**Executive Summary:**
This notice from the Drugs Controller General of India classifies In-Vitro Diagnostic (IVD) Medical Devices under the Medical Devices Rules, 2017. It aims to regulate the safety, quality, and performance of IVDs. The classification is based on intended use, risk, and other parameters as specified in the First Schedule of the Medical Devices Rules, 2017 and is effective as of July 23, 2021.
**Key Points / Main Content:**
* **Regulatory Framework:**
* The Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, regulate the safety, quality, and performance of Medical Devices and In-Vitro Diagnostic Medical Devices.
* The Medical Devices Rules, 2017 were implemented from January 1, 2018.
* **Classification of IVDs:**
* The Drugs Controller General of India classifies IVDs based on intended use, risk associated with the device, and parameters in the First Schedule of the Medical Devices Rules, 2017, under subrule 3 of rule 4.
* Lists of classified IVDs are provided in Annexure A (IVD Analyzers), Annexure B (IVD Instruments), and Annexure C (IVD Software).
* **Guidance and Revisions:**
* The classification list is intended as guidance for applicants importing or manufacturing medical devices under the Medical Devices Rules, 2017.
* The classification list is dynamic and subject to revision under the Medical Devices Rules, 2017.
**Impact Analysis**
**Applicants for Import or Manufacture of Medical Devices:**
* Impact:
* Need to understand the classification of their specific IVD devices according to Annexure A, B, and C to comply with the Medical Devices Rules, 2017.
* Action Required:
* Review Annexure A, B and C to determine the correct classification for their IVD devices.
* Ensure applications for import or manufacture align with the classifications in the provided lists.
**CDSCO (Central Drugs Standard Control Organisation) Website Users:**
* Impact:
* The classification list is available on the CDSCO website for reference.
* Action Required:
* Consult the CDSCO website for the most up-to-date classification list, as it is subject to revisions.
Key Entities Referenced
Drugs Controller General India: Regulatory authority responsible for medical devices and pharmaceuticals.
Directorate General of Health Services: A government organization associated with health services.
Medical Devices Rules, 2017: The regulatory framework governing medical devices in India.
Drugs and Cosmetics Act, 1940: The primary legislation governing drugs and cosmetics in India, under which medical devices are also regulated.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government on matters related to drug regulation.
InVitro Diagnostic Medical Devices: Medical devices used for in vitro diagnostics, regulated under the Medical Devices Rules, 2017.
Central Government: The governing body responsible for implementing the Medical Devices Rules, 2017.
New Delhi: The location of the Drugs Controller General India office in India.
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
NOTICE
File No. |VD/Misc/196/2020 Date: 49 3 JUL 2021
Subject: Classification of In-vitro Diagnostic Medical Devices under the
provisions of Medical Devices Rules, 2017 - Regarding.
Safety, quality and performance of Medical Devices and /n-vitro Diagnostic
Medical Devices are regulated under the provisions of the Drugs and Cosmetics Act,
1940 and rules, made there under. For the regulation of Medical Devices and /n-vitro
Diagnostic Medical Devices with respect to the import, manufacture, clinical
investigation, clinical performance evaluation, sale and distribution, the Central
Government, after consultation with the Drugs Technical Advisory Board, has notified
Medical Devices Rules, 2017 vide G.S.R. 78(E) dated 31.01.2017 which is already
implemented from 01.01.2018.
In this connection, in exercise of the powers conferred under sub-rule (3) of
rule 4 of Medical Devices Rules, 2017, the undersigned hereby classifies the In-vitro
Diagnostic Medical Devices based on the intended use, risk associated with the device
and other parameters specified in the First Schedule.
List of In-vitro Diagnostics Medical Devices placed at Annexure A, Annexure B
and Anne 1.x u Gr ee n C er ais l s u ib nj te ec nt de ed d t uo s t eh e g if vo el nlo w ai gn ag is n: st each of the device is for guidance to
the applicants who intends to furnish application of import or manufacture
of medical Devices under the provisions of Medical Devices Rules, 2017.
