See Full Document Text
Annexure A (Updated)
File No. IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
List of In-Vitro Diagnostic Medical Devices (IVD Analyzers)
under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017
Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
1 Clinical Alcohol body- A An analyzer (other than near-patient testing)
chemistry fluid analyser intended to determine the concentration of
alcohol in a body-fluid specimen. It is
intended for in-vitro diagnostic use.
C An analyzer intended to be used for near-
patient testing to determine the
concentration of alcohol in a body-fluid
specimen. It is intended for in-vitro
diagnostic use.
2 Amino acid A An analyzer intended to be used for the
analyser qualitative and/or quantitative in vitro
determination of individual amino acids in a
protein sample obtained from a clinical
specimen. It is intended for in-vitro
diagnostic use.
3 Bilirubinometry A A device (other than near-patient testing)
analyser that measures directly or indirectly the
bilirubin concentration in blood or other
samples. It is intended for in-vitro diagnostic
use.
C A device intended to be used for near-
patient testing that measure directly or
indirectly the bilirubin concentration in blood
or other samples. It is intended for in-vitro
diagnostic use.
4 Catecholamine A A device that measures catecholamine
s analyser concentration in biological samples. It is
intended for in-vitro diagnostic use.
Page 1 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
5 Clinical Chemilumines A An analyzer intended to be used for the
chemistry cent qualitative and/or quantitative in vitro
immunoassay determination of chemical and/or biological
analyser markers in a clinical specimen. It is intended
for in-vitro diagnostic use.
6 Chloride A An analyzer intended to be used for the
coulometric quantitative measurement of chloride in a
titration clinical specimen using a coulometric
analyser titration. It is intended for in-vitro diagnostic
use.
7 Cholesterol A A device that measures the cholesterol in
analyser serum/whole blood. It is intended for in-vitro
diagnostic use.
8 Clinical A An analyzer intended to be used for the
chemistry qualitative and/or quantitative determination
analyser of one or multiple clinical chemistry analytes
in a clinical specimen. It is intended for in-
vitro diagnostic use.
9 Creatinine A A device that measures creatinine
analyser concentration in urine or serum sample. It is
intended for in-vitro diagnostic use.
10 Enzyme A A device that measures the enzymatic
analyser activity of the sample for diagnosis. It is
intended for in-vitro diagnostic use.
11 Glycated A An analyzer intended to be used for the
haemoglobin quantitative measurement of glycated
(HbA1C) haemoglobin (HbA1c) in a clinical
analyser specimen. It is intended for in-vitro
diagnostic use.
12 High A An analyzer designed to use high
performance performance liquid chromatography (HPLC)
liquid for the qualitative and/or quantitative in vitro
chromatograph determination of chemical and/or biological
y analyser markers in a clinical specimen. It is intended
for in-vitro diagnostic use.
13 Identification A A device that identifies infectious/
and Antibiotic pathogenic microorganisms by photometry
susceptibility such as absorption, fluorescence and
analyser luminescence, and measures the
susceptibility to therapeutic drugs. It is
i ntended for in-vitro diagnostic use.
Page 2 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
14 Clinical Ion-selective A An analyzer intended to be used for the
chemistry analyser quantitative measurement of electrolytes
and/or other ions in a clinical specimen. It is
intended for in-vitro diagnostic use.
15 Lactate A An analyzer used to determine the
analyser concentration of lactate in various body
fluids using the lactate oxidase fixation
electrode. It is intended for in-vitro
diagnostic use.
16 Lipid profile A An analyzer intended to be used for the
analyser qualitative and/or quantitative in vitro
determination of lipid profile analytes in a
clinical specimen. It is intended for in-vitro
diagnostic use.
17 Nitrogen body- A An analyzer used to analyse the nitrogen
fluid-sample (N2) content in a body fluid. It is intended for
analyser in-vitro diagnostic use.
18 Protein A A device used to measure concentration
analyser and to identify specific proteins present in a
clinical specimen. It is intended for in-vitro
diagnostic use.
