U.S. companies can self-certify to the CE marking requirements of the Machine Directive by meeting the provisions of the directive whether they use European, international or U.S. standards. The manufacturer may affix the CE marking to his product once he's prepared a declaration of conformity, the certificate which shows the product conforms
Italy: Medical Masks Without CE Marking; 27 March 2020 Italy: Medical Masks Without CE Marking Manufacturers and importers are required to certify and prove, though a self-certification, that the relevant device complies with the efficacy and safety requirements established by Directive 93/42/EEC, implemented in Italy by Legislative Decree
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