Breathalyser speed to market24 Sep 2020 10:54
Interesting detail from the RNS (observation taken from SKIN BB)
Microtox BT is expected to be a Class 1 medical device[ii].
Class I Medical Devices
Medical devices class I have the lowest perceived risk. The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g., stethoscope; and, if it’s not sterile, nor measuring, e.g., corrective glasses. If your product is class I, and it’s not a sterile or measuring device, then all you need to do is to self-certificate it, and formally declare its compliance with the applicable requirements of the MDD via a written statement. If it’s a sterile or a measuring medical device, then you will need a Notified body assessment.
[ii] https://support.ce-check.eu/hc/en-us/articles/360008712879-Classification-Of-Medical-Devices-And-Their-Routes-To-CE-Marking.