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Medical Device and IVDs Classification Under EU Regulations

Date:Oct 31, 2019

Medical Devices Regulation (EU) 2017/745 will replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). 

The EU Medical Device Regulation 2017/745 (or EU MDR 2017/745) will be mandatory from May 2020 (Unless transition period is extended). In vitro Diagnostic Medical Devices Regulation (IVDR) will be applied from May 2022.


How medical devices are segmented in Europe

Essentially, all devices fall into four basic categories:

•Non-invasive devices

•Invasive medical devices

•Active medical devices

•Special Rules (including contraceptive, disinfectant, and radiological diagnostic medical devices)

 

The MDR (Medical Device Regulation) has a few additional special rules, including one for nanomaterials.

Devices are further segmented into the classes noted below.

Class I – Provided non-sterile or do not have a measuring function (low risk)

Class I – Provided sterile and/or have a measuring function (low/medium risk); the MDR adds to this group, reusable surgical instruments as Class I reusable surgical instruments.

Class IIa (medium risk)

Class IIb (medium/high risk)

Class III (high risk)

old medical device

Specific classification rules are listed in ANNEX IX of Directive 93/42/EEC

Excerpt:

“III. CLASSIFICATION

B

III. CLASSIFICATION

1. Non-invasive devices

1.1. Rule 1

All non-invasive devices are in Class I, unless one of the rules set out

hereinafter applies.

1.2. Rule 2

All non-invasive devices intended for channelling or storing blood, body

liquids or tissues, liquids or gases for the purpose of eventual infusion,

administration or introduction into the body are in Class IIa:

if they may be connected to an active medical device in Class IIa or a

higher class,

if they are intended for use for storing or channelling blood or other

body liquids or for storing organs, parts of organs or body tissues,

in all other cases they are in Class I.

1993L0042 — EN — 11.10.2007 — 005.001 — 53

B

1.3. Rule 3

All non-invasive devices intended for modifying the biological or chemical

composition of blood, other body liquids or other liquids intended for

infusion into the body are in Class IIb, unless the treatment consists of

filtration, centrifugation or exchanges of gas, heat, in which case they are in

Class IIa.

1.4. Rule 4

All non-invasive devices which come into contact with injured skin:

are in Class I if they are intended to be used as a mechanical barrier, for

compression or for absorption of exudates,

are in Class IIb if they are intended to be used principally with wounds

which have breached the dermis and can only heal by secondary intent,

are in Class IIa in all other cases, including devices principally intended

to manage the micro-environment of a wound.

2. Invasive devices

2.1. Rule 5

M5 All invasive devices with respect to body orifices, other than

surgically invasive devices and which are not intended for connection to

an active medical device or which are intended for connection to an active

medical device in Class I:

are in Class I if they are intended for transient use,

are in Class IIa if they are intended for short-term use, except if they

are used in the oral cavity as far as the pharynx, in an ear canal up to

the ear drum or in a nasal cavity, in which case they are in Class I,

are in Class IIb if they are intended for long-term use, except if they are

used in the oral cavity as far as the pharynx, in an ear canal up to the

ear drum or in a nasal cavity and are not liable to be absorbed by the

mucous membrane, in which case they are in Class IIa.

All invasive devices with respect to body orifices, other than surgically

invasive devices, intended for connection to an active medical device in

Class IIa or a higher class, are in Class IIa.

M5

2.2. Rule 6

All surgically invasive devices intended for transient use are in Class IIa

unless they are:

intended specifically to control, diagnose, monitor or correct a defect of

the heart or of the central circulatory system through direct contact with

these parts of the body, in which case they are in Class III,

reusable surgical instruments, in which case they are in Class I,

intended specifically for use in direct contact with the central nervous

system, in which case they are in Class III,

intended to supply energy in the form of ionising radiation in which case

they are in Class IIb,

intended to have a biological effect or to be wholly or mainly absorbed

in which case they are in Class IIb,

intended to administer medicines by means of a delivery system, if this

is done in a manner that is potentially hazardous taking account of the

mode of application, in which case they are in Class IIb.