However, as device may have specified intended use as specified by its
2. Tm ha in su f la isc tt u isr e dr y. namic and is subjected to revision from time to time under the
provisions of the Medical Devices Rules, 2017.
w
(Dr. V.G. Somani)
Drugs Controller General of India
To,
CDSCO WebsiteAnnexure A
File No. IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
Date: 2 3 JUL 2021
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 Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
1 | Clinical Alcohol body-fluid A An analyzer intended to determine the
chemistry analyser
concentration of alcohol in a body-
fluid specimen.
Cc An analyzer intended to be used for
near-patient testing to determine the
concentration of alcohol in a body-
fluid specimen.
2 Amino acid A An analyzer intended to be used for
analyser
the qualitative and/or quantitative in
vitro determination of individual amino
acids in a protein sample obtained
from a clinical specimen.
3
Bilirubinometry A A device that measures directly or
analyser
indirectly the bilirubin concentration in
blood or other samples.
Cc A device intended to be used for near-
patient testing that measure directly or
indirectly the bilirubin concentration in
blood or other samples.
4
Catecholamines A A device that measures
analyser
catecholamine concentration in
biological samples.
5 | Chemiluminescent A An analyzer intended to be used for
immunoassay the qualitative and/or quantitative in
analyser
vitro determination of chemical and/or
biological markers in a clinical
specimen.
Page 1 of 8(Gr. | Category Name of the Risk Intended use
No.
In-Vitro Class as
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
6 | Clinical Chloride A An analyzer intended to be used for
chemistry coulometric titration the quantitative measurement of
analyser
chloride in a clinical specimen using a
coulometric titration.
7 Cholesterol A A device that measures the
analyser
cholesterol in serum/whole blood.
8 Clinical chemistry A An analyzer intended to be used for
analyser
the qualitative and/or quantitative
determination of one or multiple
clinical chemistry analytes in a clinical
specimen.
9 Creatinine analyser A A device that measures creatinine
concentration in urine or serum
sample.
10 Enzyme analyser A A device that measures the enzymatic
activity of the sample for diagnosis.
11 Glycated A An analyzer intended to be used for
haemoglobin the quantitative measurement of
(HbA1C) analyser glycated haemoglobin (HbA1c) ina
clinical specimen.
12 High performance A An analyzer designed to use high
liquid
performance liquid chromatography
chromatography (HPLC) for the qualitative and/or
analyser
quantitative in vitro determination of
chemical and/or biological markers in
a clinical specimen.
13 Identification and A A device that identifies
Antibiotic
infectious/pathogenic microorganisms
susceptibility by photometry such as absorption,
analyser
fluorescence and luminescence, and
measures the susceptibility to
therapeutic drugs.
14
lon-selective A An analyzer intended to be used for
analyser
the quantitative measurement of
electrolytes and/or other ions in a
clinical specimen.
15 Lactate analyser A An analyzer used to determine the
concentration of lactate in various
body fluids using the lactate oxidase
fixation electrode.
Page 2 of 8or. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
16 Clinical Lipid profile A An analyzer intended to be used for
chemistry analyser the qualitative and/or quantitative in
vitro determination of lipid profile
analytes in a clinical specimen.
17 Nitrogen body- An analyzer used to analyse the
fluid-sample nitrogen (N2) content in a body fluid.
analyser
18 Protein analyser A device used to measure
concentration and to identify specific
proteins present in a clinical
specimen.
19 Radioimmunoassa An analyzer intended to be used for
y analyser the 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.
20 Urine analyser An analyzer intended to be used for
the qualitative and/or quantitative in
vitro determination of various
chemical and cellular constituents of a
clinical urine specimen.
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.
21 Hematology ABO/Rh(D) blood A lab based analyzer (other than
grouping analyser near-patient testing) intended to be
used to perform blood group testing to
determine the ABO and Rh(D) status
of clinical specimens.
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.
Page 3 of 8Intended use
Sr. | Category Name of the Risk
In-Vitro Class as
No.
