Market Authorization of In-vitro Diagnostic Devices in
EU
Definition of
In-vitro Diagnostic Devices (IVDs):
According to the Directive (98/97/EC), in-vitro
diagnostic medical device means any medical device which is a reagent, reagent
product, calibrator, control material, kit, instrument, apparatus, equipment,
or system, whether used alone or in combination, intended by the manufacturer
to be used in vitro for the examination of specimens, including blood and
tissue donations, derived from the human body, solely or principally for the
purpose of providing information:
i. concerning a physiological or pathological state, or
ii. concerning a congenital abnormality, or
iii. to determine the safety and compatibility with
potential recipients, or
iv. to monitor therapeutic measures [1].
Classification of IVDs:
|
Class A (Low Risk) |
Class B (Moderate Risk) |
Class C (Moderate to High
Risk) |
Class D (High Risk) |
|
General IVDs excluding those for self-testing and IVDs listed in Annex
II of Directive 98/97/EC. |
IVDs for self-testing excluding
those listed in Annex II of Directive 98/97/EC. |
IVD medical devices in List B of
Annex II of Directive 98/97/EC: i. Reagents
and reagent products, including related calibrators and control materials,
for determining the following blood groups: anti-Duffy and anti-Kidd; ii. Reagents
and reagent products, including related calibrators and control materials,
for determining irregular anti-erythrocytic antibodies; iii. Reagents
and reagent products, including related calibrators and control materials,
for the detection and quantification in human samples of the following
congenital infections: rubella, toxoplasmosis, iv. Reagents
and reagent products, including related calibrators and control materials,
for diagnosing the following hereditary disease: phenylketonuria; v. Reagents
and reagent products, including related calibrators and control materials,
for determining the following human infections: cytomegalovirus, chlamydia; vi. Reagents
and reagent products, including related calibrators and control materials,
for determining the following HLA tissue groups: DR, A, B; vii. Reagents
and reagent products, including related calibrators and control materials,
for determining the following tumoral marker: PSA; viii. Reagents
and reagent products, including related calibrators, control materials and
software, designed specifically for evaluating the risk of trisomy 21; ix. The
following device for self-diagnosis, including its related calibrators and
control materials: device for the measurement of blood sugar. |
IVD medical devices in List A of
Annex II of Directive 98/97/EC: i. Reagents
and reagent products, including related calibrators and control materials,
for determining the following blood groups: ABO system, rhesus (C, c, D, E,
e) anti-Kell; ii. Reagents
and reagent products, including related calibrators and control materials,
for the detection, confirmation and quantification in human specimens of
markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and
D. |
Regulatory Pathway
for IVDs:
1. Class A
2. Class B
3. Class C
4. Class D
References:
