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когда встречается такая вещь, как device, обычно нужно смотреть на более широкий контекст. Это ваш? Cell-based medicinal products may incorporate structural components which independently are medical devices or active implantable medical devices. Those devices should meet the essential requirements laid down in Directive 93/42/EEC24 concerning medical devices and Directive 90/385/EEC25 on the approximation of the laws of the Member States relating to active implantable medical devices, respectively, and this information shall be provided in the marketing authorization application. In the case where a Notified Body has evaluated the device part, the result of this assessment shall be included in the dossier.
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