19 Radioimmunoa A An analyzer intended to be used for the
ssay analyser qualitative and/or quantitative in vitro
determination of chemical and/or biological
markers in a clinical specimen using an
immunological method which utilizes a
radiometric detection system to detect the
presence of immune complexes labelled
using a radioisotope. It is intended for in-
vitro diagnostic use.
20 Urine analyser A An analyzer (other than near-patient testing)
intended to be used for the qualitative
and/or quantitative in vitro determination of
various chemical and cellular constituents of
a clinical urine specimen. It is intended for
in-vitro diagnostic use.
C An analyzer intended to be used for near-
patient testing for the qualitative and/or
quantitative in vitro determination of various
chemical and cellular constituents of a
clinical urine specimen. It is intended for in-
vitro diagnostic use.
21 Clinical Biochemistry A An analyzer intended for measuring and
chemistry Analyzer analyzing various biologic and chemical
elements of human body fluid. It is intended
for in-vitro diagnostic use.
Page 3 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
22 Breath-alcohol A A device intended to measure alcohol in the
test system human breath. Measurements obtained by
this device are used in the diagnosis of
alcohol intoxication.
23 Nitric oxide B A device intended to measure fractional
breath nitric oxide in human breath. Measurement
analyzer of changes in fractional nitric oxide
concentration in expired breath aids in
evaluating an asthma patient's response to
anti-inflammatory therapy, as an adjunct to
establish clinical and laboratory
assessments of asthma. It is intended for in-
vitro diagnostic use.
24 Osmolality test A A device intended to measure ionic and
system non-ionic solute concentration in body
fluids, such as serum and urine. Osmolality
measurement is used as an adjunct to other
tests in the evaluation of a variety of
diseases, including kidney diseases (e.g.,
chronic progressive renal failure), diabetes
insipidus, other endocrine and metabolic
disorders, and fluid imbalances. It is
intended for in-vitro diagnostic use.
25 Osmometer A A device intended to measure the osmotic
pressure of body fluids. Measurements
obtained by this device are used in the
diagnosis and treatment of body fluid
disorders. It is intended for in-vitro
diagnostic use.
26 Plasma A A device intended to measure plasma
oncometer oncotic pressure, which is that portion of the
total plasma osmotic pressure contributed
by protein and other molecules too large to
pass through a specified semipermeable
membrane. Because variations in plasma
oncotic pressure are indications of certain
disorders, measurements of the variations
are useful in the diagnosis and treatment of
these disorders. It is intended for in-vitro
diagnostic use.
Page 4 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
27 Refractometer A A device intended to determine the amount
of solute in a solution by measuring the
index of refraction (the ratio of the velocity
of light in a vacuum to the velocity of light in
the solution). The index of refraction is used
to measure the concentration of certain
analytes (solutes), such a plasma total
proteins and urinary total solids.
Measurements obtained by this device are
used in the in-vitro diagnosis and treatment
of certain conditions.
28 Urea Breath A An analyzer intended for the use in the
Analyzer detection of urease (using breath sample)
associated with H. pylori in the human
stomach and is indicated as an aid in the
initial diagnosis of H. pylori infection. It is
intended for in-vitro diagnostic use.
29 Viscosimetric A A device that measures the resistance of
analyser fluid against the flow by intermolecular
force. It is also used for the analysis of
whole blood, serum or plasma. It is intended
for in-vitro diagnostic use.
30 Other Other Clinical A
Clinical chemistry
chemistry analyser
a nalyser (other than
near patient
testing)
31 Other Clinical C
chemistry
analyser
(intended to be
used near
patient testing)
32 H ematology ABO/Rh(D) A A lab based analyzer (other than near-
blood grouping patient testing) intended to be used to
analyser perform blood group testing to determine
the ABO and Rh(D) status of clinical
specimens. It is intended for in-vitro
diagnostic use.
D An analyzer (for near-patient testing)
intended to be used to perform blood group
testing to determine the ABO and Rh(D)
status of clinical specimens. It is intended
for in-vitro diagnostic use.
Page 5 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
33 Blood cell A A device that quantifies the formed
count analyser elements in the blood (i.e., erythrocytes,
leukocytes, and platelets) by electro
impedance, optical scattering or dye
binding. It is intended for in-vitro diagnostic
use.
