EU IVD HbA1c Regulation Classification

missjenny · Jul 25, 2014

Hello everyone!

According to Rule 4 of the new IVD Regulation, it seems pretty clear that POC BGMS (blood glucose monitoring system) would fall under class C. However, what of SMBG (self-monitoring of blood glucose or OTC)? It seems that because it is for self-testing, which the result is not determining a medically critical status, it should fall under class B, rather than C. I would highly appreciate your opinion on the matter. Also, would HbA1c also fall under class C?

Stijloor · Jul 29, 2014

A Quick Bump!

Can someone help?

Thank you very much!!

rangani_rj · Aug 26, 2014

Hi,

I was just searching for other thread and came here.......

From my medical background I can better realize the importance of glucose level in blood. It should be accurate up to the extent possible. Acute decrease (as a result of insulin overdose or false result) in blood glucose makes person faint or even dead because brain cant survive for more than few minutes without glucose (Hypoglycemic shock). Acute and average higher level of glucose may damage eye (permanent retinopathy), Kidneys and neurons. So glucose measurement should be accurate whether measured by general lab tests or self testing devices. HbA1c provides long term average value of glucose in blood and gives better idea about the future prognosis of diabetic symptoms, helps to better prescribe medicine.

pkost · Aug 26, 2014

Bearing in mind that this legislation is currently a proposal and is subject to change, the following is stated in Annex VII

Rule 4
(a) Devices intended for self-testing are classified as class C, except those devices
from which the result is not determining a medically critical status, or is
preliminary and requires follow-up with the appropriate laboratory test in
which case they are Class B.
(b) Devices intended for blood gases and blood glucose determinations for nearpatient
testing are class C. Other devices that are intended for near-patient
testing shall be classified in their own right.

for near patient testing, as you say, it is clear that blood sugar, including HbA1c is Class C. Self test is less clear, however:

for blood gluscose, I would argue that an incorrect reading could lead to the mismanagement of the disease which would have a a critical impact on the patient - DKA and hypoglycaemia being life threatening medical emergencies. While these can be treated with interventions, if it reaches this point it is unlikely that the patient will be able to take the necessary action themselves, which is the point of the self test. blood glucose self test should be therefore be Class C

For HbA1c self test (is there actually a need/call for this?) I would argue that the purpose of the reading is to give an indication of how blood glucose has been managed over an extended period of time, it has little to no immediate impact the the patients condiction therefore this would be Class B

rangani_rj · Aug 26, 2014

pkost said:
Bearing in mind that this legislation is currently a proposal and is subject to change, the following is stated in Annex VII

for near patient testing, as you say, it is clear that blood sugar, including HbA1c is Class C. Self test is less clear, however:

for blood gluscose, I would argue that an incorrect reading could lead to the mismanagement of the disease which would have a a critical impact on the patient - DKA and hypoglycaemia being life threatening medical emergencies. While these can be treated with interventions, if it reaches this point it is unlikely that the patient will be able to take the necessary action themselves, which is the point of the self test. blood glucose self test should be therefore be Class C

For HbA1c self test (is there actually a need/call for this?) I would argue that the purpose of the reading is to give an indication of how blood glucose has been managed over an extended period of time, it has little to no immediate impact the the patients condiction therefore this would be Class B

Thanks Pkost, this is good opinion and explanation. Yesterday, FDA just classified HbA1c test system to be class II (special control) and published in federal register.

https://www.gpo.gov/fdsys/pkg/FR-2014-08-25/html/2014-20022.htm

Special controls are also mentioned for this device.

EU IVD HbA1c Regulation Classification

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