Medical device CE marking

MHRA issued guidance 2.0 on applying human factors to medical devices


MHRA has published an updated guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks. The updates are primarily around this guidance applying to Great Britain, changes in references to legislation and the introduction of the new UKCA mark.

The document can be downloaded in our library.

Source: MHRA