34 Blood A An analyzer (other than near-patient
coagulation testing) intended to be used for the
analyser qualitative and/or quantitative in vitro
determination of one or multiple coagulation
components involved in haemostasis in a
clinical specimen. It is intended for in-vitro
diagnostic use.
C An analyzer intended to be used for near-
patient testing for the qualitative and/or
quantitative in vitro determination of one or
multiple coagulation components involved in
haemostasis in a clinical specimen. It is
intended for in-vitro diagnostic use.
35 Blood A An analyzer intended to be used to perform
group/antibody pre-transfusion blood group testing, red cell
screening antibody screening/identification and/or red
analyser cell phenotyping of clinical specimens or
donor specimens in order to determine
suitability for transfusion or transplantation.
It is intended for in-vitro diagnostic use.
36 Co-oximetry B An analyzer intended to be used for the
analyser quantitative in vitro measurement of oxygen
saturation, haemoglobin derivatives and
other calculated haemoximetry parameters
in a whole blood specimen. It is intended for
in-vitro diagnostic use.
37 Erthrocyte A An analyzer intended to be used to
sedimentation determine the erythrocyte sedimentation
rate (ESR) rate (ESR) of red blood cells in an
analyser anticoagulated whole blood specimen. It is
intended for in-vitro diagnostic use.
38 Flow cytometry A An analyzer intended to be used to count,
analyser examine and/or sort cells or microscopic
particles in a clinical specimen. It is
intended for in-vitro diagnostic use.
39 Heparin A A device that measures heparin
analyser concentration in blood samples. It is
intended for in-vitro diagnostic use.
Page 6 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
40 Osmotic A An analyzer intended to be used for the
fragility determination of the osmotic fragility of red
analyser blood cells in a whole blood specimen. It is
intended for in-vitro diagnostic use.
41 Reticulocyte A An analyzer intended to be used for the
analyser qualitative and/or quantitative in vitro
determination of reticulocytes, or immature
red blood cells in a clinical specimen. It is
intended for in-vitro diagnostic use.
42 Blood gas A An analyzer (other than near-patient testing)
analyser intended to be used for the quantitative in
vitro measurement of blood pH, partial
pressure of oxygen (pO2) and/or partial
pressure of carbon dioxide (pCO2), and the
calculation of other blood gas parameters in
a clinical specimen. It is intended for in-vitro
diagnostic use.
C An analyzer intended to be used for near-
patient testing for the quantitative in vitro
measurement of blood pH, partial pressure
of oxygen (pO2) and/or partial pressure of
carbon dioxide (pCO2), and the calculation
of other blood gas parameters in a clinical
specimen. It is intended for in-vitro
diagnostic use.
43 Haemoglobin A An analyzer intended to be used to
analyser determine the concentration of haemoglobin
in a clinical specimen. It is intended for in-
vitro diagnostic use.
44 Hematology A An analyzer intended to analyze in-vitro
Analyzer samples of whole blood to provide complete
blood count, leucocyte differential count,
classify and/or enumerate various
parameters using the impedance and
spectrophotometry techniques. It is intended
for in-vitro diagnostic use.
45 Thromboelastr A An analyzer intended to provide a
ogram (TEG) quantitative and/or qualitative indication of
Hemostasis the hemostasis state of a blood sample by
Analyzer monitoring, measuring, analyzing and
reporting hemostasis parameter information,
in order to assist in the assessment of
patient clinical hemostasis conditions. It is
intended for in-vitro diagnostic use.
Page 7 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
46 Platelet A An analyzer intended to be used for the
aggregation qualitative and/or quantitative in vitro
analyser examination of platelet function in a clinical
specimen, by inducing platelet aggregation
through the addition of platelet aggregating
agents. It is intended for in-vitro diagnostic
use.
47 Other Other A
hematology hematology
a nalyser analyser (other
than near
p atient testing)
48 Other C
hematology
analyser
(intended to be
used near
p atient testing)
49 Immunology Densitometry A An analyzer intended to be used for the
analyser qualitative and/or quantitative in vitro
determination of the staining pattern
intensity on film, acetate or other composite
medium to separate and/or visualize the
individual components of a clinical
specimen. It is intended for in-vitro
diagnostic use.
