record retention requirements for the technical file, Declaration of Conformity, and certificates shall be increased from 5 years to 10 years.implement a UDI system in accordance with Article 24, 26, and 28.CE Mark the product in accordance with Article 18.create and maintain a Declaration of Conformity in accordance with Article 17.create and maintain a technical file in accordance with Annex II & III.This requirement is defined in Article 52 and Annex XIII
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