Hi,
I wanted advice on CE marking for RUO products. Our product is intended to be used in academic institution and is a electrical device.
I have below queries:
1. Do we need to CE mark the product for electrical safety, EMC etc directives or we shall just label it RUO.
2. As per MEDDEV. 2.14/2 rev.1 , IVD GUIDANCE : Research Use Only products A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES( attached) , it says products shall be labelled only as RUO and CE marking as IVD should not be done. But do we need to CE mark the product under other directives as LVD, EMC, etc?
Thank you very much.
I wanted advice on CE marking for RUO products. Our product is intended to be used in academic institution and is a electrical device.
I have below queries:
1. Do we need to CE mark the product for electrical safety, EMC etc directives or we shall just label it RUO.
2. As per MEDDEV. 2.14/2 rev.1 , IVD GUIDANCE : Research Use Only products A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES( attached) , it says products shall be labelled only as RUO and CE marking as IVD should not be done. But do we need to CE mark the product under other directives as LVD, EMC, etc?
Thank you very much.