Module 18 2021

06/02/2021

Blood glucose monitoring devices are intended for the quantitative measurement of blood glucose levels in freshly collected capillary blood samples. Such monitors provide immediate information to the user on whether the blood sugar is too high (hyperglycaemia) or too low (hypoglycaemia). In cases of hyperglycaemia, the test result is then used to calculate an adequate insulin dosage to be administered to the patient Devices that are intended to be used for monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be CDxs

⇨ Annex VIII, rule 3 (k), class C: Devices intended for management of patients suffering from a life-threatening disease or condition. Example from the Medical Device Coordination Group (MDCG) classification guidance: HbA1c and blood glucose tests for the management of patients with diabetes

What are NOT companion diagnostics ? Example No 1

The Organisation for Professionals in Regulatory Affairs

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Cyclosporine, Sirolimus, Tacrolimus as Therapeutic Drug Monitoring Devices (TDM ) to measure cyclosporine, sirolimus or tacrolimus blood concentrations to enable the dose of the drug individualized to the patient to improved transplant outcome for transplants of liver, kidney, heart, pancreas, lung, and intestines, and for prevention of graft-versus-host disease

Annex VIII, Rule 3 (j), class c: Devices intended for monitoring of levels of medicinal products, substances or biological components, 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 or for the patient's offspring

Example from the MDCG classification guidance: Devices intended for monitoring of iimmunosuppressive (anti-rejection) medicinal products e.g. cyclosporine, sirolimus, tacrolimus

What are NOT companion diagnostics ? Example No 2

The Organisation for Professionals in Regulatory Affairs

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