Classification Tool

Whats the type of your Medical Device? *Select the type of your Medical Device to determine the apllicable resolution

Is the medical device active or non-active? *An active device depends on an energy source not generated by the human body or gravity for its operation.

The device is invasive? *A invasive device penetrates parcially or totally in the body, whether by a body orifice or trough the body surface

What is the main purpose of the active device? *Select the option that best applies

What is the main intended use of the IVD device? *Select the best caracteritic the describes th device function

(Body orifice) How long is the time of use of the device? *Select the continuous use duration

(Surgically) How long is the time of use of the device? *Select the continuous use duration

Is the self-test result a determinant of a critical clinical condition? *Select the option that best applies

Can the erroneous result cause death or serious disability to the individual/fetus/embryo? *Select the option that best applies

Is the device specific to ABO, Rhesus, Kell, Kidd or Duffy systems? *Select the best option that applies

Is the device used for determinations related to notifiable diseases? *Select the option that best applies

Does the software work independently of medical hardware? *Select the option that best applies

What is the main purpose of the software? *Select the option that best applies

What is the potential impact of software-based decisions? *Select the option that best applies

Does the software monitor vital physiological parameters whose variation could result in immediate danger to the patient? *Select the option that best applies

Body orifice, transitory use

Risk Class: I Appliable rule: 5

Body orifice, short term use

Risk Class: II Appliable rule: 5

Body orifice, long term use

Risk Class: III Appliable Rule: 5

Surgically invasive, transitory use

Risk Class: II Appliable Rule: 6

Surgically invasive, short term use

Risk Class: II Appliable Rule: 7

Surgically invasive, long term use

Risk Class: III Appliable Rule: 8

Non-invasive, fluid conduction

Risk Class: II Appliable Rule: 2

Non-invasive, composition change

Risk Class: III Appliable Rule: 3

Non-invasive, damaged skin

Risk Class: II Appliable Rule: 4

Non-invasive, other functions

Risk Class: I Appliable Rule: 1

Result - Transmissible Agents Transfusion

Risk Class: IV Appliable Rule: 1 (a)

Result - Lethal Diseases High Spread

Risk Class: IV Appliable Rule: 1 (b)

Result - Risk of Serious Disability

Risk Class: III Appliable Rule: 3(c)

Result - Specific Blood Groups

Risk Class: IV Appliable Rule: 2 (exceção)

Result - Other Blood Groups

Risk Class: III Appliable Rule: 2

Result - Sexually Transmitted Agents

Risk Class: III Appliable Rule: 3 (a)

Result - Agents in CSF or Blood

Risk Class: III Appliable Rule: 3 (b)

Result - Critical Self-Test

Risk Class: III Appliable Rule: 4

Result - Non-Critical Self-Test

Risk Class: II Appliable Rule: 4 (exceção)

Result - General Reagents

Risk Class: I Appliable Rule: 5 (a)

Result - Material Processing

Risk Class: I Appliable Rule: 5 (b,c,d)

Result - Other IVD

Risk Class: II Appliable Rule: 6 (a)

Result - Controls No Values

Risk Class: II Appliable Rule: 7

Result - Compulsory Notifiable Disease

Risk Class: III Appliable rule: 8

Result (SaMD)

This software is not classified as SaMD as it is embedded in a medical device.

Result - SaMD

Riks Class: IV Rule: 11a

Result - SaMD

Risk Class: III Rule: 11b

Result - SaMD

Risk Class: II Rule: 11

Result - SaMD

Risk Class: III Rule: 11

Result - SaMD

Risk Class: I Rule: 11

Does the non-invasive device fit into any of the following options? *Select the option that best applies

The non-invasive device: *Select the option that best applies

The treatment in which the device is used consists of: *Select the option that best applies

The device is intended for: *Select the option that best applies

The body orifice invasive device: *Select the option that best applies

Does a surgically invasive device for transient use fall into any of these exceptions? *Select the option that best applies

Does a short-term surgically invasive device fall into any of these exceptions? *Select the option that best applies

Does a long-term surgically invasive device fall into any of these exceptions? *Select the option that best applies

The active therapeutic device: *Select the option that best applies

Non-Active Non-Invasive Devices (Rule 1)

Result

Classification: Class I Applicable rule: Rule 1

According to RDC 751/2022, Annex I: "All non-invasive devices are classified in class I, unless one of the following rules applies."

Conductive Non-Active Non-Invasive Devices (Rule 2)

Result

Classification: Class II

Applicable rule: Rule 2

According to RDC 751/2022, Annex I: "All non-invasive devices intended for the conduction or storage of blood, fluids, cells or body tissues, liquids or gases with a view to possible perfusion, administration or introduction into the body are classified in class II: a) if they can be connected to an active device of classes II, III or IV"

Result - Class II (Conduction/storage of fluids):

Result

Classification: Class II

Applicable rule: Rule 2

According to RDC 751/2022, Annex I:
"All non-invasive devices intended for the conduction or storage of blood, fluids, cells or body tissues, liquids or gases with a view to eventual perfusion, administration or introduction into the body are classified in class II: b) if they are intended to be used for the conduction or storage of blood or other body fluids or for the storage of organs, parts of organs or cells and body tissues"

Result - Class I (Other cases):

Result

Classification: Class I Applicable rule: Rule 2

According to RDC 751/2022, Annex I:

"In all other cases, these devices are classified in class I."

Result - Class III (Biological/chemical alteration):

Classification: Class III Applicable rule: Rule 3

According to RDC 751/2022, Annex I:

"All non-invasive devices intended to alter the biological or chemical composition of tissues or cells of human origin, blood, other bodily fluids, or other liquids for implantation or administration into the body are classified in class III"

Result - Class II (Filtration, centrifugation or exchanges):

Classification: Class II Applicable rule: Rule 3

According to RDC 751/2022, Annex I:

"All non-invasive devices intended to alter the biological or chemical composition of tissues or cells of human origin, blood, other bodily fluids, or other liquids for implantation or administration into the body are classified in class III, except if the treatment in which the device is used consists of filtration, centrifugation or gas or heat exchange, in which case they are classified in class II."

Result - Class IV (In vitro use):

Result

Classification: Class IV Applicable rule: Rule 3

According to RDC 751/2022, Annex I:

"All non-invasive devices consisting of a substance or mixture of substances intended for use in vitro in direct contact with human cells, tissues or organs removed from the human body or used in vitro with human embryos, prior to their implantation or administration into the body, are classified in class IV."

Result - Class I (Mechanical barrier):

Result

Classification: Class I Applicable rule: Rule 4

According to RDC 751/2022, Annex I:

"All non-invasive devices that come into contact with injured skin or mucous membrane are classified: a) in class I, if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates"

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