B

2.3. Rule 7

All surgically invasive devices intended for short-term use are in Class IIa

unless they are intended:

M5

either specifically to control, diagnose, monitor or correct a defect of the

heart or of the central circulatory system through direct contact with

these parts of the body, in which case they are in Class III,

1993L0042 — EN — 11.10.2007 — 005.001 — 54

B

or specifically for use in direct contact with the central nervous system,

in which case they are in Class III,

or to supply energy in the form of ionizing radiation in which case they

are in Class IIb,

or to have a biological effect or to be wholly or mainly absorbed in

which case they are in Class III,

or to undergo chemical change in the body, except if the devices are

placed in the teeth, or to administer medicines, in which case they are in

Class IIb.

2.4. Rule 8

All implantable devices and long-term surgically invasive devices are in

Class IIb unless they are intended:

to be placed in the teeth, in which case they are in Class IIa,

to be used in direct contact with the heart, the central circulatory system

or the central nervous system, in which case they are in Class III,

to have a biological effect or to be wholly or mainly absorbed, in which

case they are in Class III,

or to undergo chemical change in the body, except if the devices are

placed in the teeth, or to administer medicines, in which case they are in

Class III.

3. Additional rules applicable to active devices

3.1. Rule 9

All active therapeutic devices intended to administer or exchange energy are

in Class IIa unless their characteristics are such that they may administer or

exchange energy to or from the human body in a potentially hazardous way,

taking account of the nature, the density and site of application of the

energy, in which case they are in Class IIb.

All active devices intended to control or monitor the performance of active

therapeutic devices in Class IIb, or intended directly to influence the

performance of such devices are in Class IIb.

3.2. Rule 10

Active devices intended for diagnosis are in Class IIa:

if they are intended to supply energy which will be absorbed by the

human body, except for devices used to illuminate the patient's body, in

the visible spectrum,

if they are intended to image in vivo distribution of radiopharmaceuticals,

if they are intended to allow direct diagnosis or monitoring of vital

physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is

such that it could result in immediate danger to the patient, for instance

variations in cardiac performance, respiration, activity of CNS in which

case they are in Class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which

control or monitor such devices, or which directly influence their

performance, are in Class IIb.

Rule 11

All active devices intended to administer and/or remove medicines, body

liquids or other substances to or from the body are in Class IIa, unless this

is done in a manner:

that is potentially hazardous, taking account of the nature of the

substances involved, of the part of the body concerned and of the

mode of application in which case they are in Class IIb.

3.3. Rule 12

All other active devices are in Class I.

1993L0042 — EN — 11.10.2007 — 005.001 — 55

B

4. Special Rules

4.1. Rule 13

All devices incorporating, as an integral part, a substance which, if used

separately, can be considered to be a medicinal product, as defined in

Article 1 of Directive M5 2001/83/EC , and which is liable to act

on the human body with action ancillary to that of the devices, are in

Class III.

M5

All devices incorporating, as an integral part, a human blood derivative are

in Class III.

B

4.2. Rule 14

All devices used for contraception or the prevention of the transmission of

sexually transmitted diseases are in Class IIb, unless they are implantable or

long term invasive devices, in which case they are in Class III.

4.3. Rule 15

All devices intended specifically to be used for disinfecting, cleaning,

rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specifically to be used for disinfecting medical devices

are in Class IIa. M5 Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.

This rule does not apply to products that are intended to clean medical

devices other than contact lenses by means of physical action.

4.4. Rule 16

M5 Devices specifically intended for recording of X-ray diagnostic

images are in Class IIa.

4.5. Rule 17

All devices manufactured utilizing animal tissues or derivatives rendered

non-viable are Class III except where such devices are intended to come

into contact with intact skin only.

5. Rule 18

By derogation from other rules, blood bags are in Class IIb.”