50 Enzyme A An analyzer intended to be used for the
immunoassay qualitative and/or quantitative in vitro
(EIA) analyser determination of chemical and/or biological
markers, in a clinical specimen, using an
immunological method. It is intended for in-
vitro diagnostic use.
51 Fluorescent A An analyzer intended to be used for the
immunoassay qualitative and/or quantitative in vitro
analyser determination of chemical and/or biological
markers in a clinical specimen. It is
intended for in-vitro diagnostic use.
Page 8 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
52 Immunology A An analyzer used to identify and detect the
analyzer concentration of specific substances in a
sample, using immunoassay
methodologies. It is intended for in-vitro
diagnostic use.
53 Immunofluores A A device used to measures the volume of
cent analyser antigen/antibody present in the components
of body fluids. It is intended for in-vitro
diagnostic use.
54 Microarray A An analyzer intended to be used for the in
analyser vitro determination of multiple target
analytes in a single clinical specimen using
oligonucleotide capture molecules arranged
in a consistent pattern on a slide, chip or
membrane. It is intended for in-vitro
diagnostic use.
55 I mmunology Particle- A A device for immunological measurement
counting by counting latex aggregates based on the
immunoassay light scattering. It is intended for in-vitro
analyser diagnostic use.
56 Photometric A An analyzer, intended to be used to scan an
immunoassay immunoassay reagent vehicle after
analyser exposure to a clinical specimen, to provide
a quantitative, semi-quantitative and/or
qualitative in vitro determination of chemical
substances and/or biological markers in a
clinical specimen, using photometry. It is
intended for in-vitro diagnostic use.
57 Microbiology Antimicrobial A An analyzer intended to be used for the in
susceptibility vitro determination of an antimicrobial
analyser susceptibility profile by monitoring the
growth rate of a microbiological organism
from a clinical specimen and/or culture
isolate when exposed to a range of
antimicrobials. It is intended for in-vitro
diagnostic use.
58 Blood culture A An analyzer intended to be used for the
analyser qualitative and/or quantitative in vitro
determination of microorganism growth in a
blood culture preparation or other clinical
specimen, with or without subsequent
identification of the organism. It is intended
for in-vitro diagnostic use.
Page 9 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
59 Gene analyser A A device that analyzes the sequence
information of nucleic acid molecules
extracted from biological samples. It is
intended for in-vitro diagnostic use.
60 Immunoturbidi A A light scattering analyzer that quantifies the
metric analytes in the body fluid by measuring the
analyser light scattering intensity from the immune
complex generated in the reaction between
analyte and antibody. It is intended for in-
vitro diagnostic use.
61 Microbiology Microorganism A An analyzer intended to be used for the
identification identification of bacteria and/or yeast
analyser isolated from clinical specimens by
characterizing their morphology, substrate
utilization and/or biochemical reactivity,
using growth detection technology. It is
intended for in-vitro diagnostic use.
62 Nucleic acid A An analyzer intended to amplify target
amplification deoxyribonucleic acid (DNA) or ribonucleic
(PCR) acid (RNA) in a clinical specimen. It is
analyser intended for in-vitro diagnostic use.
63 Yeast/fungi A An analyzer intended to be used for the
identification identification of yeast and/or fungi isolated
analyser from clinical specimens by characterizing
their morphology, substrate utilization
and/or biochemical reactivity, using growth
detection technology. . It is intended for in-
v itro diagnostic use.
64 Clinical Gas A An analyzer intended to be used for the
chemistry / chromatograph qualitative and/or quantitative in vitro
Microbiology y analyser determination of chemical and/or biological
/ Toxicology markers in a clinical specimen. It is intended
for in-vitro diagnostic use.
65 Clinical Mass A An analyzer intended to be used for the
chemistry / spectrometry qualitative and/or quantitative determination
Microbiology/ analyser of the chemical composition of a clinical
Hematology specimen by ionizing the specimen and
separating the resulting ions according to
mass using an electrical and magnetic field.
