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Question 2: Legal Understanding

Problem Statement:

When working in MedTech, regulations will accompany you wherever you go. They are the key to ensuring that medical device companies follow the highest of standards when designing and building their solutions, ensuring with it that patients that are exposed to their devices are safe and get the best possible outcome.

This regulated environment requires the ability to correctly understand and assess what regulations are applicable to ideas, or how changes in regulations can affect existing solutions.

To get an understanding on how you would navigate a regulated environment, we will ask you to assess the risk class (I, IIa, IIb, III or not-MD) of the following devices under the MDR (medical device regulation) and explain the reasoning behind your conclusions:

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Solution at a glance

Solution at a glance

Given Name

Is it a Medical Device?

Risk Class

Explanation

Doctolib booking platform

I went through the “

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“ on

Doctolib’s website

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and it describes Doctolib as a platform for booking medical appointments and managing patient-provider communications, but does not position it as a medical diagnostic or treatment tool. Thus, it seems unlikely that the Doctolib platform would fall under the MDR's definition of a medical device.

Neuralink's “Telepathy”

The Neuralink device is intended for long-term use as it remains implanted. Also, the device is surgically invasive, as it penetrates the body during implantation.

Thus, the Neuralink device should be classified as Class III under the MDR.

Bong for medical marijuana

A bong for medical marijuana could potentially fall under the definition of “Medical Device” if it is intended by the manufacturer to be used for the treatment or alleviation of disease or disability. However, this would depend on the specific claims made by the manufacturer about the intended use of the product.

If the manufacturer does not intend for the bong to be used for one of the specific medical purposes listed in the definition, then it’s not-MD.

If a bong for medical marijuana is considered a medical device (based on manufacturer’s intent) under the MDR, the bong could potentially be classified as a Class I device under Rule 1, as it is a non-invasive device and none of the other rules appear to apply.

Robotic arm prosthetic for transhumeral amputations

A robotic arm prosthetic for transhumeral amputations is considered a medical device under the European Union Medical Device Regulation (EU MDR). This is because it is an apparatus intended to be used for human beings for the specific medical purpose of compensating for an injury or disability. The risk classification of this device under the EU MDR would likely be Class IIB or Class III, depending on its specific features and intended use.

If the device is simply intended to replace the function of the missing limb and does not incorporate any medicinal substances or substances that are absorbed by the human body, it would likely be classified as Class IIB.

If the device incorporates a medicinal substance, contains a substance which, if used separately, would be considered a medicinal product, or is composed of substances that are absorbed by the human body, it could be classified as Class III.

Spinning bike for rehab purposes

A Spinning Bike for Rehabilitation is considered a medical device due to its specific intention. As defined by the manufacturer, a spinning bike would be used in the treatment or alleviation of injuries or disabilities, distinguishing it from general fitness or leisure equipment.

In terms of risk classification, this device is likely considered Class I. This is because it is a non-invasive device used for physical conditioning or to alleviate an injury or disability, which are therapeutic purposes.

Mammography machine

A Mammography Machine is classified as a medical device. The reason being that it is an apparatus specifically used for breast imaging to aid in the early detection and diagnosis of breast diseases in women. It lies under the definition of an “active device intended for diagnosis and monitoring”.

The mammography machine is a Class IIB device. This classification is due to its use of ionizing radiation to create images of the breast tissue, which can be used to detect and diagnose conditions such as breast cancer.

ACAT - Steven Hawking’s speech system

The Assistive Context-Aware Toolkit (ACAT) should be considered a medical device under MDR. It is specifically intended to compensate for disabilities, such as restricted speech and typing capabilities, enhancing communication through functionalities like keyboard simulation, word/sentence prediction, and speech synthesis.

ACAT falls under Class I because it is a non-invasive device that does not come into direct contact with the human body.

Toothpaste

A toothpaste, if specifically intended by the manufacturer for a medical purpose, could potentially be classified as a medical device. However, this would depend on the specific claims made by the manufacturer about the intended use of the product.

In general toothpaste cannot be considered a medical device as it is typically used for cleaning and maintaining the health of teeth. This doesn’t fall directly under the specific medical purposes.

