News on Medical Devices

News on Medical Devices

A new version of the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES has recently been published by the EU Commission (version 1.22, 05-2019). This new version includes three additional typified cases, namely: Automated external defibrillator storage units, Lubricants intended for alleviation of vaginal dryness and Medication decision support software.

You can find this new version of the Manual here: https://ec.europa.eu/docsroom/documents/35582.

If you need any support or have any further question related to Borderline Medical Devices, please contact us at [email protected]

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