Withdrawal

A withdrawal acts on devices not yet with the end user, while a recall reaches devices already made available to them. The EU withdrawal is not the same as an FDA market withdrawal, which concerns products with a minor violation or none.

‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;

EU MDR, Article 2(63)

‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;

IVDR, Article 2(66)