Get 4 FREE months of Conformio to implement ISO 27001

Expert Advice Community

Guest

Medical devices

  Quote
Guest
Guest user Created:   Oct 19, 2022 Last commented:   Oct 20, 2022

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

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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.   

Quote
0 1

Comment as guest or Sign in

HTML tags are not allowed

Oct 19, 2022

Oct 20, 2022