Medical Devices
Medical Device Coordination Group Document MDCG 2021- 24
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Practical issues of classification / Explanation of special concepts
Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
document covering the borderline between medical devices and medicinal products.
Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
body temperature measuring device.
Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
less (a frequency of 3 × 10
15
hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.
Rule 11 – Software intended to provide information to inform decisions with diagnosis or therapeutic
purposes or software intended to monitor physiological processes.
General explanation of the rule
Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software
to the healthcare decision and the healthcare situation or patient’s condition.
This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub-
rule only applies to software intended for monitoring purposes only).