It is intended for in-vitro diagnostic use.
Page 10 of 11Sr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Part II,
Devices First
(IVD Schedule
Analyzers) of MDR
2017
66 Clinical Nephelometry A An analyzer intended to be used for the
chemistry / immunoassay qualitative and/or quantitative in vitro
Immunology analyser determination of chemical and/or biological
markers in a clinical specimen using an
immunological method which utilizes a
nephelometric detection system. It is
intended for in-vitro diagnostic use.
67 Gastroentero Faecal occult A An analyzer intended to be used for the
logy and blood qualitative and/or quantitative in vitro
Urology immunoassay determination of faecal occult blood, using
analyser an immunological method to detect or
measure haemoglobin in a clinical stool
(faeces) specimen. It is intended for in-vitro
diagnostic use.
68 Obstetrical Spermatozoa/s A An analyzer intended to be used for the
and emen analyser qualitative and/or quantitative in vitro
Gynecologic examination of a semen specimen to
al assess volume, spermatozoa concentration,
motility and/or morphological
characteristics. It is intended for in-vitro
diagnostic use.
69 Immunology Automated A A device that acquires, analyzes (results),
indirect stores, and displays digital images of
immunofluores indirect immunofluorescent slides. It is
cence intended to be used as an aid in the
microscope determination of antibody status in clinical
samples. It is intended for in-vitro diagnostic
use.
70 Immunology ELISA Plate A An analyzer intended for in vitro diagnostic
Reader use to measure radiant energy emitted,
transmitted, absorbed, or reflected under
controlled conditions and interpret ELISA
test results. It is intended for in-vitro
diagnostic use.
71 Microbiology Microscope A A device intended to enlarge images of
specimens, preparations and/or cultures (to
gain its physiological or morphological
information) for in-vitro diagnostic use.
72 Toxicology Lead test A A device intended to measure lead, a heavy
analyser metal, in blood and urine. Measurements
obtained by this device are used in the
diagnosis and treatment of lead poisoning. .
It is intended for in-vitro diagnostic use.
Page 11 of 11Annexure B (Updated)
File No. IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
List of In-Vitro Diagnostic Medical Devices (IVD Instruments)
under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017
Sr. Name of the Risk Class Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part II, First
(IVD Instruments) Schedule
of MDR
2017
1 Blood smear cassette A A device designed to be inserted into
an automated microscope slide
processing instrument to create a
blood smear on a microscope
examination slide for subsequent
staining and/or microscopic analysis.
It is intended to be used for an in vitro
diagnostic procedure.
2 Blood smear A A manual laboratory instrument
instrument intended to be used to create a blood
smear on a microscope examination
slide for subsequent staining and/or
microscopic analysis. It is intended to
be used for an in vitro diagnostic
procedure.
3 Blood tube mixer A An instrument intended to be used for
the mixing of blood or other biological
fluids contained in blood tubes or
other similar specimen receptacles
using continuous motion or agitation.
It is intended to be used for an in vitro
diagnostic procedure.
4 Blood component A A device designed for the separation
separator of whole blood or previously
centrifuged blood into components for
further processing or storage. It is
typically used for an in vitro diagnostic
procedure, and is not donor or patient
connected.
Page 1 of 6Sr. Name of the Risk Class Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part II, First
(IVD Instruments) Schedule
of MDR
2017
5 Cell washer A An instrument intended to be used to
separate red blood cells from whole
blood and wash the intact red blood
cells, to remove plasma, debris and/or
any other extraneous material so they
are free from interfering substances. It
is intended to be used for an in vitro
diagnostic procedure.
6 Colony counter A A device designed to count bacterial
coloniesin a culture. It is intended to
be used for an in vitro diagnostic
procedure.
7 Inoculating loop A A device intended to be used to
transfer and spread inoculum from a
clinical specimen and/or culture
isolate into a culture medium for
subsequent in vitro diagnostic
processing and/or testing.
8 Magnetic particle A An instrument intended to be used for
separation instrument the automated pre-analytical
extraction of specific molecules from a
clinical specimen using magnetic
particle separation techniques. It is
intended to be used for an in vitro
diagnostic procedure.
