Week 2 - Topic 1b (Risk classification for MDs)

Question 1

Medical devices risk is classified based on how many categories ? Name the given categories

Answer 1

4 categories.
For Asean : A,B,C,D
For EU : I, IIa, IIb, III
Ranges from low risk, medium-low risk, medium-high risk, high risk

Question 2

what are the main areas to regulate and monitor

3 Areas

Answer 2

Safety, Performance, Quality

Question 3

Define “Device Failures”

Answer 3

• Devices fails to perform (performance issue)
• Devices performs BUT with adverse event results (Safety issues)
• Devices performance is inconsistent (Quality issues)

Question 4

How are Risks in medical devices classified ?

Answer 4

Risk class of medical devices is determined by applying a set of classification rules

Question 5

what factor is taken in consideration when doing risk classification ? ( 4 Factors)

Answer 5

• Degree of invasiveness
• Duration of devices contact with the body
• Local or systemic effect
• Delivery of energy or medicinal products

Question 6

What factors determines a device ‘s risk ? (2 factors)

Answer 6

• Intended purpose
• Indications

However, actual classic action depends on the claims made by the product owner and on its intended use

Question 7

what is the intended used of a medical devices

Answer 7

Broken down into 4 parts
•Diseases
•Injury 
•Anatomy or physiological processes 
•Other medical purposes

Question 8

Explain how “Diseases” is one of the intended use of a medical devices

Answer 8

4 points. [ Elaborate in your own way]
•Diagnosis 
•Prevention
•Monitoring 
•Treatment 
•Alleviation

Question 9

Explain how “Injury” is one of the intended use of medical devices

Answer 9

4 points [ Elaborate in your own way]
•Diagnosis
•Monitoring 
•Treatment 
•Compensation

Question 10

Explain how “Anatomy or physiological processes” is one of the intended use of medical devices

Answer 10

• Investigation
• Replacement
• Modification
• Support

Question 11

Explain how “Other medical purposes” is one of the intended use of medical devices

Answer 11

• Supporting or sustaining life
• Control of conception
• Disinfection of medical devices
• Providing information by means of in vitro examination

Question 12

Explain the term “In VITRO Diagnostic”

Answer 12

Any reagent, reagent product, control material ,equipment or system whether used alone or In combination with any other reagent, reagent product, control material, equipment or system that its product owner to be used in vitro for the examination of any specimen, including any blood or tissue donation , derived from the human body, sole or principally for the purpose of providing information
•Concerning a physiological or pathological state or a congenital abnormality
•To determine the safety and compatibility of any blood or tissue donation with potential recipient thereof
•To monitor therapeutic measures
•Includes a specimen receptacle

Question 13

16 risk classification is broken down into how many sections

Answer 13

4 sections. 
1 - 4
5 -8
9 - 12
13 - 16

Question 14

Rule 1-4 under medical risk classification falls under invasive or non-invasive ?

Answer 14

Non-Invasive ( no contact / Skin contact )

Question 15

Under invasive, how many categories is it being divided into

Answer 15

2 categories : Body orifice & Surgically invasive

Question 16

what rules does body orifice falls under

Answer 16

Rule 5

Question 17

Define body orifice

Answer 17

Any natural opening in the body as well as the external surfaces of the eyeball, or any permanent artificial opening.

Question 18

What does rule 5-8 fall under

Answer 18

Surgically invasive

Question 19

Define surgically invasive

Answer 19

Penetrates inside the body through surfaces of the body, with the aid of or in the context of a surgical operation

Question 20

What does rule 9-12 fall under

Answer 20

Falls under “Active devices” where it is spilt into 3categories :
•Administer or exchange energy
•Administer or remove medicinal products, body liquid or other substances
•Others

Question 21

Under Active devices “Administer or exchange energy” it is then again spilt into 2 parts. What are the 2 parts

Answer 21

Active therapeutic / Active Diagnostic

Question 22

Define “Active”

Answer 22

Medical devices that operates depending on the source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy

Question 23

Define “Active therapeutic”

Answer 23

An active medical device used whether alone or in combination with any other medical device to support, modify, replace or restore biological functions

Question 24

Define “Active diagnostic”

Answer 24

An active devices used whether alone or in combination with any other medical device, to supply information for detecting , diagnosing or monitoring, or to provide support In the treatment of, any physiological condition, state of health, illness or congenital deformity.

Question 25

What rule would be the same as rule 5-8

Answer 25

Rule 9-12

Question 26

Define “Software classification”

Answer 26

• Software that is incorporated into the Medical device itself. Classified according to the intended use of the combination system.
• Software that is independent of any other medical device. It is classified in its own right as a medical device. Standalone software is deemed to be an active device.

Question 27

What is local effect

Answer 27

Local refers to the effect on the body part where the device is physically placed in contact with

Question 28

What is systemic effect

Answer 28

systemic means affecting distant body systems and organs rather than being localized in one area or organ.