AMA on EUMDR with Chandler Thames

  • 6 September 2022
  • 4 replies
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What questions do you have on EUMDR? Drop them in the thread below and we’ll make sure they are addressed on the call with Chandler!
 

 


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If a company hasn’t transitioned to EU MDR already and they have product in Europe (sold and in use at customer sites) what are the implications? What will they have to do when their CE Mark and ISO 13485 certificates expire? 

I’m confused by terminology issuing entity UDI system to issue UDI and the “UDI database” (Articles 27 - 29).  Are these the same or is the UDI database in EUDAMED?  Would you summarize the use of this, or these two, databases, please?

Also, I read where Legacy devices are required to be registered in Eudamed by Nov. 26, 2022.  Is this accurate? 

Userlevel 1

Hi,  As we agreed yesterday I’m posting my question from yesterdays AMA here.  

Do you know any Notified Body that is accepting new submission now?  We are developing a new technology, class III, active, implantable medical device.  We are located in Europe, we did our search through the NANDO website and got in contact with all the NB that apply according to our product code (MDA 1010).  We haven't received answers from all of them yet, but some of them have already told us they are not accepting new submissions, and to contact them again in some time, so they are not even adding new costumers to the waiting list…

Thanks!! 

 

Also posting a question from yesterday’s AMA here:

Following on from medtechie’s question, if a company has product in use at customer sites in Europe and their CE Mark certificate expires next year, AND they’ve decided to delay or not transition to EU MDR, what are the implications to the product already on market? Can customers continue to use it after the CE Mark expires? Is there anything the company needs to bear in mind/consider?

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