Rul

Class  I

Class  IIa

Class  IIb

Class  III

non-invasive medical devices

1

if no other rule applies

2

in all other cases

channeling or storing blood, body liquids or tissues, liquids or gases for infusion, administration or intro­duction into the body if they may be connected to an AIMD of class IIa or higher, and if used for storing or channeling blood or other body liquids or storing (parts of) organs or body tissues

3

modifying biological or chemical composition of blood by filtration centifugation or exchanges of gaz or heat

modifying biological or chemical composition of blood

other body liquids or other perfusion liquids

4

contact with injured skin as mechanical barrier, for compression or for absorption of exudates

in all other cases, including intention to manage the micro-environment of a wound

contact with wounds which have breached the dermis and can only heal by secondary intent

invasive medical devices

5

body orifices: transient use and short term use in oral and nasal cavity or ear canal

body orifices: short term use, except oral and nasal cavity or ear canal and long term use in oral and nasal cavity or ear canal and if connected to an AIMD of class IIa or higher

body orifices: long term use, except oral and nasal cavity or ear canal

6

transient use: reusable instruments

transient use: in all other cases

transient use: intended to supply energy (ionizing radiation) and if intended to have a biological effect or to be wholly or mainly absorbed and if intended to administer medicines if this is potentially hazardous

transient use: diagnose, monitor or correct a defect of the heart or CCS through direct contact

7

short term use:

short term use: intended to supply energy (ionizing radiation) and if to undergo chemical change in the body if placed in the teeth and if to administer medicines

short term use: diagnose, monitor or correct a defect of the heart or CCS through direct contact and if used in direct contact with the CNS and if biological effect or if to be wholly or mainly absorbed

8

long term use or implantable: if placed in the teeth

long term use or implantable: all other cases

long term use or implantable: in direct contact with the heart, CCS or CNS and if biological effect or if to be wholly or mainly absorbed and if to undergo chemical change in the body, except if placed in the teeth and if to administer medicines

active medical devices

9

therapeutic device: to administer or exchange energy

therapeutic device: to administer or exchange energy in a potentially hazardous way and if to control or monitor or to directly influence an AIMD in class IIb

10

intended for diagnosis: if to supply energy except for illuminate the body in the visable spectrum and if to image in vivo distribution of radiopharmaceuticals and if to allow direct diagnosis or monitoring of vital physiological processes

intended for diagnosis: if to allow direct diagnosis or monitoring of vital physiological processes with immediate danger (cardiac performance, respiration, CNS activity) and if to emit ionizing radiation including devices which control or monitor or with direct influence  on the performance of such devices

11

intended to administer and/or remove medicines, body liquids or other substances to or from the body

intended to administer and/or remove medicines, body liquids or other substances to/from the body in a potentially hazardous manner

12

all other active devices

special rules

13

devices incorporing as an integral part, a medicinal product which is liable to act on the human body with an anxillary action to the device

14

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

devices used for contraception or the prevention of the transmission of sexually transmitted diseases if implantable or long term invasive

15

devices intended for desinfecting medical devices (this rule is not applicable for cleaning by physical action of devices other than contact lenses)

devices intended for desinfecting, cleaning, rinsing or hydratating contact lenses

16

non-active devices, specifically intended for recording of X-ray diagnostic immages

17

devices manufactured from animal tissues or derivatives rendered non-viable, except if intended to come in contact with intact skin only

18

blood bags