9 Microbial A A device intended to provide ideal
incubator/imaging conditions for microbial growth with an
system incubator, and to capture digital
images of the specimens contained
within the incubator at specified time
intervals. It is intended to be used for
an in vitro diagnostic procedure.
10 Microplate seal roller A A manually-operated device intended
to firmly apply a seal to a microplate.
It is intended to be used for an in vitro
diagnostic procedure.
Page 2 of 6Sr. Name of the Risk Class Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part II, First
(IVD Instruments) Schedule
of MDR
2017
11 Microplate washer A An instrument intended to be used for
washing microplates. It is intended to
be used for an in vitro diagnostic
procedure.
12 Microscope slide A An instrument intended to be used to
coverslipper apply a coverslip over a microscope
examination slide to protect the
fixed/stained specimen from
mechanical forces or environmental
exposure prior to microscopic
examination and/or long-term storage
of the slide. It is intended to be used
for an in vitro diagnostic procedure.
13 Microscope slide A An instrument intended to be used for
hybridization/ the incubation of microscope slides for
denaturation the denaturation and/or hybridization
incubator of a clinical specimen as part of an in
situ hybridization (ISH) and/or
fluorescence in situ hybridisation
(FISH) protocol. It is intended to be
used for an in vitro diagnostic
procedure.
14 Microscope slide A An instrument intended to be used to
maker/stainer prepare, transfer or fix blood, tissue or
other clinical specimens onto
microscope examination slides, and
then stain the slides using one or
more biological or cytochemical
staining solutions in preparation for
subsequent microscopic analysis. It is
intended to be used for an in vitro
diagnostic procedure.
15 Microscope slide A An instrument intended to be used for
washer washing microscope slides by
applying a flow of washing solution as
part of the processing steps required
to perform an in vitro diagnostic
assay. It is intended to be used for an
in vitro diagnostic procedure.
Page 3 of 6Sr. Name of the Risk Class Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part II, First
(IVD Instruments) Schedule
of MDR
2017
16 Nucleic acid sample A An instrument intended to be used for
preparation instrument the pre-analytical preparation of
samples for downstream nucleic acid
analysis. It is intended to be used for
an in vitro diagnostic procedure.
17 Slide-mounted-tissue A An assembly of devices designed to
dissection system be used for dissection of microscope-
slide-mounted tissue specimens
under digital image guidance, allowing
the user to digitally preselect the
target dissection area with high
precision. Excised tissues are
suctioned into a sample tube for
subsequent histopathology analysis. It
is intended to be used for an in vitro
diagnostic procedure.
18 Specimen processing A An instrument or platform intended to
instrument be used for the automated pre-
analytical preparation of a clinical
specimen (excluding specimens for
microbial culture), which may include
the sampling, diluting, and/or
aliquoting of clinical specimens and/or
any post-analytical processing
required, including labelling, storage
and/or location data. It is intended to
be used for an in vitro diagnostic
procedure.
19 Cell-freezing A A device used to freeze human red
apparatus blood cells. It is intended to be used
for an in vitro diagnostic procedure.
20 Centrifuge A An instrument intended to separate,
sediment, spin down aqueous
solutions and solvent suspensions of
differing densities in compatible
sample containers. It is intended to be
used for an in vitro diagnostic
procedure.
Page 4 of 6Sr. Name of the Risk Class Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part II, First
(IVD Instruments) Schedule
of MDR
2017
21 Cold plate A A device intended for chilling and
blocking out of histological tissue
samples in paraffin blocks. It is
intended to be used for an in vitro
diagnostic procedure.
22 Electrophoresis A An instrument intended to separate
apparatus molecules or particles, including
plasma proteins, lipoproteins,
enzymes, and hemoglobulins on the
basis of their net charge in specified
buffered media. This device is used in
conjunction with certain materials to
measure a variety of analytes as an
aid in the diagnosis and treatment of
certain disorders. It is intended to be
used for an in vitro diagnostic
procedure.
