Medical Devices: Legislation and Classification (Ch. 8)

Question 1

What is the purpose of the medical device classification system?

Answer 1

To evaluate the risk profile of a device, indicating the level of regulatory controls and the conformity assessment procedures required

Question 2

What is the definition of a medical device?

Answer 2

Medical Device:
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- Investigation, replacement, or modification of the anatomy or physiological or pathological process or state
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means

Question 3

What is the definition of a medical device accessory?

Answer 3

Medical Device Accessory:
An article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose?(s) or to specifically and directly assist the functionality of the medical device(s) in terms of its/their intended purpose(s)

Question 4

What is the definition of a custom-made device?

Answer 4

Custom-Made Device:
Specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs

Question 5

What is the definition of an in vitro diagnostic (IVD)?

Answer 5

IVD:
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- Concerning a physiological or pathological process or state
- Concerning congenital physical or mental impairments
- Concerning the predisposition to a medical condition or a disease
- To determine the safety and compatibility with potential recipients
- To predict treatment response or reactions
- To define or monitor therapeutic measures

Question 6

What is the definition of specimen receptacles?

Answer 6

Specimen receptacles:
A device, whether or vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination

Question 7

What is the definition of intended purpose?

Answer 7

Intended purpose:

The use for which a device is intended

Question 8

What is the first step of the classification process?

Answer 8

Determining if the product is a medical device 
(From this, the regulation can be identified (MDR vs. IVDR), and the device class can then be determined)

Question 9

Where are the classification rules found in the MDD and MDR?

Answer 9

MDD: Annex IX (9)
MDR: Annex VIII (8)

Question 10

What are the main characteristics of a device that are considered for classification?

Answer 10

The device’s intended purpose and mode of action

Question 11

What are the four groups of classification rules in the MDD/MDR?

Answer 11

1. Non-invasive devices
2. Invasive devices
3. Active devices
4. Special rules

Question 12

What are the three types of devices that are not classified / fall outside of the classification system?

Answer 12

1. Custom-made devices
2. Investigational devices
3. Orphan devices

Question 13

What is the difference between IVDD and IVDR classification systems?

Answer 13

IVDD: A list-based approach that assigned certain devices to Annex I and II
IVDR: A risk-based approach where devices are now classified into four classes: A, B, C, and D

Question 14

Under the IVDR, what is the highest risk class?

Answer 14

Class D is the highest risk, Class A is the lowest risk

Question 15

TRUE/FALSE: Only one classification rule can apply to a device.

Answer 15

FALSE - Multiple classification rules can apply to one device. The rule with the highest risk class applies.

Question 16

TRUE/FALSE: If a device has multiple purposes or can be used in different applications, only one needs to be considered for classification.

Answer 16

FALSE: All applications/intended purposes should be considered, and the application resulting in the highest class should be used for classification

Question 17

TRUE/FALSE: Individual devices that are used in a system can be classified individually, or the system can be classified as a whole.

Answer 17

TRUE

Question 18

What are the 4 key device characteristics considered for classification?

Answer 18

1. Time period / duration of use
2. Degree of invasiveness
3. Energy use
4. Biological activity and/or incorporation of drugs

Question 19

What are the 3 types of duration of use?

Answer 19

1. Transient (Continuous use for less than 60 mins)
2. Short-term (Continuous use between 60 mins and 30 days)
3. Long-term (Continuous use more than 30 days)

Question 20

What is the definition of an invasive device?

Answer 20

Invasive Device:
A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body

Question 21

What is the definition of body orifice?

Answer 21

Body Orifice:

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

Question 22

What is the definition of a surgically invasive device?

Answer 22

Surgically invasive device:
An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation, or as a device which produces penetration other than through a body orifice
(Ex. needles, surgical gloves

Question 23

What are the two types of surgically invasive devices?

Answer 23

Implants and reusable surgical instruments

Question 24

What is the definition of an implantable device?

Answer 24

Implantable device:
Any device which is intended to be totally introduced into the human body or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure

Question 25

What is the definition of an active device?

Answer 25

Active device:
Any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy

Question 26

What is the definition of absorption?

Answer 26

Absorption:
A material’s degradation within the body and the metabolic elimination of the resulting degradation products from the body

Question 27

What does it mean for a device to have a biological effect or be absorbed?

Answer 27

If the device intentionally and actively induces, alters, or prevents a response from the tissues that is mediated by specific reactions at a molecular level

Question 28

What are drug-device combination products (DDCs)?

Answer 28

Drug-device combination products (DDCs):
Medicinal product(s) with medical device/device components necessary for administration, correct dosing, or use of the medicinal product

Question 29

What are integral DDCs?

Answer 29

Integral DDCs:
Incorporate, as an integral part, a substance that, if used separately, would be considered as a medicinal product, or they are single-use devices that administer a medicinal product
(Ex. pre-filled syringes)

Question 30

What are non-integral DDCs?

Answer 30

Non-integral DDCs:
Have two or more separate components that are not sold physically integrated, but where the medicinal component and devices are used together for administration
(Ex. refillable injectors, reusable inhalers)

Question 31

What are the MDD/MDR classification rules?

Answer 31

Rules 1-4: non-invasive devices
Rules 5-8: invasive devices
Rules 9-13: active devices (MDD: 9-12)
Rules 14-22: special rules (MDD: 13-18)

Question 32

What are the main implementing rules of classification?

Answer 32

1. Intended purpose is the primary consideration
2. Classify according to most critical use
3. If several rules apply, highest class applies
4. Rules applied to device and accessories separately

Question 33

What are the implementing rules related to software?

Answer 33

1. Software embedded in or operating a device is classified the same as the device
2. Independent software shall be classified in its own right
3. Software is considered an ACTIVE medical device

Question 34

What is a resource for determining if a device is a medical device or IVD (borderline device)?

Answer 34

The Borderline Manual - Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

Question 35

What products are defined in EU MDR Annex XVI (16)?

Answer 35

Annex XVI: Products that do not have a medical purpose

Question 36

What is a summary of the IVDR classification process?

Answer 36

Annex VIII
7 rules
4 IVD classes: A (low risk), B, C, and D (high risk)

Question 37

What is a summary of the IVDR conformity assessment route?

Answer 37

Class A: Create Technical Documentation, DofC

Classes B, C, and D: Subject to a conformity assessment

Question 38

If a manufacturer and notified body disagree on device classification, what happens?

Answer 38

NB will request a solution from CA,

The CA will notify the Commission/MDCG of its decision