Regulatory Open Forum

Dear Colleagues,

according to your professional opinion, the hematological analysers (5-part WBC differential, laser and impedance based semi-automated hematology analyzer that provides a 27-parameter complete blood count report of anti-coagulated human whole blood samples) will be a Class C or B ? Based on rule 3 e, g and k,  I think it is Class C, as the test results are used for diagnosis/management of patients suffering from a life-threatening disease or condition (anaemia, low number of WBC and platelets). I have seen a NB opinion, that considered class B status for this device type.

I would appreciate to know your view.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Dear Peter,

According the MDCG 2020-16 (https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf), "If the instrument has an independent measuring function which does not use any additional reagents, it is classified according to the intended purpose of the analysis (including instruments controls or instrument quality control). e.g. cell counting analysers used in haematology, ..." and according the rule 2 for which the MDCG 2020-16 indicates "Devices intended for identifying markers, other than the red blood cell markers listed in this rule, which are either intended as screening, diagnostic, confirmatory or supplemental devices for blood grouping, tissue typing, or to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration are class C devices." Then I think you are right and your analyser is in class C.

Kind Regards

------------------------------
PASCALE
France
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Original Message:
Sent: 02-Aug-2021 09:46
From: Peter Miko
Subject: EU IVDR 2017/746/EC classification of hematological analysers

Dear Colleagues,

according to your professional opinion, the hematological analysers (5-part WBC differential, laser and impedance based semi-automated hematology analyzer that provides a 27-parameter complete blood count report of anti-coagulated human whole blood samples) will be a Class C or B ? Based on rule 3 e, g and k,  I think it is Class C, as the test results are used for diagnosis/management of patients suffering from a life-threatening disease or condition (anaemia, low number of WBC and platelets). I have seen a NB opinion, that considered class B status for this device type.

I would appreciate to know your view.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Hi Peter,

It is interesting that you have seen a NB opinion that a hematology analyzer is Class B. Perhaps the intended use of that device should be scrutinized. If it is indeed performing a complete blood count of the parameters you mentioned, this does not appear to align with the regulation or the MDCG 2020-16 guidance.

As you read through the classification rules outlined in IVDR, Annex VIII, one might initially believe that Rule 5(b) is appropriate for a hematology analyzer simply because it states the word "instruments": "instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures."

However, implementing rule 1.1 requires application of the classification rules to be governed by the device's intended purpose. Further, implementing rules 1.7 through 1.9 require the manufacturer to consider all implementing and classification rules that may apply to the device and to apply the higher classification rule where multiple rules apply.

Reading through the classification rules again considering the intended purpose of a hematology analyzer, Rule 3(j) appears to apply where the analyzer may be used to monitor levels of biological components (e.g., red cells, different white cells, platelets, etc.) when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient. This would mean that a hematology analyzer is a Class C device.

MDCG 2020-16 helps clarify this interpretation where on page 30 it states for Rule 3(j), "Analytes measured by devices intended for monitoring may be…biological components (pertaining to living organisms, or components of a living organism – this would include for example: antibodies, endogenous markers, platelets, cord blood, bone marrow, stem cells etc)." The guidance goes on to clarify that "Rule 3j is also applicable to the monitoring of non-life threatening conditions. It covers a wide range of analytes where the device provides an important, critical, or sole determinant for the correct patient management decision and an erroneous result may result in the life of the patient or patient's offspring being at risk due to inappropriate treatment decisions." Further, the examples listed for Rule 3(j) in MDCG 2020-16 include, "Devices intended for monitoring… Full blood count when used for monitoring for the development of a life threatening haematological disorder in patients being treated for other disorders/conditions."

I hope this helps inform your device classification.

Kind regards,

Christie

------------------------------
Christie Hughes MT(ASCP), MPH
Senior Consultant, Qserve Group
Austin, TX
United States
------------------------------

Original Message:
Sent: 02-Aug-2021 09:46
From: Peter Miko
Subject: EU IVDR 2017/746/EC classification of hematological analysers

Dear Colleagues,

according to your professional opinion, the hematological analysers (5-part WBC differential, laser and impedance based semi-automated hematology analyzer that provides a 27-parameter complete blood count report of anti-coagulated human whole blood samples) will be a Class C or B ? Based on rule 3 e, g and k,  I think it is Class C, as the test results are used for diagnosis/management of patients suffering from a life-threatening disease or condition (anaemia, low number of WBC and platelets). I have seen a NB opinion, that considered class B status for this device type.

I would appreciate to know your view.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Dear Colleagues,

I do appreciate your kind and professional opinions. Let me know if I may return your kindness.

with best regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 03-Aug-2021 10:19
From: Christie Hughes
Subject: EU IVDR 2017/746/EC classification of hematological analysers

Hi Peter,

It is interesting that you have seen a NB opinion that a hematology analyzer is Class B. Perhaps the intended use of that device should be scrutinized. If it is indeed performing a complete blood count of the parameters you mentioned, this does not appear to align with the regulation or the MDCG 2020-16 guidance.

As you read through the classification rules outlined in IVDR, Annex VIII, one might initially believe that Rule 5(b) is appropriate for a hematology analyzer simply because it states the word "instruments": "instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures."

However, implementing rule 1.1 requires application of the classification rules to be governed by the device's intended purpose. Further, implementing rules 1.7 through 1.9 require the manufacturer to consider all implementing and classification rules that may apply to the device and to apply the higher classification rule where multiple rules apply.

Reading through the classification rules again considering the intended purpose of a hematology analyzer, Rule 3(j) appears to apply where the analyzer may be used to monitor levels of biological components (e.g., red cells, different white cells, platelets, etc.) when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient. This would mean that a hematology analyzer is a Class C device.

MDCG 2020-16 helps clarify this interpretation where on page 30 it states for Rule 3(j), "Analytes measured by devices intended for monitoring may be…biological components (pertaining to living organisms, or components of a living organism – this would include for example: antibodies, endogenous markers, platelets, cord blood, bone marrow, stem cells etc)." The guidance goes on to clarify that "Rule 3j is also applicable to the monitoring of non-life threatening conditions. It covers a wide range of analytes where the device provides an important, critical, or sole determinant for the correct patient management decision and an erroneous result may result in the life of the patient or patient's offspring being at risk due to inappropriate treatment decisions." Further, the examples listed for Rule 3(j) in MDCG 2020-16 include, "Devices intended for monitoring… Full blood count when used for monitoring for the development of a life threatening haematological disorder in patients being treated for other disorders/conditions."

I hope this helps inform your device classification.

Kind regards,

Christie

------------------------------
Christie Hughes MT(ASCP), MPH
Senior Consultant, Qserve Group
Austin, TX
United States

Original Message:
Sent: 02-Aug-2021 09:46
From: Peter Miko
Subject: EU IVDR 2017/746/EC classification of hematological analysers

Dear Colleagues,

according to your professional opinion, the hematological analysers (5-part WBC differential, laser and impedance based semi-automated hematology analyzer that provides a 27-parameter complete blood count report of anti-coagulated human whole blood samples) will be a Class C or B ? Based on rule 3 e, g and k,  I think it is Class C, as the test results are used for diagnosis/management of patients suffering from a life-threatening disease or condition (anaemia, low number of WBC and platelets). I have seen a NB opinion, that considered class B status for this device type.

I would appreciate to know your view.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------