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Articles Tagged: Borderline

Update to Manual on Borderline and Classification for Medical Devices Under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices

An update to the Manual on Borderline and Classifications under the MDR and IVDR has been published. The last update, version 2, was issued in December 2022, and since then has been updated to include the following devices: Root canal irrigation solutions, Temperature sensors embedded in orthopaedic devices for compliance tracking, System intended to produce ...

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