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Eudamed actor registrstion module

  • 1.  Eudamed actor registrstion module

    Posted 07-May-2021 04:12
    Hi all, just a curiosity question.
    Has anyone experience yet of registering in the actor registration module and receiving their SRN? If yes, how long did it take/which CA?

    ------------------------------
    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
    ------------------------------


  • 2.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 03:14
    In my case, the competent authority was filled in automatically as the one in Belgium: FAGG

    The CA should be the one where the manufacturer, or in case of distribution, the distributor, is located

    Greetings,
    Franky

    ------------------------------
    Franky Dubois
    QA/RA Manager
    FEops
    Gent
    Belgium
    ------------------------------



  • 3.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 04:08
    Thanks. I was wondering if there was a delay before receiving your SRN?

    ------------------------------
    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
    ------------------------------



  • 4.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 04:59
    No, you get the SRN immediately when submitting

    The CA can make objection, later if needed

    ------------------------------
    Franky Dubois
    QA/RA Manager
    FEops
    Gent
    Belgium
    ------------------------------



  • 5.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 05:04
    Thanks. Much appreciated.

    ------------------------------
    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
    ------------------------------



  • 6.  RE: Eudamed actor registrstion module

    Posted 11-May-2021 11:42

    Dear Franky, 
    how did your SRN look like? I am based in Belgium too, but all I got after EUDAMED registration is a a cryptic message line:

    "ACT-004.02-20210310-APP000005670: Actor Registration Request Assessment Performed"
    An actor registration assessment has been performed in EUDAMED.
    The competent authority Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten, Belgium has verified and approved your registration request. Following this approval, the competent authority has decided to issue a unique Single Registration Number (SRN) to your entity. The registration request ID is APP000005670

    But these numbers do not seem to do anything in EUDAMED. I cannot find my own company back, nor add any additional users. And the FAGG famous help desk is as usual totally unhelpful. Did you get anything more from them? 



    ------------------------------
    Agnieszka Swiatek
    Regulatory Affairs Manager
    Aptec Diagnostics
    Sint-Niklaas
    Belgium
    ------------------------------



  • 7.  RE: Eudamed actor registrstion module

    Posted 12-May-2021 02:56
    Our SRN is  BE-MF-000001008, With "BE" for "Belgium", "MF" for manufacturer and then the number

    ------------------------------
    Franky Dubois
    QA/RA Manager
    FEops
    Gent
    Belgium
    ------------------------------



  • 8.  RE: Eudamed actor registrstion module

    Posted 12-May-2021 05:42
    By going to the public site of Eudamed, I found your company (Aptec Diagnostics) in 1 second.

    Manufacturer, BE-MF-000001985, APTEC Diagnostics NV - [Belgium]



    ------------------------------
    Robert van Boxtel
    Principal Consultant Medical Device Project B.V.
    MDProject
    Alphen a/d Rijn
    Netherlands
    ------------------------------



  • 9.  RE: Eudamed actor registrstion module

    Posted 12-May-2021 07:29
    Thanks Robert! Me too! I expected some sort of message from EUDAMED, but seems everything happened automatically. So far so good:-)

    ------------------------------
    Agnieszka Swiatek
    Regulatory Affairs Manager
    Aptec Diagnostics
    Sint-Niklaas
    Belgium
    ------------------------------



  • 10.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 07:51
    I submitted our actor registration at the end of March. It was verified by our AR within a week. As of today, the registration sits at verified. If I understand correctly, I should receive an email with our SRN when the final approval is completed. So, we're more than a month in and still waiting.

    ------------------------------
    Timothy Roloff
    Regulatory / Quality Manager
    NeoSoft LLC
    Pewaukee WI
    United States
    ------------------------------



  • 11.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 08:31
    Thanks for sharing your experience Tim. In which country/CA?

    ------------------------------
    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
    ------------------------------



  • 12.  RE: Eudamed actor registrstion module

    Posted 10-May-2021 08:38
    It's the Netherlands and the CA is: Ministerie van Volksgezondheid, Welzijn en Sport. I've contacted them and our AR for updates.

    ------------------------------
    Timothy Roloff
    Sr. Regulatory / Quality Engineer
    NeoSoft LLC
    Pewaukee WI
    United States
    ------------------------------



  • 13.  RE: Eudamed actor registrstion module

    Posted 11-May-2021 08:34

    To use the standard RA response "IT DEPENDS"

    The German response from BfArM is that the SRN can be first issued on the date of application of the MDR. I submitted our AR and Importer applications on Dec.10th 2020, today, 11.05.2021, I received a correction request as the company address was considered to be incorrect. I had used "Cologne" as the cities name in our address, thinking this would be widely understood in Europe. My competent authority, which is based in this city, required me to correct the address to show the German spelling Köln. I am pleased that our company isn't based in Lüttich, or should that be Liege? �� Although at least then the Belgian authorities might have issued an SRN!

    Anyway, our company address on our actor registration application has now been corrected and I know someone somewhere is processing our application.

     

    Kind regards,

     

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  • 14.  RE: Eudamed actor registrstion module

    This message was posted by a user wishing to remain anonymous
    Posted 11-May-2021 13:29
    This message was posted by a user wishing to remain anonymous

    Hi Timothy, 
    This was exactly our case. 
    I sent an email to the CA and a couple of days later we obtained our SRN. 
    I would advise you to do the same.


  • 15.  RE: Eudamed actor registrstion module

    Posted 12-May-2021 07:58
    I emailed the CA the same day as posting on this thread. Today, I received this update from the Ministry with this nice greeting :)

    "Dear Mrs. Roloff,

    Thank you for your registration in EUDAMED.

     The CIBG does all the validations for the Netherlands and will strive to complete the requests within 15 days. Because we are still in the starting phase it may take a bit longer. We have also had some national holidays this month. I expect you to hear soon about your request."

    So maybe that's some useful information for others who may be waiting on the Netherlands for the SRN.



    ------------------------------
    Timothy Roloff
    Sr. Regulatory / Quality Engineer
    NeoSoft LLC
    Pewaukee WI
    United States
    ------------------------------



  • 16.  RE: Eudamed actor registrstion module

    Posted 12-May-2021 03:51
    I registered in the actor registration module and within days contacted the CA (Portugal). They verified immediately and by the same day, we received the SRN. I found first the SRN in the database details of the company, we just received the email later on that day.

    ------------------------------
    Celia Cruz
    Complear
    Braga
    Portugal
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