23 Hot plate A A device designed with heating plate
with high heat output and precise
temperature control, suitable for
flattening and drying cut histological
tissue specimens in molten paraffin. It
is intended to be used for an in vitro
diagnostic procedure.
24 Microscope glass A A device intended for mounting
slide Formalin Fixed Paraffin Embedded
(FFPE) tissue sections/ specimens,
suitable for cellular and tissue
specimen preparation for microscopic
analysis intended to be used for an in
vitro diagnostic procedure.
25 Paraffin Dispenser A Paraffin or Wax dispenser is an
instrument that melts the solid
paraffin, maintains it in its molten form
and dispenses it as and when
required. The dispenser is separately
heated to maintain the same
temperature as the paraffin reservoir.
It is used in Histopathology, Forensic
Medicine and Anatomy Lab, where
wax embedded moulds or blocks are
prepared for in vitro diagnostic
procedure.
Page 5 of 6Sr. Name of the Risk Class Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part II, First
(IVD Instruments) Schedule
of MDR
2017
26 Paraffin flotation bath A A device designed for use as a
heated, distilled water floating out
bath for the manipulation and location
of paraffin wax sections onto glass
slides, it is used for in vitro diagnostic
procedure.
27 Pipette/ Micropipette A An instrument designed and
constructed for accurate and precise
liquid handling, specifically intended
by the manufacturer to be used for in
vitro diagnostic
examinations/procedures. It is
intended to dispense liquid
(sample/specimen/buffer solutions) in
appropriate volume range in
combination with matching pipette
tips.
28 Tissue embedding A An instrument meant for embedding
system histological tissue specimens in
molten paraffin for use in pathology
laboratories. It is intended to be used
for an in vitro diagnostic procedure.
29 Any other instrument A
intended for
diagnostic purpose
Page 6 of 6Annexure C
File No. IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
List of In-Vitro Diagnostic Medical Devices (IVD Software)
under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017
Sr. Name of the Risk Intended use
No. In-Vitro Diagnostic Class as
Medical Devices per
(IVD Software) Part II,
First
Schedule
of MDR
2017
1 Cancer cell C A software program with specific image analysis
marker/morphology algorithms intended to be used in a digital pathology
image-analysis laboratory to assist in the analysis of
software immunohistochemically- or histologically-stained
clinical specimens for the quantitative detection of cell
markers or changes in tissue architecture and/or cell
morphological/physiological characteristics associated
with any type of cancer, performed during in vitro
diagnostic (IVD) testing.
2 Cancer risk C An interpretive software program intended to be used
assessment in the assessment of risk for developing cancer, by
interpretive software using IVD results of the qualitative and/or quantitative
detection of one or multiple cancer-specific biomarkers
in a clinical specimen.
3 Cardiovascular C An interpretive software program intended to be used
risk/probability in the assessment of risk/probability for having a
assessment cardiovascular condition or event, by using results of
interpretive software the qualitative/quantitative clinical specimen in vitro
diagnostic (IVD) tests.
4 Congenital C An interpretive software program intended to be used
defect/syndrome risk in the assessment of risk for the presence of a
assessment congenital medical defect and/or condition of a foetus.
interpretive software in vitro diagnostic (IVD) results of various
maternal/foetal biochemical, hormonal and/or
ultrasound markers.
Page 1 of 2Sr. Name of the Risk Intended use
No. In-Vitro Diagnostic Class as
Medical Devices per
(IVD Software) Part II,
First
Schedule
of MDR
2017
5 Human genomic C An interpretive software program intended to be used
analysis interpretive for the analysis and visualization of human genome
software data from in vitro diagnostic (IVD) results obtained
through molecular genetic testing. It provides predictive
and/or diagnostic information used in the assessment
of adverse health condition risk, disease prevention,
and/or health management.
6 Laboratory A A software program intended to be used with an in vitro
instrument/analyser diagnostic instrument/analyser or a data management
application software device connected to the IVD instrument/analyser, to
facilitate user-controlled device function.
7 Microbial A An application software program intended to be used
identification to identify microbial species (bacterial, fungal) using
interpretive software results from microbial cultures and laboratory
biochemical tests. Results from an in vitro diagnostic
medical device (IVD) are input and the name(s), and
reliability of possible microbial species returned. It is
intended for use in a microbiology laboratory.
