A medical device is an appliance software material, or other article whether used alone or in combination

1. UNIT -1 (MRA 201T)
MEDICAL DEVICES AND IVD’S
Presented by:
Ms.Bhanu Mounika
Reg. No.: 222310
I. M. Pharmacy
Shri Vishnu College of Pharmacy
Under the Guidance of:
Dr. Lakshmi Prasanthi Nori
Professor
Department of Regulatory Affairs

2. DEFINITION:
As per CDSCO,
A medical device is an apparatus, appliance,
software material, or other article whether
used alone or in combination, including the
software intended by its manufacturer to be
used specifically for diagnostic or
therapeutic purposes and necessary for its
proper application.
Medical Devices

3. As Per US FDA
1. An instrument, apparatus, implement, machine, implant, reagent, or
other similar or related article, including a component part or
accessory which is recognized in the official National Formulary, or
the United States Pharmacopoeia, or any supplement .
2. Intended for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease, in man or
other animals.

4. Risk Based Classification In Accordance To CDSCO
CLASS RISK LEVEL EXAMPLES
A Low Bandages , Tongue depressors
B Low - Moderate Hypodermic Needles , suction equipment
C Moderate - High Lung ventilator , Bone fixation plate
D High Heart valves , Implantable defibrillator

5. CLASS RISK LEVEL EXAMPLE
I Low Bandages , tongue depressors
II Moderate Nebulizers
III High Pacemakers , Intra ocular lenses
Risk Based Classification in Accordance to
USFDA

6. Risk Based Classification in Accordance to EU
CLASS RISK LEVEL EXAMPLE
I Low Surgical Guaze, Wheelchairs
IIa Moderate Hearing aids, Ultrasound equipment
IIb Potential high risk Infusion pumps, Surgical Lasers
III High risk Stunt-grafts, Prosthetic joints

7. IN VITRO DIAGNOSTIC DEVICES
DEFINITION:
As per CDSCO,
1. A device intended by the manufacturer
for the In-vitro examination of specimens
derived from the human body solely or
principally to provide information for
diagnosis, monitoring or compatibility
purposes.
2. This includes reagents, calibrators,
control materials, specimen receptacles,
software, and related instruments

8. In simple words, IVDs are medical devices used to perform
tests on samples, such as blood, urine, tissue is taken away
from the human body to help detect infection, diagnose a
medical condition, prevent disease.
Some examples of IVDs include systems to test the
1)level of coagulation,
2) urine test strips,
3)Home use pregnancy tests,
4)HIV or Hepatitis tests,
5)Blood glucose monitoring, etc.

9. Risk Based Classification In Accordance To CDSCO
CLASS RISK LEVEL IVD’s Examples
A Low Clinical Chemistry Analyzer, Prepared
selective culture media
B Low – Moderate Pregnancy self testing, Urine test strips
C Moderate – High Blood glucose self testing, Rubella
testing equipment
D High HIV blood donor screening, HIV Blood
test

10. USFDA
Class Risk level
Regulatory
requirements
Examples
I Low risk General controls
Stethoscopes
II Moderate risk
General controls ,
special controls
Syringe , MRI scanner
III High risk
General controls ,
PMA
Neuromuscular
stimulator

11. CLASS RISK LEVEL IVD’s Examples
A Low Individual Risk and
Low Public Health Risk
Clinical Chemistry Analyzers,
Specimen receptacles
B Moderate Individual Risk
and Low Public Health
Risk
Vitamin B12,Pregnancy Self Testing,
Urine test strips
C High Individual Risk and
Moderate Public Health
Risk
Blood Glucose Self Testing, PSA
Screening
D High Individual Risk and
High Public Health Risk
HIV Blood Diagnostic, HIV blood
donor
EU

12. Essential Principles of
Medical Devices and Ivd’s
 The device when used for specified conditions, by experienced persons,
it should perform as intended without compromising the health and
safety of the patients.
 Manufacturers should adopt solutions to identify and reduce risks as far
as possible during designing and manufacturing the devices.
 The devices should perform as intended by the manufacturer and be
designed, manufactured and packaged in a manner to enable intended
use.
 The above three characteristics should not deteriorate to such a point
during the shelf life of a medical device, as specified by the
manufacturer.