If a toothpaste is considered a medical device (based on manufacturer’s intent) under the MDR, it could be classified as a Class I device as it is a non-invasive device and used transiently.

AI for breast cancer prevention

An AI system for breast cancer prevention is considered a medical device as it is a software specifically intended for the prevention, diagnosis, and monitoring of breast cancer.

In terms of risk classification, the AI system could potentially be classified as either a Class IIA or Class IIB device under MDR:

If the software provides information used to make decisions with diagnostic or therapeutic purposes, such as analyzing mammograms and providing a risk assessment that aids doctors in making decisions about further diagnostic tests, and if these decisions do not have the potential to cause serious deterioration in a person’s health or a surgical intervention, then it would likely be classified as Class IIA.

If the AI system provides information used to make decisions that could have a serious impact on a patient’s health, such as determining the need for preventative surgery, it could potentially be classified as a Class IIB device.

Skin cancer tracking app

The skin cancer tracking app is considered a medical device as it’s a software intended for the specific medical purpose of tracking skin moles/lesions, aiding in the early detection of skin cancer.

Risk classification:

If the app is designed to monitor physiological processes, such as using image processing algorithms to assess scanned moles and evaluate the probability that the scanned mole is a melanoma for early diagnosis of skin cancer, or if it’s a non-invasive device intended to administer medicinal products by inhalation, then it would be classified as Class IIA.

If the app is intended for monitoring vital physiological parameters, where the nature of variations of those parameters could result in immediate danger to the patient then it would be classified as Class IIB.

There are no rows in this table

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Assumption:

I’m assuming that the audience is familiar with the MDR, hence will not delve into explaining the regulation itself.

Approach Outline:

I will approach this problem in a two-step process:

Step 1

Firstly, I will determine whether the provided example meets the criteria to be classified as a "Medical Device" under Medical Device Regulation (MDR) law, providing rationale for the decision.

Step 2

If the example falls within the definition of a "Medical Device," I will proceed to assess its risk classification (I, IIa, IIb, III, or not-MD) under the Medical Device Regulation (MDR). I will then elucidate the reasoning behind my conclusions

Solution:

1. Doctolib booking platform

1. Overview

Doctolib is a service that allows users to quickly find and book appointments with healthcare practitioners or pharmacies near their location.

It provides access to a wide community of practitioners and helps users manage their health and that of their loved ones securely through features like accounts, documents, and appointments.

The core functionality appears to be around scheduling, messaging, and administrative tasks - rather than providing any direct medical diagnosis, monitoring, or treatment capabilities.

Under “Terms of service” on Doctolib’s website, there's no mention of Doctolib being registered or certified as a medical device under the MDR.

Additionally, it aims to prevent diseases by providing health awareness messages.

2. Is it a Medical Device?

Doctolib is primarily an online appointment booking platform for healthcare services.

It does not directly fit the definition of a medical device. Specifically:

- It does not fall into the categories of instruments, apparatus, appliances, implants, or reagents. - Its primary purpose is not for diagnosis, treatment, or monitoring of medical conditions. - It does not modify anatomy or physiological processes. - It does not provide information through in vitro examination of specimens. - It does not achieve its intended action through pharmacological, immunological, or metabolic means

Therefore, Doctolib does not qualify as a medical device.

2. Neuralink's “Telepathy”

1. Overview: Neuralink is developing an advanced brain-computer interface (BCI) to assist people with medical needs. Key features include:

Implantable and Cosmetically Invisible: The device seamlessly integrates into the user's body.

Functionality: Users can control computers or mobile devices with their neural activity, prioritizing ease of use.

Components: The system includes the N1 Implant sealed in a biocompatible enclosure, a wireless-charged battery, custom chips for signal processing, and ultra-thin threads with 1024 electrodes.

Surgical Robot: A precise surgical robot inserts the threads during implantation.

2. Is it a medical device?

It allows users to control external devices using their neural activity, Neuralink serves a therapeutic purpose.

It directly interacts with the nervous system, making it a medical tool.

Its surgical implantation classifies it as a surgically invasive medical device.

The device carries inherent risks due to its implantable nature and interaction with neural tissue.