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
A device that quantifies the formed
22 | Hematology Blood cell count A elements in the blood (i. e. ,
analyser erythrocytes, leukocytes, and
platelets) by electroimpedance, optical
scattering or dye binding.
An analyzer intended to be used for
23 Blood coagulation the qualitative and/or quantitative in
analyser vitro determination of one or multiple
coagulation components involved in
haemostasis in a clinical specimen.
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.
An analyzer intended to be used to
24 Blood perform pre-transfusion blood group
group/antibody
testing, red cell antibody
screening analyser screening/identification and/or red cell
phenotyping of clinical specimens or
donor specimens in order to
determine suitability for transfusion or
transplantation.
An analyzer intended to be used for
25 Co-oximetry the quantitative in vitro measurement
analyser of oxygen saturation, haemoglobin
derivatives and other calculated
haemoximetry parameters in a whole
blood specimen.
An analyzer intended to be used to
26
Erthrocyte
determine the erythrocyte
sedimentation rate sedimentation rate (ESR) of red blood
(ESR) analyser cells in an anticoagulated whole blood
specimen.
An analyzer intended to be used to
27 Flow cytometry count, examine and/or sort cells or
analyser microscopic particles in a clinical
specimen.
A device that measures heparin
28 Heparin analyser concentration in blood samples.
Page 4 of 8( 3r. | Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
29 | Hematology | Osmotic fragility A An analyzer intended to be used for
analyser the determination of the osmotic
fragility of red blood cells in a whole
blood specimen.
30 Reticulocyte A An analyzer intended to be used for
analyser the qualitative and/or quantitative in
vitro determination of reticulocytes, or
immature red blood cells in a clinical
specimen.
31 Blood gas analyser A An analyzer 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.
Cc 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.
32 Haemoglobin A An analyzer intended to be used to
analyser determine the concentration of
haemoglobin in a clinical specimen.
33 Platelet A An analyzer intended to be used for
aggregation the qualitative and/or quantitative in
analyser vitro examination of platelet function in
a clinical specimen, by inducing
platelet aggregation through the
addition of platelet aggregating
agents.
34 | Immunology | Densitometry A An analyzer intended to be used for
analyser the 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.
Page 5 of 8(Sr. | Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
35 | Immunology | Enzyme A An analyzer intended to be used for
immunoassay the qualitative and/or quantitative in
(EIA) analyser vitro determination of chemical and/or
biological markers, in a clinical
specimen, using an immunological
method.
36 Fluorescent A An analyzer intended to be used for
immunoassay the qualitative and/or quantitative in
analyser vitro determination of chemical and/or
biological markers in a clinical
specimen.
37 Immunology A An analyzer used to identify and
analyzer detect the concentration of specific
substances in a sample, using
immunoassay methodologies.
38 Immunofluorescent A A device used to measures the
analyser volume of antigen/antibody present in
the components of body fluids.
39 Microarray A An analyzer intended to be used for
analyser the in 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.
40 Particle-counting A A device for immunological
immunoassay measurement by counting latex
analyser aggregates based on the light
scattering.
41 Photometric A An analyzer, intended to be used to
immunoassay scan an immunoassay reagent vehicle
analyser after 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.
Page 6 of 8(Sr. | Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
42 | Microbiolog | Antimicrobial A An analyzer intended to be used for
y susceptibility the in vitro determination of an
analyser antimicrobial 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.
43 Blood culture A An analyzer intended to be used for
analyser the 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.
44 Gene analyser A A device that analyzes the sequence
information of nucleic acid molecules
extracted from biological samples.
45 Immunoturbidimetri A A light scattering analyzer that
c analyser quantifies the analytes in the body
fluid by measuring the light scattering
intensity from the immune complex
generated in the reaction between
analyte and antibody.
46 Microorganism A An analyzer intended to be used for
identification the identification of bacteria and/or
analyser yeast isolated from clinical specimens
by characterizing their morphology,
substrate utilization and/or
biochemical reactivity, using growth
detection technology.
