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The National Health Institute and Confindustria Dispositivi Medici (the Italian Association of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of surgical masks for medical use not bearing the CE marking pursuant to Article 15 of Decree Law No. 18 of March 17, 2020, so ...

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After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Manufacturers can choose any notified body for conformity assessment (audit . Surgical face mask with soft earloop

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2020-3-25 · Applications for CE credentials are hardened as the number of applications surge with many Chinese medical supplies manufacturers looking at the EU market amid a …

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2020-4-2 · Generally speaking, surgical masks are classified as a Class I medical device. However, if your masks are sterile, then they classified as Class I (sterile) . Also, note that according to the 2007 amendment of the Directive , when the mask is designed to protect both the patient and the wearer, it shall comply with the PPE Directive as well.

Notified Body Services - Medical Device Certification

Medical Device Directives. In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC; or in the case of in vitro diagnostic medical devices, the In Vitro Diagnostics Directive (IVDD) 98/79/EC.. These CE marking Directives cover active ...