 

The EU MDR 2017/745 has 4 main categories for Medical Devices classification:

Class I

Class IIa

Class IIb

Class III

This goes from the products with low risk (Class I) to the products with high risk (Class III).

3 sub-classes under class I:

Class Is: It’s a class I product that is delivered sterile

Class Im: It’s a product with a measuring function

Class Ir: New sub-class for products that are reprocessed.

And for those 3 sub-classes, a notified body should be involved for the certification. But only for the specific sub-class (Sterilization, measuring function or reprocessing validation)

Specific classification rules are listed in ANNEX VIII of EU MDR 2017/745

Excerpt:

“CHAPTER III

CLASSIFICATION RULES

4. NON-INVASIVE DEVICES

4.1. Rule 1

All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.

4.2. Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases

for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:

if they may be connected to a class IIa, class IIb or class III active device; or

if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts

of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.

In all other cases, such devices are classified as class I.

4.3. Rule 3

All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells,

blood, other body liquids or other liquids intended for implantation or administration into the body are classified

as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of

gas, heat, in which case they are classified as class IIa.

All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct

contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos

before their implantation or administration into the body are classified as class III.

4.4. Rule 4

All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:

class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;

class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or

mucous membrane and can only heal by secondary intent;

5.5.2017 EN Official Journal of the European Union L 117/141

class IIa if they are principally intended to manage the micro-environment of injured skin or mucous

membrane; and

class IIa in all other cases.

This rule applies also to the invasive devices that come into contact with injured mucous membrane.

5. INVASIVE DEVICES

5.1. Rule 5

All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended

for connection to an active device or which are intended for connection to a class I active device are classified as:

class I if they are intended for transient use;

class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx,

in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and

class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx,

in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous

membrane, in which case they are classified as class IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection

to a class IIa, class IIb or class III active device, are classified as class IIa.

5.2. Rule 6

All surgically invasive devices intended for transient use are classified as class IIa unless they:

are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central

circulatory system through direct contact with those parts of the body, in which case they are classified as

class III;

are reusable surgical instruments, in which case they are classified as class I;

are intended specifically for use in direct contact with the heart or central circulatory system or the central

nervous system, in which case they are classified as class III;

are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;

have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or

are intended to administer medicinal products by means of a delivery system, if such administration of

a medicinal product is done in a manner that is potentially hazardous taking account of the mode of

application, in which case they are classified as class IIb.

5.3. Rule 7

All surgically invasive devices intended for short-term use are classified as class IIa unless they:

are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central

circulatory system through direct contact with those parts of the body, in which case they are classified as

class III;

are intended specifically for use in direct contact with the heart or central circulatory system or the central

nervous system, in which case they are classified as class III;

are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;

have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;

are intended to undergo chemical change in the body in which case they are classified as class IIb, except if

the devices are placed in the teeth; or

are intended to administer medicines, in which case they are classified as class IIb.

L 117/142 EN Official Journal of the European Union 5.5.2017

5.4. Rule 8

All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:

are intended to be placed in the teeth, in which case they are classified as class IIa;

are intended to be used in direct contact with the heart, the central circulatory system or the central nervous

system, in which case they are classified as class III;

have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;

are intended to undergo chemical change in the body in which case they are classified as class III, except if the

devices are placed in the teeth;

are intended to administer medicinal products, in which case they are classified as class III;

are active implantable devices or their accessories, in which cases they are classified as class III;

are breast implants or surgical meshes, in which cases they are classified as class III;

are total or partial joint replacements, in which case they are classified as class III, with the exception of

ancillary components such as screws, wedges, plates and instruments; or

are spinal disc replacement implants or are implantable devices that come into contact with the spinal

column, in which case they are classified as class III with the exception of components such as screws,

wedges, plates and instruments.

6. ACTIVE DEVICES

6.1. Rule 9

All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their

characteristics are such that they may administer energy to or exchange energy with the human body in

a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in

which case they are classified as class IIb.

