MEDICAL DEVICES

CLASSIFICATION

Medical Devices Rules 2015

 Classification Methodology

 All medical devices are classified into four classes,

namely, Class A, Class B, Class C and Class D
depending on the level of risk it poses to patients,
users and other persons.

 Risk means combination of the probability of

occurrence of harm and the severity of that harm.

 Harm means physical injury or damage to the health

of people or damage to property or the environment.
 Risk level VS Class

Classification Risk Level

A Low
B Low- Moderate

C Moderate –High

D High
 Non-invasive medical devices

Class A
Rule 1: Rule 2: Rule 4: Which either do
In Contact with injured Intended for channeling not touch the patient or
skin, used as a or storing liquids, contact only intact skin.
mechanical barrier, for tissues or gases for
compression or for eventual infusion,
absorption of exudates administration or
e.g. Simple wound introduction into the
dressings, cotton wool, body e.g.,
etc. administration sets for
gravity infusion.
 Non-invasive medical devices

Class B
Rule 1: Rule 2: Rule 3: modification includes simple
Used with wounds a) Connected to an active medical mechanical filtration or
which have breached device in Class B or a higher class. centrifugation, e.g., devices to
the dermis. e.g., non- e.g., syringes/administration sets remove carbon dioxide, particulate
medicated for infusion pumps, anesthesia filters in an extracorporeal
impregnated gauze breathing circuits, etc. circulation system, etc..
dressings, etc. b) Channeling blood/body liquids,
storing organs, parts of organs or
body tissues, e.g., tubes used for
blood transfusion, organ storage
containers, blood bags that do not
incorporate an anti-coagulant, etc.
 Non-invasive medical devices

Class C
Rule 1: Rule 2: Rule 3: modification does
Can only heal by secondary Blood bags not include simple
intent e.g., dressings for mechanical filtration or
chronic ulcerated wounds, centrifugation, e.g.
dressings for severe burns, haemodialisers, devices
etc. to remove white blood
cells from whole blood,
etc.
 Invasive medical devices

Class A
Rule 1: Rule 3:
a) All invasive medical devices other than All surgically invasive medical devices
surgically invasive and intended for intended for transient use. Reusable surgical
connection to a Class A active medical device. instruments, e.g., manually operated
surgical drill bits and saws etc.
b) intended for transient use, e.g.,
examination gloves, enema devices.
c) Intended for short-term use in the oral
cavity, pharynx, nasal cavity, in an ear canal
up to the ear drum e.g., dentures intended to
be removed by the patient, dressings for
nasal bleedings, etc.
 Invasive medical devices

Class B
Rule 1: Rule 2:
a) Intended for short-term use, e.g., urinary All invasive medical devices other than
catheters, tracheal tubes etc. surgically invasive and intended for
connection to a Class B active medical
b) Intended for long-term use in the oral
device or a higher class. They are
cavity, nasal cavity, pharynx, ear canal up
independent of time. e.g., tracheal tubes
to the ear-drum and not liable to be
connected to a ventilator, suction
absorbed by the mucous membrane, e.g.,
catheters for stomach drainage, dental
orthodontic wire, fixed dental prosthesis,
aspirator
etc.
 Invasive medical devices

Class B
Rule 3: Rule 4:
a) those that create a conduit through the All surgically invasive medical devices
skin e.g., syringe needles or lancets intended for short-term use post-
operative care or are infusion devices or
b) surgical instruments e.g., single-use
are catheters of various types, e.g.,
scalpels or surgical staplers or single-use
infusion canola, temporary filling
aortic punch, surgical gloves and various
materials, non-absorbable skin closure
types of catheter or sucker, etc.
devices, tissue stabilizers used in cardiac
c) surgical instruments, other than those in surgery etc.
Class D, if supplied sterile and intended for
single use.
 Invasive medical devices

Class C
Rule 1: Rule 3:
Intended for long- term use, e.g., urethral a) supply energy in the form of ionizing
stents, contact lenses radiation, e.g., catheter incorporating or
containing sealed radioisotopes, etc.
b) have a biological effect or be wholly or
mainly absorbed
c) administer medicinal products by
means of a delivery system e.g., insulin
pen for self-administration etc.
 Invasive medical devices

Class C
Rule 4: Rule 5:
a) administer medicinal products Implants used in the orthopaedic, dental,
ophthalmic and cardiovascular fields,
b) undergo chemical change in the body
e.g., maxilla-facial implants, prosthetic
except if the devices are placed in the
joint replacements, bone cement, non-
teeth, e.g., surgical adhesive, etc.
absorbable internal sutures, posts to
c) supply energy in the form of ionizing secure teeth to the mandibula bone
radiation, e.g., brachytherapy device, etc. without a bioactive coating.
 Invasive medical devices

