欧盟:宽容的CE政策,对防疫用品的绿色通道！

欧盟:宽容的CE政策,对防疫用品的绿色通道！

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.。

2020.3.13日欧盟发布了COVID-19威胁范围内的合格评定和市场监督程序的（EU）2020/403建议。

整个建议书的核心是为了满足欧盟市场对个人防护设备（“ PPE”）（例如口罩,手套,防护工作服或护目镜）和医疗器械（例如口罩,探查手套和某些长袍）的日益增长的需求。

该建议书规定,在特定情况下,某些医疗器械和PPE可能会在COVID-19爆发的情况下在欧盟市场上出售,即使它们尚未贴有CE标志,表明其符合适用的法规和义务。

The Recommendation provides that under specific circumstances some medical devices and PPE may be made available on the EU market within the context of the COVID-19 outbreak, even if they do not yet bear the CE mark demonstrating conformity with applicable regulations and obligations.。

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