Definition of Medical Devices

Carlos A. Valverde, MD, MSc

What Is a Medical Device?

Medical devices are essential tools in modern healthcare, playing a critical role in diagnosis, prevention, monitoring, treatment, and alleviation of diseases. These products range from simple instruments like thermometers and surgical gloves to complex technologies such as implantable defibrillators and diagnostic systems, including Magnetic Resonance Imaging (MRI).

Medical devices are regulated by national and international authorities to ensure their safety and effectiveness. While each regulatory agency provides its own legal definition, all aim to distinguish medical devices from pharmaceuticals by their primary mode of action—which is typically mechanical, physical, or structural, rather than pharmacological, immunological, or metabolic.

🔹 FDA (United States)

Section 201(h) of the Food, Drug, and Cosmetic Act (21 USC 321(h)) provides that the term "device" means:

"An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(B) 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

(C) 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 its primary intended purposes.)."

🔹 EMA (European Union)

The European Medicines Agency (EMA), under Regulation (EU) 2017/745 (Medical Device Regulation - MDR), defines a medical device as:

"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 products shall also be deemed to be medical devices:

• devices for the control or support of conception;

• products specifically intended for the cleaning, disinfection or sterilisation of devices"

The MDR also emphasizes software and connected technologies as medical devices when intended for medical purposes.

🔹 INVIMA (Colombia)

The National Institute for Food and Drug Surveillance (INVIMA) defines a medical device as:

"Any instrument, apparatus, machine, software, biomedical equipment or other similar or related article, used alone or in combination, including its components, parts, accessories and computer programs involved in its correct application, intended by the manufacturer for use in human beings in the following cases:

• Diagnosis, prevention, monitoring, or alleviation of a disease (e.g., an echocardiograph, endoscope, laryngoscope, etc.).

• Diagnosis, prevention, monitoring, treatment, alleviation, or compensation of an injury or impairment (e.g., a defibrillator, speculum, sutures, laparoscope, etc.).

• Investigation, replacement, modification, or support of an anatomical structure or a physiological process (e.g., pacemakers, heart valves, hip prostheses, etc.).

• Diagnosis of pregnancy and control of conception (e.g., condoms).

• Care during pregnancy, birth, or after, including newborn care (e.g., forceps, pediatric incubators, ultrasound machines, etc.).

• Products for the disinfection and/or sterilization of medical devices (disinfectants)

INVIMA classifies medical devices into Classes I, II, and III based on their risk, aligning closely with international frameworks.

✅ Why Definitions Matter

Understanding how regulatory agencies define medical devices is fundamental for manufacturers, researchers, and innovators. The classification of a product as a medical device impacts the different stages of medical devices from the regulatory strategy and clinical trial requirements to labeling, marketing, and post-market surveillance.

References

1.           Food and Drug Administration. Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff [Internet]. 2017. Available from: http://www.fda.gov/CombinationProducts/default.htm.

2.           The European Parliament and the Council. Regulation  (EU)  2017/  745  of  The European Parliament and the Council  -  of  5  April  2017  -  on  medical  devices,  amending  Directive 2001/  83/  EC,  Regulation (EC) No 178/  2002  and  Regulation (EC) No 1223/  2009  and  repealing  Council  Directives  90/  385/  EEC  and  93/  42/  EEC. 2015 Apr.

3.           Ministerio de la Protección Social. Republlica de Colombia. Decreto Número 4725 DE 2005. 2005.