All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or

intended directly to influence the performance of such devices are classified as class IIb.

All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or

monitor such devices, or which directly influence their performance, are classified as class IIb.

All active devices that are intended for controlling, monitoring or directly influencing the performance of active

implantable devices are classified as class III.

6.2. Rule 10

Active devices intended for diagnosis and monitoring are classified as class IIa:

if they are intended to supply energy which will be absorbed by the human body, except for devices intended

to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;

if they are intended to image in vivo distribution of radiopharmaceuticals; or

if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are

specifically intended for monitoring of vital physiological parameters and the nature of variations of those

parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac

performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical

situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including

interventional radiology devices and devices which control or monitor such devices, or which directly influence

their performance, are classified as class IIb.

5.5.2017 EN Official Journal of the European Union L 117/143

6.3. Rule 11

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes

is classified as class IIa, except if such decisions have an impact that may cause:

death or an irreversible deterioration of a person's state of health, in which case it is in class III; or

a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as

class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for

monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it

could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

6.4. Rule 12

All active devices intended to administer and/or remove medicinal products, body liquids or other substances to

or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking

account of the nature of the substances involved, of the part of the body concerned and of the mode of

application in which case they are classified as class IIb.

6.5. Rule 13

All other active devices are classified as class I.

7. SPECIAL RULES

7.1. Rule 14

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be

a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product

derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has

an action ancillary to that of the devices, are classified as class III.

7.2. Rule 15

All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified

as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.

7.3. Rule 16

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating

contact lenses are classified as class IIb.

All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa,

unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting

invasive devices, as the end point of processing, in which case they are classified as class IIb.

This rule does not apply to devices that are intended to clean devices other than contact lenses by means of

physical action only.

7.4. Rule 17

Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as

class IIa.

L 117/144 EN Official Journal of the European Union 5.5.2017

7.5. Rule 18

All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are nonviable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or

cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended

to come into contact with intact skin only.

7.6. Rule 19

All devices incorporating or consisting of nanomaterial are classified as:

class III if they present a high or medium potential for internal exposure;

class IIb if they present a low potential for internal exposure; and

class IIa if they present a negligible potential for internal exposure.

7.7. Rule 20

All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to

administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential

impact on the efficacy and safety of the administered medicinal product or they are intended to treat lifethreatening conditions, in which case they are classified as class IIb.

7.8. Rule 21

Devices that are composed of substances or of combinations of substances that are intended to be introduced

into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the

human body are classified as:

class III if they, or their products of metabolism, are systemically absorbed by the human body in order to

achieve the intended purpose;

class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their

products of metabolism, are systemically absorbed by the human body;

class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx,

and achieve their intended purpose on those cavities; and

class IIb in all other cases.

7.9. Rule 22

Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines

the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.”


How IVDs are classified in Europe

IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC).

Offering In vitro Diagnostics Devices in the European Union (EU) requires compliance with the In vitro diagnostic Directive (IVDD; directive 98/79/EC), which lists devices requiring specific assessments:

Self-Testing IVD Devices

Annex II, list A (e.g., blood grouping, HIV screening)

Annex II, list B (e.g., HLA grouping; detection of Chlamydia, Rubella; monitoring blood glucose).

The involvement of a Notified Body is necessary for IVD medical devices listed in Annex II of the IVD Directive 98/79/EC and for IVD medical devices designed for self-testing.

IVDD Evolutions

Future IVD classification system

The IVD classification scheme is expected to change from an exclusive, list-based system to risk-based classification scheme with four classes (A to D) and seven classification rules to determine which IVD belongs in which class.

The proposed regulation introduces four risk-based classes, based on the GHTF classification of medical devices: A, B, C, and D.

IVDs are classified into one of these classes by taking into account their intended use, the risk of the disease or condition for which they test, their novelty and complexity, and the inherent risks to using the device itself

IVD classification






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