Class D
Rule 3: Rule 4:
a) for use in direct contact with the central a) have a biological effect or to be wholly or
nervous system mainly absorbed, e.g., absorbable suture,
biological adhesive, etc.
b) to diagnose, monitor or correct a defect
b) specifically for use in direct contact with
of the heart or of the central circulatory
the central nervous system, e.g.
system e.g., angioplasty balloon catheters Neurological catheter,
and related guide wires, dedicated
disposable cardiovascular surgical c) to diagnose, monitor or correct a defect
instruments, etc. of the heart or central circulatory system
through direct contact e.g., cardiovascular
catheters, temporary pacemaker leads.
 Invasive medical devices

Class D
Rule 5:
a) intended to be used in direct contact with the heart,central circulatory system or the
central nervous system, e.g., prosthetic heart valves, spinal and vascular stents, etc.
b) intended to be life supporting or life sustaining
c) active implantable medical devices, e.g., pacemakers, their electrodes and their leads,
implantable defibrillators, etc.
d) have a biological effect or to be wholly or mainly absorbed, e.g., implants claimed to be
bioactive, etc.
e) administer medicinal products, e.g., rechargeable non-active drug delivery system, etc
f) undergo chemical change in the body except if the devices are placed in the teeth
g) breast implants.
 Active medical devices
Class A
Rule 3:
intended to supply energy which will be
absorbed by the human body e.g.,
magnetic resonance equipment, diagnostic
ultrasound in non-critical applications,
evoked response stimulators, etc.
Rule 5:
All active medical devices other than
those specified in sub-rule (1) to (4) e.g.,
examination lamps, surgical microscopes,
powered hospital beds and wheelchairs,
powered equipment for the recording,
processing, viewing of diagnostic images,
dental curing lights etc.
 Active medical devices
Class B
Rule 1:
All active therapeutic medical devices
intended to administer or exchange energy
e.g., muscle stimulators, powered dental
hand pieces, hearing aids, neonatal
phototherapy equipment, ultrasound
equipment for physiotherapy, etc
Rule 3:equipment for ultrasonic diagnosis
or imaging
a) intended to image in-vivo distribution
of radiopharmaceuticals, e.g., gamma or
nuclear cameras
b) allow direct diagnosis or monitoring of
vital physiological processes, e.g.,
electronic thermometers, stethoscopes
and blood pressure monitors,
electrocardiographs, etc.
 Active medical devices

Class B
Rule 4:
Drug delivery systems or anaesthesia equipment, e.g., suction equipment, feeding
pumps, jet injectors for vaccination, nebuliser to be used on conscious and
spontaneously breathing patients
 Active medical devices

Class C
Rule 1: Rule 2:a) intended to control or monitor
the performance of active therapeutic
administer or exchange energy to or from medical devices
the human body in a potentially hazardous
way e.g., lung ventilators, baby incubators, b) influence the performance of such
medical devices.
electrosurgical generators, external
pacemakers and defibrillators, surgical c) emit ionizing radiation and intended
lasers, lithotripters, therapeutic X-ray and for diagnostic or interventional radiology,
including devices which control or
other sources of ionizing radiation etc.
monitor such devices, or those which
directly influence their performance
 Active medical devices

Class C
Rule 3: Rule 4:
intended for monitoring of vital administration or removal of medicinal
physiological parameters e.g., monitors or products, body liquids or other
alarms for intensive care, biological substances to or from the body is done in
a manner that is potentially hazardous
sensors, oxygen saturation monitors, e.g., infusion pumps, anesthesia
apnea monitors equipment, dialysis equipment,
b) diagnosing in clinical situations where hyperbaric chambers, nebulizer
the patient is in immediate danger, e.g.,
ultrasound equipment for use in
interventional cardiac procedures
 Active medical devices

(Additional Methods)
Class A
if manufactured from or incorporate non-
viable animal tissues or their derivatives
that come in contact with intact skin only,
e.g., leather components of orthopedic
appliances, etc.
Class B
if they are intended for disinfecting
medical devices prior to end point
sterilization or higher level disinfection,
e.g., washer disinfectors, etc.
 Active medical devices

(Additional Methods)
Class C
a) for sterilizing medical devices, or disinfecting as the end point of processing, e.g.,
medical devices for disinfecting or sterilizing endoscopes, disinfectants intended to be
used with medical devices etc.
b) used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact
lenses.
c) used for contraception or the prevention of the transmission of sexually
transmitted diseases, e.g., condoms, contraceptive diaphragms, etc
 Active medical devices

(Additional Methods)
Class D
a) incorporating a substance which, if used separately, can be considered to be a
medicinal product e.g., antibiotic bone cements, heparin-coated catheters, wound
dressings incorporating antimicrobial agents to provide ancillary action on the wound,
blood bags incorporating an anti- coagulant
b) manufactured from or incorporating animal or human cells, tissues or derivatives
thereof, whether viable or non-viable, e.g., porcine heart valves, catgut sutures, etc
c) if they are implantable or long-term invasive medical devices, e.g., intrauterine

Sohail
contraceptive medical device, etc.

Muhammad Sohail (Pharm-D,R.Ph)