Thus, Neuralink satisfies the criteria of a medical device by addressing unmet medical needs, being surgically invasive, and having a clear therapeutic purpose.

3. What is its Risk Class?

Considering the classification rules under the MDR:

- Duration of Use: - The Neuralink device is intended for long-term use as it remains implanted. - It also falls under the category of implantable devices.

- Invasiveness: - The device is surgically invasive, as it penetrates the body during implantation.

Thus, the Neuralink device should be classified as Class III under the MDR.

3. Bong for medical marijuana

Overview:

A "bong for medical marijuana" is a type of smoking device used to consume medical marijuana or cannabis. It typically consists of a water pipe with a bowl at one end where the cannabis is placed and a stem or tube leading down into a chamber of water below. The smoke generated from heating the cannabis is filtered through the water, which cools and purifies it before inhalation. It filters smoke through water for a smoother inhaling experience. It's popular among medical marijuana users for its perceived benefits in delivering therapeutic effects.

2. Is it a medical device under the act?

Now, according to the European Union's Medical Device Regulation (MDR), 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. - 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. Now - A bong for medical marijuana could potentially fall under this definition if it is intended by the manufacturer to be used for the treatment or alleviation of disease or disability. However, this would depend on the specific claims made by the manufacturer about the intended use of the product.

3. If no, then why? If a bong for medical marijuana is not considered a medical device under the MDR, it would be because it does not meet the criteria outlined in the definition. Specifically, if the manufacturer does not intend for the bong to be used for one of the specific medical purposes listed in the definition, it would not be considered a medical device.

4. If yes, how would be it’s Risk class? If a bong for medical marijuana is considered a medical device under the MDR, its could potentially be classified as a Class I device under Rule 1, as it is a non-invasive device and none of the other rules appear to apply. However, the final classification would depend on a detailed analysis of the device and its intended use.

4. Robotic arm prosthetic for transhumeral amputations

1. Overview:

A robotic arm prosthetic for transhumeral amputations is an advanced artificial limb designed for individuals who have had their arm amputated above the elbow (transhumeral amputation). These prosthetic arms utilize robotic technology to mimic the functions of a natural arm, providing users with greater control and functionality.

2. Is it a medical device?

A robotic arm prosthetic for transhumeral amputations falls under this definition as it is an apparatus or appliance intended by the manufacturer to be used for human beings for the specific medical purpose of compensating for an injury or disability1. It is designed to replace the function of a missing limb, thus helping the user to perform daily activities.

3. What is it’s Risk Class?

In the case of a robotic arm prosthetic for transhumeral amputations, it would likely be classified as a Class IIb or III device. Here's why:

1. Invasiveness: A robotic arm prosthetic for transhumeral amputations is an invasive device as it is intended to penetrate the body through a body orifice or the surface of the body. It is also an active device as it depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity to function.

2. Duration of Use: The prosthetic arm is intended for long-term use, typically more than 30 days. This falls under the 'long term' category as defined in the MDR.

3. Potential Risks: The prosthetic arm, especially a robotic one, could pose significant risks if it malfunctions. For example, it could cause physical harm to the user or others, or it could fail to perform its intended function, leaving the user without the use of an arm.

5. Spinning bike for rehab purposes 1. Overview:

A spinning bike for rehabilitation is designed for physical exercise and therapy. It aims to improve cardiovascular fitness, muscle strength, and endurance. Users include individuals recovering from injuries, surgeries, or medical conditions.

2. Is it a medical device? A spinning bike for rehab could be considered a medical device under the EU MDR if it is specifically intended by the manufacturer to be used for the treatment or alleviation of an injury or disability. This would typically be the case if the bike is marketed or sold specifically for rehabilitation purposes, rather than general fitness or leisure. 3. What is it’s Risk Class? A spinning bike for rehab would likely be considered a non-invasive device, as it does not penetrate the body or come into contact with the user’s mucous membranes.

The risk associated with a spinning bike for rehab would likely be considered low. The bike is used for physical conditioning or to alleviate an injury or disability, which are therapeutic purposes. However, it does not diagnose or monitor any physiological conditions, nor does it have any direct impact on the human body other than through mechanical means. Therefore, it does not pose the same level of risk as devices that are invasive or have a biological effect on the body.

