A
To all,
In companies where I worked previously, our NB gave us a MDD/CE certificate which consisted of a generic “product category” followed by an addendum which listed the specific company products approved for CE marking. The NB of the company where I work now, has issued CE certificates with only the generic “product category”, but no list of specific company products.
We want to market a new Class IIa device in the EEC; the device is covered by an existing CE product category. We will notify the NB of the new device. Our QS is approved according to Annex II of the MDD.
Question: does the NB HAVE to review the CE Technical File of the new device in order for us to add the CE mark (with # of the NB) on the device; OR can we "argue" that because the product category and our QS are already approved, the situation is that a new CE Technical File is assumed to be compliant unless proven otherwise.
By the way, according to the new MDD Directive 2007/47/EC, the concepts of "placing on the market" and "putting into service" refer to each individual product and not to a type of device.
Thanks.
Asherlee
In companies where I worked previously, our NB gave us a MDD/CE certificate which consisted of a generic “product category” followed by an addendum which listed the specific company products approved for CE marking. The NB of the company where I work now, has issued CE certificates with only the generic “product category”, but no list of specific company products.
We want to market a new Class IIa device in the EEC; the device is covered by an existing CE product category. We will notify the NB of the new device. Our QS is approved according to Annex II of the MDD.
Question: does the NB HAVE to review the CE Technical File of the new device in order for us to add the CE mark (with # of the NB) on the device; OR can we "argue" that because the product category and our QS are already approved, the situation is that a new CE Technical File is assumed to be compliant unless proven otherwise.
By the way, according to the new MDD Directive 2007/47/EC, the concepts of "placing on the market" and "putting into service" refer to each individual product and not to a type of device.
Thanks.
Asherlee