Regulatory Open Forum

 View Only
  • 1.  Classification of sample receptacles under the IVDD (Europe)

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jan-2020 09:18
    This message was posted by a user wishing to remain anonymous

    Dear all,

    Happy new year!

    I wanted to know if a product is a "self-testing" IVD medical device (under the IVDD). The device is a receptacle for urine, intended to be used at home by the patient, the patients will deliver the samples to a specialist for the analysis. 

    Thank you very much in advance.



  • 2.  RE: Classification of sample receptacles under the IVDD (Europe)

    Posted 04-Jan-2020 06:20
    Hello,

    If you are talking about the EU IVDD - then it would be a General List.  Though even then it might just be considered an accessory - depends on what your "kit" looks like.

    If you are talking about the EU IVDR - then it would be Class A most likely as a specimen receptacle.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 3.  RE: Classification of sample receptacles under the IVDD (Europe)

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jan-2020 09:22
    This message was posted by a user wishing to remain anonymous

    Thank you very much @Richard Vincins

    A little description of the product:  ​It is a kit that collects urine in a sponge, then transfers the sample to a tube. The tube will be sent to a clinical lab in order to analyze the urine sample. 

    According to IVDD, does it count as a self-test? 

    Could you please briefly explain your rationale for that conclusion?

    Thanks a lot in advance!


  • 4.  RE: Classification of sample receptacles under the IVDD (Europe)

    Posted 06-Jan-2020 19:19

    First, start with the definitions.

    A device for self-testing means any device intended by the manufacturer to be able to be used by lay persons in a home environment.

    Specimen receptacles are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

    I think it is clear that the device you describe satisfies the definition of a specimen receptacle.

    I don't think it satisfies the definition of self-testing because the user doesn't get the result in the home environment, i.e., your device doesn't perform a test.

    Consider, as an example, a home use blood glucose test. It involves three devices. There is a lancet to draw blood, a test strip to collect the blood, and a glucometer that tests the blood and delivers the result. The result is produced in the home.

    By analogy, you have only one device. There is no equivalent to the lancet. The sponge and tube collect, hold, and preserve the sample. The instrument that analyses the sample and delivers the result is in the lab, not the home.

    I conclude that you have a specimen receptacle only.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------



  • 5.  RE: Classification of sample receptacles under the IVDD (Europe)

    Posted 07-Jan-2020 03:09
    Hi,

    A specimen receptacle is a self declared IVD under the IVDD, no doubts.


    ------------------------------
    Kees Maquelin, PhD, BSc
    Regulatory Affairs Manager Europe
    Netherlands
    ------------------------------



  • 6.  RE: Classification of sample receptacles under the IVDD (Europe)

    Posted 08-Jan-2020 09:50
    Dan answered well - this is most likely not considered a self-test device because this is being sent to a lab for testing.  A self-test device means the patient sees the result themselves, and more importantly interprets and reads the result themselves.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------