GLOSSARYEU
Recall Classification (EU)
The EU MDR sets no recall classes. It defines a recall as returning a device already made available to the end user, and a withdrawal as stopping a device in the supply chain from being made available.
Terms the MDR defines instead
- Recall
- Any measure aimed at achieving the return of a device that has already been made available to the end user.
- Withdrawal
- Any measure aimed at preventing a device in the supply chain from being further made available on the market.
- Field safety corrective action
- Corrective action a manufacturer takes for technical or medical reasons to prevent or reduce the risk of a serious incident with a device on the market.
- Field safety notice
- A communication a manufacturer sends to users or customers about a field safety corrective action.
Avoid This Mistake
EU device classes I, IIa, IIb, and III are risk classes for devices under Article 51, not recall classes.