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)

    Article 58 – Voluntary change of notified body

    1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
      1. the date on which the certificates issued by the outgoing notified body become invalid;
      2. the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;
      3. the transfer of documents, including confidentiality aspects and property rights;
      4. the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;
      5. the last serial number or lot number for which the outgoing notified body is responsible.
    2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.
    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