MDR Requirments

New EU MDR Important Instruction to Manufacturers

1. Explanation of Chapters in MDR




2. MDR Technical Documentation Route Slection




3. MDR Selection of Applicable Rules based on Risk Class of the Medical  Device

Rules 1 - 4: Non-invasive devices (in comparison with MDD)

Rules 5 – 8: Invasive devices (in comparison with MDD/AIMD)

Rules 9 – 13: Active Devices (in comparison with MDD/AIMD)

Rules 14 – 18: Special rules

Rules 19 – 22: Special rules




4. MDR Conformity Assessment route against risk classification




5. Regulation EU 2017/745 – Conformity Assessment

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