Is dental software considered as a medical device?

1. Is dental software considered as a medical device?

According to the Medical device regulation MDR 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
• the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations
• and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

So if you can define your software within this explanation, then it is a medical device. Each medical device must have the proper classification, and classification is determined by rules The rule that is applicable for software is Rule 11 which states the following:

Rule 11

Software intended to provide information which is used to make 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 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.

For more information, please see the following:

• EU MDR Annex 8 – classification rules https://advisera.com/13485academy/mdr/classification-rules/

2. If yes do we need to approach Health Canada for Licensing as a medical device?

Yes, each medical device, regardless of classification, must be registered in the local authority for medical devices, in your case Health Canada.