Need advice on how to obtain CE marking for Class II B medical equipment under our own brand which are assembeled completely based on SKD or CKD parts purchased from an OEM which has already its own CE marking for the finished product. Should we follow the Own Brand labeling (OBL) directive, or there is another directive that we need to follow? Please inform which directive we need to follow.

Need advice on how to obtain CE marking for Class II B medical equipment under our own brand which are assembeled completely based on SKD or CKD parts purchased from an OEM which has already its own CE marking for the finished product. Should we follow the Own Brand labeling (OBL) directive, or there is another directive that we need to follow? Please inform which directive we need to follow.

Welcome :bigwave:

I have moved your question to the CE section to get focussed responses. Btw, what is the expanded form of SKD and CKD ?

Does it stand for 'Semi Knock Down’ and ‘Complete Knock Down’ or 'scheduled' and 'checked' ?

Hi Ajit,

Thank you for your response. As you guessed correctly, SKD stands for "Semi Knock Down" and CKD stands for "Complete Knock Down". Thanks , shima parto:)