47 Nucleic acid A An analyzer intended to amplify target
amplification (PCR) deoxyribonucleic acid (DNA) or
analyser ribonucleic acid (RNA) in a clinical
specimen.
48 Yeast/fungi A An analyzer intended to be used for
identification the identification of yeast and/or fungi
analyser isolated from clinical specimens by
characterizing their morphology,
substrate utilization and/or
biochemical reactivity, using growth
detection technology.
Page 7 of 8Osr. Category Name of the Risk Intended use
No. In-Vitro Class as
Diagnostic per
Medical Devices Part Il,
(IVD Analyzers) First
Schedule
of MDR
2017
Other In-Vitro Diagnostic Medical Devices (IVD Analyzers)
49 | Clinical Gas A An analyzer intended to be used for
chemistry / chromatography the qualitative and/or quantitative in
Microbiology | analyser vitro determination of chemical and/or
/ Toxicology biological markers in a clinical
specimen.
50 | Clinical Mass spectrometry A An analyzer intended to be used for
chemistry / analyser the qualitative and/or quantitative
Microbiology/ determination of the chemical
Hematology composition of a clinical specimen by
ionizing the specimen and separating
the resulting ions according to mass
using an electrical and magnetic field.
51 | Clinical Nephelometry A An analyzer intended to be used for
chemistry / immunoassay the qualitative and/or quantitative in
Immunology | analyser vitro determination of chemical and/or
biological markers in a clinical
specimen using an immunological
method which utilizes a nephelometric
detection system.
52 | Gastroentero | Faecal occult blood A An analyzer intended to be used for
logy and immunoassay the qualitative and/or quantitative in
Urology analyser vitro determination of faecal occult
blood, using an immunological
method to detect or measure
haemoglobin in a clinical stool
(faeces) specimen.
53 | Obstetrical Spermatozoa/seme A An analyzer intended to be used for
and n analyser the qualitative and/or quantitative in
Gynecologic vitro examination of a semen
al specimen to assess volume,
spermatozoa concentration, motility
and/or morphological characteristics.
Page 8 of 8Annexure B
File No.
IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
Date: {2 3 JUL 2021
List of In-Vitro Diagnostic Medical Devices (IVD Instuments)
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 Il,
(IVD Instruments) First
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.
2 | Blood smear instrument A A manual laboratory instrument
intended to be used to create a blood
smear on a microscope examination
slide for subsequent staining and/or
microscopic analysis.
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.
4 | Blood com ponent A A wh d oe lv ei c be l od oe ds i org n pe rd e vf io or u t sh le y s cee np ta rr ia ft ui go en d of
separator
blood into components for further
processing or storage. It is typically
used in a blood bank or transfusion
centre, and is not donor or patient
connected.
5 | Blood Collection Tube A A device, whether vacuum type or not,
specifically intended for the primary
containment of predetermined volume
of blood derived from human or animal
body.
Page 1 of 3) Sr. Name of the Risk Class
Intended use
No. In-Vitro Diagnostic as per
Medical Devices Part Il,
(IVD Instruments) First
Schedule
of MDR
20 A1 7 An instrument intended to be used to
| 6 | Cell washer
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
and suitable for use in subsequent in
7 | Colony counter A
Avi t dr eo vc il cin ei c da el st ie gst ni en dg .
to count bacterial
colonies in a culture.
8 | 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.
9 | Magnetic particle A A thn e i an us tt or mu ame tn et d i pn rt ee -n ad nae ld y tt io c b ale eu xs te rad c tfo ir on
separation instrument
of specific molecules from a clinical
specimen using magnetic particle
separation techniques.
A A device intended to provide ideal
10 | Microbial conditions for microbial growth with an
incubat or/imaging
incubator, and to capture digital
system
images of the specimens contained
within the incubator at specified time
intervals.
41 | Microplate seal roller A A
manually-operated device intended
to firmly apply a seal to a microplate.
12 | Microplate washer A An instrument intended to be used for
washing microplates.
