AI Algorithms as Medical Devices 

Following up on my last article which focused on the application of AI in Health research (Titled: Horizon Europe embraces Artificial Intelligence in Health Research) I have decided to focus on where AI Algorithms are considered as medical devices and thus will be regulated under the new EU’s Medical Device Regulations.      

Medical devices and software/AI as medical device are regulated under the EU’s new Medical Device Regulations.  The Medical Devices Regulation (EU) 2017/745 is known as the MDR, and the In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746 is known as the IVDR.  Since entering into force all new medical devices used in the EU will be obligated to comply with these regulations. In recent years there has been a significant growth in the use of AI and software in health care and medical devices.  However, many developers don’t realise that their technologies are now exposed to the new medical device regulations.    

So what constitutes a Medical Device?

This is defined in the scope of the MDR and IVDR that determines whether a device or software qualifies as a medical or invitro Diagnostic device.  There are two primary questions: (1) what is the ‘intended purpose’ and (2) what is the ‘specific medical purpose’.      

Intended Purpose and Specific Medical devices are defined as follows:    

• ‘“Intended purpose” means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the clinical evaluation.    

• If a device is to qualify as either a medical device or IVD, the device must have a ‘specific medical purpose.’     

To further explain and get more precise on this, you need to take a closer look at the extracted text below from MDR 2017/745 and IVDR (EU) 2017/746.      

EU definitions of medical and in vitro diagnostic devices    

Medical Device Regulation (EU) 2017/745 Article 2(1)  

“Medical device” means 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

• 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…    

In Vitro Diagnostic Device Regulation (EU) 2017/746 Article 2(2)   

“In vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:   

(a) concerning a physiological or pathological process or state   

(b) concerning congenital physical or mental impairments   

(c) concerning the predisposition to a medical condition or a disease  

(d) to determine the safety and compatibility with potential recipients   

(e) to predict treatment response or reactions   

(f) to define or monitoring therapeutic measures…    

In Summary  

If a technology, software, algorithms or AI falls under any of criteria laid out in the MDR and IVDR definitions you fall under the new EU’s medical device regulations and you will need to apply for regulatory approval.             

Find out More 

Here are the direct links to the Medical Device Regulations   

• The Medical Devices Regulation (EU) 2017/745   

• In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746  

National advice and support can be found on Health Products Regulatory Authority (HPRA) website Medical Devices (hpra.ie)