Notified Body Approval of Change

[Philip B]

We need to set up and have in place an EU Authorised Representative by 1st January. We need NB approval for this change, which they view as 'substantial'. Despite having started the process with them earlier this year there has been zero progress to date. We intend to have everything in place by 1st January to meet regulatory requirements (labelling, agreements, procedures etc) but might not have NB approval by then. If we place products on the EU market in January without approval is this itself a regulatory breach or just a breach of 'conditions of contract' with the NB, (which I view as a lesser offence)? Grateful for your experiences, thanks.

 

[shimonv]

MDD Annex II (EC DECLARATION OF CONFORMITY / Full quality assurance system), section 3.4 says the following:
"The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manu- facturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment."

So, yes you are looking at a potential regulatory breach.

-Shimon

 

[twanmul]

MDD Annex II (EC DECLARATION OF CONFORMITY / Full quality assurance system), section 3.4 says the following:
"The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manu- facturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment."

So, yes you are looking at a potential regulatory breach.

-Shimon

Same within section 3.4 of Annex IV for the IVDD.

When we brought on our EU ARP, we put it through with our Notified Body, sending them examples of how the labels etc will look when the changes will be made and it was approved based on this (with only a few weeks turn-around time) and that we agreed to inform them of the actual date the proposed changes are implemented.
There shouldn't be a need for a regulatory breach if your NB are agreeable to look at what you're proposing, agree to an implementation date and follow up at next inspection.