• (0)
    Full text of EU MDR (Medical Device Regulation)
    EU MDR Chapter 2 Article 23

    Article 23 – Parts and components

    1. Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States.
    2. An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.
    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