MDD/CE certificates for specific product or product category?

A

Asherlee

#1
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
 
Elsmar Forum Sponsor
A

Alexisss

#2
Asherlee,

If I remember well, you must notify your NB for all changes in your technical file. Even in the case of your new product, even if it falls under the same category, you must notify the amendment to your technical file regarding the label. Otherwise, you may find your self selling excuses such as "we thought that it was not needed, because it was like the other products" etc...

Even if there is no risk of harm, even if the change to your technical file is minor, it is good to let them know so that they feel more confident with your system :)
 

Peter Selvey

Staff member
Super Moderator
#3
Under Annex II (Class IIa or IIb), it is only required to report changes to the quality system or product range for pre-approval, not changes to the the product itself of addition of new products within the range (see Annex II, Section 3.4).

This is further clarified in NBOG BPG 2009-4, see Section 9.

According to NBOG BPG 2006-2 on the content of certificates, NBs are required to know what products are covered by thier certificate, even if the models are not listed on the certificate itself. Therefore, it seems a good idea to provide an updated list of CE marked models under the scope of the certificate.

However, the NB should not require a pre-market technical file review for every notification. Per NBOG BPG 2009-02, prior to each audit, the NB should be looking at the list and preparing a sampling plan. For Class IIa devices, this is only one device per group. Such a sampling plan would make no sense if everything has been "pre-approved".

Hope this helps.
 
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