Drawing parallels with real-life medical devices in Europe, Class I devices include products such as hospital beds, corrective glasses, and thermometers. These devices pose a low risk to patients and are typically non-sterile and do not have a measuring function. A spinning bike for rehab would likely fall into this category, as it is used for physical conditioning and does not have any diagnostic or therapeutic functions beyond that.

6. Mammography machine

1. Overview:

Mammography machines use low-energy X-rays to examine the human breast, a process known as mammography. This is used to detect and diagnose breast cancer in women who either have no symptoms or who have found a lump during a physical exam.

2. Is it a medical device?

A mammography machine is indeed considered a medical device under the European Medical Device Regulation (MDR). It fits the definition as it is an apparatus used for the specific medical purpose of breast imaging to aid in the early detection and diagnosis of breast diseases in women. It falls under the category of an "active device intended for diagnosis and monitoring" as it is used to supply information for detecting or diagnosing physiological conditions.

3. What is it’s Risk Class?

A mammography machine is an active device intended for diagnosis and monitoring. It uses ionizing radiation to create images of the breast tissue, which can be used to detect and diagnose conditions such as breast cancer. Given the nature of its function and the potential risks associated with the use of ionizing radiation, it is likely that a mammography machine would be classified as a Class IIB medical device.

Specifically, Rule 10 states that active devices intended to emit ionizing radiation for radiodiagnosis and therapeutic radiology are classified as Class IIB

Class IIb devices are medium to high-risk devices that are invasive or emit energy. They are subject to a higher level of regulatory control to ensure their safety and effectiveness.

To further illustrate this, let's consider a similar real-life medical device: the CT scanner. Like a mammography machine, a CT scanner is an active device intended for diagnosis and monitoring. It uses X-rays and computer technology to build a cross-sectional image of the human body. These are used for diagnosing injuries, examining lungs, and internal bleeding. Due to the use of ionizing radiation and the potential risks associated with its use, CT scanners are also typically classified as Class IIB devices.

7. ACAT - Steven Hawking’s speech system 1. Overview:

The Assistive Context-Aware Toolkit (ACAT) was developed by researchers at Intel Labs for Professor Stephen Hawking. It is designed to enhance communication for individuals with restricted speech and typing capabilities by providing functionalities like keyboard simulation, word/sentence prediction, and speech synthesis.

2. Is it a medical device?

According to the European Union Medical Device Regulation (EU MDR), a 'medical device' should be used for medical purposes. These purposes include diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, or compensation for an injury or disability.

Given this definition, ACAT could potentially be considered a medical device under the EU MDR. It is a software intended to be used for the specific medical purpose of compensating for a disability (restricted speech and typing capabilities).

3. What is it’s Risk Class?

The ACAT system does not provide information used to make decisions with diagnosis or therapeutic purposes. It is primarily a communication tool. It also does not monitor physiological processes. It simply interprets physical signals (like cheek movements) to facilitate communication but does not monitor any kind of vital physiological parameters.

The risk classification of ACAT under the EU MDR would likely fall under Class I (low risk). This is because it is a non-invasive device that does not come into direct contact with the human body. It is also not intended to be life-supporting or life-sustaining, or for monitoring physiological processes. Therefore, it does not pose the same level of risk to the patient as some other medical devices.

For example consider the case of the Eye Gaze System, a communication aid similar to ACAT, which is used by people with conditions like Motor Neurone Disease (MND) to communicate and control their environment. This device tracks the user's eye movements to control the system, similar to how ACAT tracks cheek movements. The Eye Gaze System is classified as a Class I medical device in Europe.

8. Toothpaste

1. Overview:

Toothpaste is typically intended for oral hygiene, not for the diagnosis, prevention, monitoring, treatment, or alleviation of any disease.

2. Is it a medical device?

Toothpaste, in general, is used for cleaning and maintaining the health of teeth, which doesn't fall directly under the specific medical purposes mentioned in the MDR definition. Therefore, toothpaste is typically not considered a medical device under the European MDR.

