Page History

Class

Characteristics

Events

Class I

Lowest risk

Draw up Technical File (TF), see section 8.2.7 Technical File (TF)
Registration with Competent Authority.
Self-declare CE and put on the EU market
Execute Post Market Surveillance (PMS), see section 8.2.8 Post Market Surveillance
(Unannounced) audits by Competent Authority

Class Is

Sterile device

Draw up Technical File), see section 8.2.7 Technical File (TF)
Submit Technical File to Notified Body.
Notified Body certificates CE.
Put on the EU market
Execute Post Market Surveillance, see section 8.2.8 Post Market Surveillance
Notified Body audits yearly & unannounced.

Class Im

Device with measuring function

Class IIa

Medium risk

Class IIb

Medium to high risk

Class III

Highest risk