Curious: what surveillance mechanisms exists for the conformity of Class I devices in the EU?
Unlike other classes of device, Class I devices have self-declared ER conformity, and can CE-mark without the involvement of a notified body (NB).
Given that there is no NB involved, does this mean no surveillance audits? If so, how is ER conformity of Class I devices policed?
I presume that any reportable events, advisory notices, recalls, etc. may trigger surveillance. But absent any such device issues, can a manufacturer of Class I devices expect any sort of surveillance/audits with respect to their self-declared CE-marked Class I devices?
MM.
Unlike other classes of device, Class I devices have self-declared ER conformity, and can CE-mark without the involvement of a notified body (NB).
Given that there is no NB involved, does this mean no surveillance audits? If so, how is ER conformity of Class I devices policed?
I presume that any reportable events, advisory notices, recalls, etc. may trigger surveillance. But absent any such device issues, can a manufacturer of Class I devices expect any sort of surveillance/audits with respect to their self-declared CE-marked Class I devices?
MM.