13 | Microscope slide A An instrument intended to be used to
apply a coverslip over a microscope
coverslipper 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.
Page 2 of 3Sr. Name of the Risk Class Intended use
(an
No. In-Vitro Diagnostic as per
Medical Devices Part Il,
(IVD Instruments) First
Schedule
of MDR
2017
14 | Microscope slide A An instrument intended to be used for
hybridization/ the incubation of microscope slides for
denaturation incubator the denaturation and/or hybridization of
a Clinical specimen as part of an in situ
hybridization (ISH) and/or fluorescence
in situ hybridisation (FISH) protocol.
15 | 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.
16 | Microscope slide A An instrument intended to be used for
washing microscope slides by applying
washer
a flow of washing solution as part of
the processing steps required to
perform an in vitro diagnostic assay.
17 | Nucleic acid sample A An instrument intended to be used for
preparation instrument the pre-analytical preparation of
samples for downstream nucleic acid
analysis.
18 | Slide-mounted-tissue A An assembly of devices designed to be
dissection system 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.
A An instrument or platform intended to
19
Specimen processing
be used for the automated pre-
instrument
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.
Page 3 of 3Annexure C
File No.
IVD/Misc/196/2020
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
Date: 2 3 JUL 2021
List of In-Vitro Diagnostic Medical Devices (IVD Software)
under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017
Intended use
Sr. Name of the Risk
No. | In-Vitro Diagnostic | Class as
Medical Devices per
(IVD Software) Part Il,
First
Schedule
of MDR
1 Cancer cell
20Cc1 7 A software program with specific image analysis
marker/morphology
algorithms intended to be used in a digital pathology
image-an alysis l ia mb mo ur na ot ho ir sy t t oo c has es mi is ct a lin l yt -h e o ra n ha il sy ts oi ls o go if cally-stained
software
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 Cc An interpretive software program intended to be used
a ins ts ee rps rs em tie vn et s oftware
uin
s
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o
fo f
t
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q
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i
td ae tv ie vl
e
o ap ni dn /g
o
rc a qn uc ae nr t,
i
tb aty
ive
detection of one or multiple cancer-specific biomarkers
in a clinical specimen.
3 Cardiovascular Cc An interpretive software program intended to be used
risk/probabili ty cin a rt dh ie o va as ss ce us ls am r e cn ot n do if t ir oi nsk o/p rr eob va eb ni tl ,i t by y f o ur s ih na gv i rn eg s ua lts of
a ins ts ee rps rs em tie vn et software the qualitative/quantitative clinical specimen in vitro
diagnostic (IVD) tests.
4 Congenital Cc An interpretive software program intended to be used
defect/synd rome risk cin o nt gh ee n ia ts as le s mes dm ie cn at l o df e r fi es ck t f aor n dt /h oe r p cr oe ns de itn ic oe n o of f a a foetus.
assessment
interpretive software in vitro diagnostic (IVD) results of various
maternal/foetal biochemical, hormonal and/or
ultrasound markers.
Page 1 of 2o Sr. Name of the Risk
Intended use
No. In-Vitro Diagnostic Class as
Medical Devices per
(IVD Software) Part Il,
First
Schedule
of MDR
2017
An interpretive software program intended to be used
Human genomic Cc
analysis interpretive
for the analysis and visualization of human genome
data from in vitro diagnostic (IVD) results obtained
software 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.
A software program intended to be used with an in vitro
Laboratory diagnostic instrument/analyser or a data management
instrument/analyser
device connected to the IVD instrument/analyser, to
application software
facilitate user-controlled device function.
An application software program intended to be used
Microbial to identify microbial species (bacterial, fungal) using
identification
results from microbial cultures and laboratory
interpretive software
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.
An interpretive software program intended to be used
Osteoporosis risk
in the assessment of risk for developing osteoporosis.
assessment This interpretive software program typically combines
interpretive software
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 Il of
First Schedule of Medical Devices Rules, 2017.
Page 2 of 2