8 Osteoporosis risk A An interpretive software program intended to be used
assessment in the assessment of risk for developing osteoporosis.
interpretive software This interpretive software program typically combines
patient demographics and the in vitro diagnostic (IVD)
results of the qualitative and/or quantitative detection of
one or multiple proteins in a tissue sample to establish
an individual risk score that may be used to guide
patient management.
Note:
Software, which drives a device or influences the use of a device, falls automatically
in the same class.
Software that is not incorporated in an in vitro diagnostic medical device shall be
classified using the classification provisions as specified in paragraph 2 of Part II of
First Schedule of Medical Devices Rules, 2017.
Page 2 of 2Annexure D (Added)
File No. IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle)
under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017
Sr. Name of the Risk Class Intended use
No. In-Vitro as per
Diagnostic Part II,
Medical Devices First
(IVD Instruments) Schedule
of MDR
2017
1 Blood Collection A A device, whether vacuum type or not,
Tube with/without coating (coating such as EDTA,
heparin, silicones, blood clot activators,
inhibitors, etc.), specifically intended by its
manufacturer for the primary containment of
predetermined volume of blood derived from
human or animal body, for the purpose of in
vitro diagnostic examinations.
2 Sample A A device specifically intended by its
containers manufacturer for the primary containment of
specimens derived from human or animal
body, for the purpose of in vitro diagnostic
examinations.
3 Arterial Blood A A device (sampler/syringe) for Blood Gas
Gas (ABG) Analysis (without needle) which is
preheparinized, electrolyte-balanced
Sampler
intended for the collection of arterial blood
samples and to connect with a Blood Gas
Analyzer for pH, blood gas, oximetry,
electrolyte and metabolite analysis. It is
intended for the purpose of in vitro diagnostic
examinations.
4 Microcuvette A A device intended for sample collection and
to measure appropriate volume of blood
(Capillary, venous and arterial whole blood)
directly from the skin surface by capillary
action. It is intended for the purpose of in
vitro diagnostic examinations.
Page 1 of 2Sr. Name of the Risk Class Intended use
No. In-Vitro as per
Diagnostic Part II,
Medical Devices First
(IVD Instruments) Schedule
of MDR
2017
5 Other Specimen A
Receptacles
(vacuum type or
not) without
needle used for
the collection of
Blood, Urine,
Stool, Sputum,
Semen, etc., for
purpose of
specimens
collection
intended for in-
vitro diagnostics
purpose.
Page 2 of 2Annexure E(Added)
File No. IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2)
rule 4 of the Medical Devices Rules, 2017
Sr. Category Name of the In- Risk class Intended use
No. Vitro Diagnostic as per Part
Medical Devices –II First
Schedule
of MDR
2017
1. COVID-19 IVD Rapid/ELISA/CLIA C Used for In-Vitro
(Serology based) diagnosis of covid-19
RT-PCR/LAMP C Used for In-Vitro
(Molecular Based) diagnosis of covid-19
Antigen Test C Used for In-Vitro
diagnosis of covid-19
Antigen Home test C Used for In-Vitro
diagnosis of covid-19
2. RNA extraction Ribonucleic acid C Ribonucleic acid
kits (RNA) Extraction (RNA) Extraction Kits
Kits intended for
specimen derived
from human or
animal body for In-
Vitro diagnostics
purpose.
3. DNA extraction Deoxyribonucleic C Deoxyribonucleic
kits acid (DNA) acid (DNA)
Extraction Kits Extraction Kits
intended for
Page 1 of 2specimen derived
from human or
animal body for In-
Vitro diagnostics
purpose.
4. Viral Transport Viral Transport A Viral Transport
Medium (VTM) Medium (VTM) Medium (VTM) for
specimen derived
from Human or
animal body intended
for In-Vitro
Diagnosis.
5 Reagents/kits Sickle Cell IVD C Used for In-Vitro
for detection diagnosis of Sickle
markers for Cell
congenital
disorders
Page 2 of 2