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  • CE marking obtaining the certificate, EU requirements

    CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking. Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it.

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  • List of Notified bodies accredited for Medical Device CE

    A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. 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

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  • COVID 19 Response PPE BSI

    Apr 14, 2020 · BSI has made a series of European Standards (ENs) for medical devices and personal protective equipment (PPE) used in the context of the current COVID 19 outbreak available without charge on its website. The standards, which cover face masks, medical gloves and protective clothing.

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  • Masks vs. RespiratorsExperts Explain COVID 19

    Feb 13, 2020 · In its newly published infection prevention and control recommendations for COVID 19, the US Centers for Disease Control and Prevention (CDC) recommends the use of N95 respirators in a healthcare setting with the suspected novel coronavirus, but the World Health Organization (WHO) has recommended surgical masks for general patient care and respirators for aerosol generating

  • FAQ on Face masks production, requirements, testing and

    Medical masks have to meet the requirements of the Medical Device legislation and comply with standard EN 14683Medical face masks Requirements and test methods and shall have a CE mark. Currently, it is not necessary to contact a notified body (which is