Class IIa
Short definition
Class IIa is the medium-low risk class of medical devices under Regulation (EU) 2017/745, whose conformity assessment requires the involvement of a notified body.
In plain language
It is the class immediately above Class I. Under Rule 11 of Annex VIII, software intended to provide information used to take decisions with diagnostic or therapeutic purposes is, as a rule, at least Class IIa. For this reason, software that suggests diagnoses or treatments is normally subject to stricter requirements than content used at the professional's discretion.