13.  The devices should be designed, manufactured and packaged in a
manner that their performance or characteristics are not damaged
due to regular transport and storage conditions e.g. temperature
variation, humidity, etc.
 Each medical device must have clinical evidence for intended use
and classification under the ‘Medical Devices Rules, 2017’,
demonstrating compliance with essential principles.
 Manufacturers of IVD medical devices follow specified procedures
during design, manufacture and marketing.

14. S.No Medical Devices In-vitro Diagnostic devices
1 Definition Medical devices are
instruments apparatus,
appliance, material or
other article and
accessories to such
items as intended by
the manufacturer to be
used on human beings
for diagnosis,
prevention,
monitoring, treatment
or alleviation of
diseases.
IVD are medical devices and
accessories used In-vitro for
performing tests on samples such
as blood, urine, tissues taken
from the human body in order to
help detect infections, prevent
diseases, diagnose a medical
condition
2 Use In-vivo and ex-vivo use In- vitro use
Difference between Medical devices and Ivd’s

15. S.No Medical Devices In-Vitro Diagnostic
Devices
3 Active
Compone
nts
mechanical, electrical materials.
Many medical devices incorporate
and are driven by software.
Biological core
reagents
4 Purpose Diagnostic or therapeutic intended
use
Diagnostic intended
use
5 Examples Pacemakers, MRI machine, X-ray
machine, Ultrasound machines, Hip
implants, Sutures, tongue
depressors, bed pans, Blood glucose
meters.
Hepatitis tests, HIV
tests, Coagulation test
systems, Pregnancy
tests, Urine test strips,
Blood sugar
monitoring systems
for diabetes patients,
etc.

16. Combination Product
Combination products are defined in 21 CFR 3.2(e). The term combination
product includes:
 A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic, that
are physically, chemically, or otherwise combined or mixed and produced
as a single entity.
Two or more separate products packaged together in a single package or as
a unit and comprised of drug and device products, device and biological
products, or biological and drug products.

17. Classification of Combination Products
Combination products can be generally categorized into
separate classes based on their specific components:
Novel drug delivery systems.
Conventional drug delivery systems.
Drug-enhanced devices.
Regenerative medicinal products.

18. Novel drug delivery systems :
 These products are designed to improve the convenience and comfort
of administration, and drug effectiveness through enable delivery of a
drug localized administration.
 It refers to the approaches, formulations, technologies, and systems
for transporting a pharmaceutical compound in the body as needed to
safely achieve its desired therapeutic effects.
These products would be primarily ownered by the Center for Drug
Evaluation and Research (CDER) .

19. Examples:
 Nanoparticles
 Microemulsions
 Matrix systems
 Solid dispersions
 Liposomes
 Solid lipid nanoparticles

20. Conventional drug delivery systems :
▪ These products combine or package drugs together with injection devices to
improve convenience of administration.
▪ These components can also be regulated separately using the established
regulatory regimes for drugs and devices.
▪ Conventional routes for drug delivery are oral, buccal, rectal, subcutaneous,
intranasal, intramuscular, intravenous, pulmonary and transdermal.
Examples:
Pen-based delivery systems
Drug pumps
Profiled syringes
Auto injectors

21. Drug-enhanced devices: These products combine existing devices with
existing drugs enhance the functionality, performance, or efficacy of these
devices .
Examples:
• Drug-eluting stents(DES)
• Bone cements with antimicrobial agents
• Other devices with antimicrobial coatings
• Disinfective sutures
Drug-eluting stents(DES)

22. Regenerative medicinal products:
 These products that combine devices with biologically
facilitate/enhance healing and active substances to regeneration of
damaged tissues.
 The device often serves as the support structure for the growth of the
biologic component with the product often being an implant.
Examples:
 Absorbable meshes for bone growth
 Dermagraft (human fibroblast-derived dermal substitute)
 Artificial replacement organs (such as the bio-artificial pancreas)

23. 1. Define and classify medical devices as per USFDA and CDSCO?
2. What is combination product and classify them with examples?
3. What are the essential principles of medical devices and Ivd’s?

24. REFERENCES
1. FDA medical devices - Search (bing.com)
2.FDA ivds - Search (bing.com)
3.medical devices classification - Bing images
4.Principles of In Vitro Diagnostic (IVD) Medical Devices
Classification | International Medical Device Regulators Forum
(imdrf.org)
5. Overview of IVD Regulation | FDA