• (0)
    Full text of EU MDR (Medical Device Regulation)

    Article 84 – Post-market surveillance plan

    The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices other than custom-made devices, the post- market surveillance plan shall be part of the technical documentation specified in Annex II.

    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