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Medical devices
Are medical devices subject to the falsified medicines directive (tamper proof and individual serialisation) or are you aware if this is the long term plan for them to meet this requirement?
https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features
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Expert
Kristina Zvonar Brkić
Oct 20, 2022
No, medical devices are not subject to the falsified medicines directive. Implementing the UDI number and registration of the devices in the EUDAMED is a way to prevent falsified medical devices.
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Oct 19, 2022
Oct 20, 2022
Oct 20, 2022