However, there could be exceptions. If a toothpaste is specifically intended by the manufacturer for a medical purpose, such as treating a specific dental disease, and claims are made about its effectiveness for that purpose, it could potentially be classified as a medical device. But such classification would depend on a detailed assessment of the product, its intended use, and the claims made about it.

3. What is it’s Risk Class?

If toothpaste were to be considered a medical device, its risk classification would depend on its intended use, the potential risks associated with its use, and the duration of contact with the human body. Given that toothpaste is typically used transiently (less than 60 minutes) and is non-invasive, it would likely fall under Class I (low risk) if it were to be considered a medical device. This is the same classification as other low-risk devices such as corrective glasses and thermometers.

9. AI for breast cancer prevention

1. Overview:

AI is increasingly being used in the field of healthcare, including for the prevention and early detection of breast cancer. These AI systems can analyze mammogram images and other patient data to identify patterns that may indicate a higher risk of developing breast cancer. Some of these systems are designed to improve the accuracy and efficiency of breast cancer screening, helping to catch the disease at an earlier stage when it is more treatable.

2. Is it a medical device?

An AI system designed for breast cancer prevention would likely fall under the category of ‘software’ and could be considered a medical device if it is intended to be used for the prevention, diagnosis, or treatment of disease. These systems fit the definition of medical devices as they are software's which are intended to be used for the prevention, diagnosis, and monitoring of breast cancer.

3. What is it’s Risk Class?

The rules take into account various factors such as the duration of use (transient, short term, long term), invasiveness, and whether the device is active. An AI system for breast cancer prevention could potentially be classified as a Class IIA or IIB device, depending on its specific functionalities and the potential risks associated with its use. Class IIA:

Under this the software would be intended to provide information which is used to make decisions with diagnosis or therapeutic purposes like analyzing mammograms and provide a risk assessment that aids doctors in making decisions about further diagnostic tests.

If the the decisions based on the information provided by the AI system do not have the potential to cause serious deterioration in a person’s health or a surgical intervention then the class would remain low risk.

Class IIB:

If the AI system is intended to provide information that is used to make decisions that could have a serious impact on a patient’s health such as determining the need for preventative surgery) it could potentially be classified as a Class IIb device.

10. Skin cancer tracking app

1. Overview:

These apps guide users to perform regular self-examinations of their skin, enabling them to track changes over time. Users can take photos of their skin, particularly moles and lesions, and the app will store these images for future reference. Some apps also provide the ability to send these images to a dermatologist for further assessment. These apps are designed to aid in the early detection of skin cancer, as early detection can significantly improve treatment outcomes.

2. Is it a medical device?

According to the European Union Medical Device Regulation (EU MDR), a ‘medical device’ is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used for specific medical purposes. A skin cancer tracking app is a software that is intended to be used for the specific medical purpose of tracking skin moles/lesions, which can aid in the early detection of skin cancer. Therefore, it would be considered a medical device under the EU MDR.

What is it’s Risk Class?

According to the MDR software intended to monitor physiological processes is generally 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.

Class IIA

Physiological Monitoring: If the app is designed to monitor physiological processes, it would typically be classified as Class IIA. For instance, if the app uses image processing algorithms to assess scanned moles and evaluates the probability that the scanned mole is a melanoma for early diagnosis of skin cancer. Non-Invasive Devices: If the app is considered a non-invasive device intended to administer medicinal products by inhalation, it would be classified as Class IIA.

Class IIB

Vital Parameter Monitoring: If the app is intended for monitoring vital physiological parameters, where the nature of variations of those parameters could result in immediate danger to the patient, it would be classified as Class IIB. Therapeutic Devices: If the app controls or monitors active devices intended to emit ionizing radiation for therapeutic purposes, it would be classified as Class IIB. High Intensity Electromagnetic Radiation: If the app controls high intensity electromagnetic radiation emitting equipment intended for skin treatment, it would be classified as Class IIB.

1. Doctolib booking platform

2. Neuralink's “Telepathy”

3. Bong for medical marijuana

4. Robotic arm prosthetic for transhumeral amputations

5. Spinning bike for rehab purposes 1. Overview: