What types of medical devices require conformity assessment conducted by a notified body?

The following devices require conformity assessment by a notified body:

• Class I sterile/measuring medical devices
• Class A sterile in vitro diagnostic devices
• Class IIa medical devices
• Class B in vitro diagnostic devices
• Class IIb medical devices
• Class C in vitro diagnostic devices
• Class III medical devices
• Class D in vitro diagnostic devices