR），以取代現行醫療器械指令（MDD）。法規過渡期設為3年，其中的醫療器械指令MDD93/42/EEC和有源植入醫療器械指令AIMDD 90/385/EEC，定于2020年5月26日終止，屆時MDR涵蓋的相關產品都必須滿足新法規要求，否則無法在歐盟國家上市。

然而，因為最近幾個月所爆發的COVID-19疫情，該法規的執行時間將會因此而有所變化，杜邦醫療與醫藥包裝業務全球法規和標準總監Thierry Wagner先生特此為大家分享了與此相關的一些最新進展。

杜邦醫療與醫藥包裝業務全球法規和標準總監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，杜邦醫療與醫藥包裝業務全球法規和標準總監。

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.

如你所見，目前我和很多人一樣在家工作，但我比以往任何時候都忙。和其他人一樣，我正在密切關注全球疫情的發展，并盡我所能支持公司生產杜邦防護服和杜邦? Tyvek? 醫療包裝材料產品以滿足市場需要。

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，醫療包裝法規和標準方面有很多快速的發展和變化，我想就此分享并強調一些我的觀察和想法。正如你們多數人已經看到的那樣，歐盟委員會已經啟動了推遲執行MDR的進程。這絕對是正確的做法，以便每個人都能把重點放在緊急優先事項上。這樣，MDD將再有效一年，但仍需歐盟議會和歐盟理事會正式頒布。

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.

歐盟委員會還決定將一些修訂后的標準與MDD進行協調，并宣布MDD協調后的標準有效期至2024年。其中的醫療包裝標準，EN ISO 11607仍然是2006版本。另一方面，EN ISO 11607修訂版自2020年1月發布，6個月后的2020年7月，行業和公告機構應將其視為最新版本。因此，我們將不得不更長時間地習慣這種我們已經多年面對的脫節了。

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，我們聽到成員國經過兩年的討論后通過了MDR標準化請求草案，但仍需CEN/CENELEC接受。如果接受，MDR協調標準就可以被正式采納，包括將來被歐盟協調標準顧問系統接受的、EN ISO 11607的修訂版本。”

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終將到來，因此合規和制定統一標準的努力不應有絲毫懈怠，我們只是為合規獲得了更多的時間，并可以把重心放在目前的疫情應對上。

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.

當我看到各地積極投入疫情的應對工作時，我看到了希望，特別是當我最近讀到有超過30種候選疫苗準備進行測試時。

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

保持聯系。祝大家安全，保重！我們團結一心，就會更強大。謝謝！

相關鏈接：

Proposal to postpone MDR:

https://ec.europa.eu/health/sites/health/files/docs/20200325_news_md_en.pdf

Implementing decision on standards:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2020:090I:FULL&from=EN

MEDTECH Europe letter:

https://www.medtecheurope.org/wp-content/uploads/2020/03/Statement-MedTech-Europe-MDR-and-IVDR-on-COVID19-23-March-2020.pdf

Latest published draft standardization request:

https://ec.europa.eu/docsroom/documents/36104/attachments/1/translations/en/renditions/native