Take the ISO 13485 course exam and get the ISO 9001 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021
  • (0)
    Full text of EU MDR (Medical Device Regulation)
    EU MDR Chapter 2 Article 8

    Article 8 – Use of harmonised standards

    1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
    2. The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).

      References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.

    3. References in this Regulation to harmonised standards shall also include the monographs of the European Pharma­ copoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.
    IMPLEMENT ISO 13485 & MDR
    BY YOURSELF

    SEE HOW IT WORKS

    • Optimized for small and medium-sized companies
    • Costs up to 80% less than using consultants
    • Expert consultations and unlimited email support available
    • Created by Advisera, the leading website for compliance