According to the requirements of Medical Device Regulation, Class I (non-sterile, non-measuring, non-reusable surgical instrument) medical devices do not need involvement of a Notified Body, so there is no CE certificate from a Notified Body but only self-declaration.

In Medical Device Regulation MDR (2017/745), Article 52, Section 7, it is clearly stated that Class I devices in sterile condition or with measuring function or reusable surgical instrument shall involve Notified Body in order to obtain a CE certificate. Other Class I devices (such as non-sterile face mask and isolation gowns) only require CE technical documentation in accordance with MDR (7045/745) Appendix II and Appendix III and a self-declaration to mark CE.

The snapshots of the Regulation are as below: