The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.

1. EU Medical Device Classification
by Easy Medical Device
Medical Device Regulation 2017/745
22
18
Difference of rule number between
MDD 93/42/EC and MDR 2017/745
# of rules
93/42/EC 2017/745
Duration of use
‘Transient’ means normally intended for continuous
use for less than 60 minutes.
‘Short term’ means normally intended for continu-
ous use for between 60 minutes and 30 days.
‘Long term’ means normally intended for continu-
ous use for more than 30 days.
Classification rules
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12
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1
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3
4
5
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8
14
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Non-invasive devices
Non-invasive devices intended for channel-
ing or storing (Which includes now cells)
Non-invasive devices that modify biological or chemical com-
position of blood, body liquids, other liquids and cells.
Non-invasive devices in contact with injured
skin or mucous membrane.
Devices invasive in body orifices
Surgically invasive devices for transient use.
Surgically invasive devices for short term
use.
Surgically invasive devices for long term use and implantable
(including any device administering medicinal products, sur-
gical mesh or spinal disc).
Active therapeutic devices intended to ex-
change or administer energy.
Active devices for diagnosis & monitoring,
emit ionizing radiation.
Software intended to provide information which is used to
take decisions with diagnosis or therapeutic purposes (from
class I to class III)
Active devices intended to administer and/or remove medici-
nal products, body liquids or other substances
All other active devices.
Devices incorporating a medicinal substance
including human blood or plasma
Contraception or prevention of the transmis-
sion of sexually transmitted diseases
Specific disinfecting, cleaning and rinsing
devices
Devices specifically intended for recording of di-
agnostic images generated by X-ray radiation
Devices utilizing non-viable tissues or cells of hu-
man origin or tissues of animal or derivatives
Devices incorporating or consisting of nano-
material
Invasive devices with respect to body orifices to
administer medicinal products by inhalation
Substances or of combinations of substances that are intend-
ed to be introduced into the human body via a body orifice or
applied to the skin and that are absorbed
Active therapeutic devices with an integrated or incorporated
diagnostic function which significantly determines the patient
management
Non-InvasiveDeviceInvasiveDeviceActiveDevice
ActiveDeviceSpecialRules
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