MDR Class 1 Self Certification - Competent Authority or Notified Body?

#1
Hi hoping someone can help me out with this -

We have determined that we are a Class 1 (non-sterile. non-measuring, non-resuable) device under the MDR. We have finished all required documentation. We have finished our Declaration of Conformity and are wondering for self certification:

Do we send the Declaration of Conformity to our Competent Authority (like under the MDD)? Or, do we send the Declaration of Conformity to a Notified Body?
 
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shimonv

Trusted Information Resource
#2
I think neither. Your EU rep and distributors (a.k.a. economic operators) should have it.
I suggest you verify this with your EU rep.
 

monoj mon

Trusted Information Resource
#3
You must have a technical file for it, right! Your EU Rep should have it and they should register your product in their country first. I would also suggest to talk to them.
 

Steve M

Starting to get Involved
#4
I agree with the above. You definitely need it in your technical file and your EU rep should have it or at the very least be made available to them without delay.
 
#5
You must have a technical file for it, right! Your EU Rep should have it and they should register your product in their country first. I would also suggest to talk to them.
Thank you.

Yes, we already have a Technical File that includes the Declaration of Conformity. I was asking about the next steps.

So what you're saying is that we need to register it in the EU Rep country first. So this is done through the Competent Authority?

Then, after it is registered in the EU Rep country, how does it get registered for all of the EU? Do we need to interact with a notified body, or will the Competent Authority do this for us?
 

monoj mon

Trusted Information Resource
#6
Thank you.

Yes, we already have a Technical File that includes the Declaration of Conformity. I was asking about the next steps.

So what you're saying is that we need to register it in the EU Rep country first. So this is done through the Competent Authority?

Then, after it is registered in the EU Rep country, how does it get registered for all of the EU? Do we need to interact with a notified body, or will the Competent Authority do this for us?
I have just realized, you have never said in your post whether you are based in EU or outside EU. My original response was assuming you are based outside EU. If that is true then I would suggest, you should talk to your EU-Rep first. It is them who would register your product in their country. For rest of the steps, usually they should walk you through. And I don't think you would need to register your product in each and every country in the EU. You can go through this blog for further understanding.

And if you are already in the EU, then you don't need to have a EU-rep as all of us are suggesting above. Other than appointing a EU-rep, in this case, rest of the steps should be same as explained in the above blogpost.
 
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