Conformity Assessment

Depending on the classification of medical devices, the manufacturer may choose between different ways of certification, or so-called “conformity assessment procedures”.

The following charts outline each of them:

• Class I medical devices (conformity assessment)
• Class I (sterile or with measuring function) medical devices (conformity assessment)
• Class IIa medical devices (conformity assessment)
• Class IIb medical devices(conformity assessment)
• Class III medical devices (conformity assessment)