Class I Self-certification: Do’s and Don’ts under the EU MDR
The Class I medical device manufacturers are now focusing on transitioning from European Medical Device Directives (MDD) to Medical Devices Regulation (EU MDR) 2017/745. For the CE certificates issued under MDD before the implementation of MDR to remain valid until May 2024, this is applicable only under certain conditions. The devices that are under Class I are required to be compliant with MDR.