Once the all the previous items are in place:

• Class A sterile, Class B, Class C, or Class D devices must engage a Notified Body to CE Mark the device. The Notified Body will conduct an audit, and upon successful completion, issue a CE certificate. The Notified Body’s 4-digit number will be placed adjacent to the CE symbol.
• Class A non-sterile devices do not require Notified Body review. Instead, the manufacturer will ‘self-affix’ the CE symbol to the device labeling.