What is a Medical Device?

The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly.

An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries.

Medical device definition in Australia.

According to the Therapeutic Goods Act 1989, a medical device is:

                     (a)  any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

                              (i)  diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

                             (ii)  diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

                            (iii)  investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;

                            (iv)  control or support of conception;

                             (v)  in vitro examination of a specimen derived from the human body for a specific medical purpose;

                            and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

                    (aa)  any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection (2A); or

                   (ab)  any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection (2B); or

                     (b)  an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or (ab); or

                     (c)  a system or procedure pack.

Medical device definition in Brazil.

Brazilian Health Regulatory Agency (ANVISA) defines medical devices as

“Health products, such as equipment, apparatus, material, item or system with a medical, dental, or laboratory use or application for prevention, diagnosis, treatment, rehabilitation and that does not use contraception and pharmacological, immunological or metabolic means to perform the main function in humans, but can be assisted in their functions by such means.

Medical device definition in Canada.

As per Food & Drugs Act, a medical device is defined as,

Device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in

• diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
• restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
• diagnosing pregnancy in human beings or animals,
• caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
• preventing conception in human beings or animals.

However, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal; (instrument).

Medical device definition in China

Medical devices are regulated in China using State Council Order Number 739. As per Order Number 739,

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used in the human body, including required computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:

• Disease diagnosis and prevention
• Diagnosis, monitoring, treatment, mitigation or functional compensation of injury.
• Inspection, replacement, adjustment or support of physiological structure or physiological process.
• Life support or maintenance;
• Pregnancy control.
• To provide information for medical or diagnostic purposes by examining samples from humans.

Medical device definition in Europe

Earlier, Medical Device Directives (MDD) were employed to govern medical devices. As per Council Directive 93/42/EEC (MDD), a medical device is:

‘Medical device’ means any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment, or alleviation of disease,
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• Investigation, replacement, or modification of the anatomy or of a physiological process,
• Control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

A medical device under the latest EU Medical Device Regulations 2017/745 (MDR) is defined as:

‘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.

The following group of products are also considered as a medical device under MDR.

• Devices for the control or support of conception.
• Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Medical device definition in India

CDSCO  governs medical devices in India. The definition of a medical device in India is as follows.

“Medical Device” means, –

(A)substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i),

(B)substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii),

(C)devices notified from time to time under sub-clause (iv)

of clause (b) of section 3 of the Act.

Medical device definition in Japan.

A medical device in Japan is defined per PMD Act as,

The term “medical device” as used in this Act refers to appliances or instruments, etc. which are intended for use in the diagnosis, treatment, or prevention of disease in humans or animals, or intended to affect the structure or functioning of the bodies of humans or animals (excluding regenerative medicine products), and which are specified by Cabinet Order.

Medical device definition in Saudi Arabia

Medical devices in Saudi Arabia are defined in Medical Devices Interim Regulation as follows:

Medical device: means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

1. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
2. Diagnosis, prevention, monitoring, treatment or alleviation of disease,
3. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
4. Investigation, replacement, modification, or support of the anatomy or of a physiological process,
5. Supporting or sustaining life,
6. Control of conception,
7. Disinfection of medical devices,
8. Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

B. which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Medical device definition in Switzerland

As per Swiss MedDO,

Medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other objects:

a. that are intended by their manufacturer for use in human beings;

b. that do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which action can be assisted by such means; and

c. that serve to fulfil one or more of the following specific medical purposes either alone or in combination:1.

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

2. diagnosis, monitoring, treatment, alleviation or compensation of injuries or handicaps,

3. investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition,

4. acquisition of information by means of in vitro investigation of samples obtained from the human body, including donated organs, blood or tissue.

2 Medical devices also include:

a. contraceptive or fertility-enhancing products;

b. items intended specifically to clean, disinfect or sterilise the devices listed in Article 1, paragraph 1 and in paragraph 1 of this Article.

Medical device definition in the United Kingdom (UK)

UK Medical Devices Regulations 2002 defines a medical device as the following.

“Medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—

(a)is intended by the manufacturer to be used for human beings for the purpose of-

(i)diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii)diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii)investigation, replacement or modification of the anatomy or of a physiological process, or

(iv)control of conception; and

(b)does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

Medical device definition in the United States of America (USA)

To define a medical device, one must refer to the various regulations. This article combines all standard definitions of a medical device.

In the US, a medical device is defined by FDA as:

• “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Medical Device Definitions: A Comparison

Let’s compare the definitions to understand what is included in each country’s term ‘medical device’.

The table below shows the product types and countries that include and exclude the product type in the definition of the medical device.

FAQs

Why are medical devices defined in every regulation?

Medical devices must be defined because each country has its own classification rules. According to the definition provided, some may not fall under the scope of a medical device. Manufacturers must first look into the definition before classifying the medical device. Anyone must first begin with definitions before diving deep into regulations. Most regulations have the definitions initially, whereas countries like Australia have it mentioned near the end of regulations.

If my product is classified as a device in country A, will it be the same everywhere?

Most countries have similar device definitions. However, it is essential to go through the regulations of the respective country you decide to market in. This will define the exact medical device for the specific country.

Does the classification of the product differ the same as variations in definitions?

Each country’s classification rules must be followed where the device is subjected to.