What is a medical device?

thermometerFROM contact lenses to cardiac stents, the term “medical device” covers a multitude of items – some familiar to most people, others not.

Some, like a thermometer, are kept in a medicine chest. Others, like a cardiac stent, are implanted in a person’s chest.

A sound definition of a medical device is an object used in or on a body to alleviate, cure or diagnose a medical condition.

The European Union Directive for the registration of medical devices defines a medical device as: “Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap
  • Investigation, replacement or modification of the anatomy or of a physiological process, or
  • 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.”

The medical device industry

contact lensThe global medical technologies and devices market was valued at more than £100 billion in 1999 (Source: EUCOMED European Medical Technologies and Devices Industry Profile 2000) and is composed of a broad array of market segments devoted to the diagnosis and treatment of thousands of diseases and disorders that affect the human body.

The top three markets for medical technologies and devices are the United States, valued at £37 billion, the European Union, valued at £26 billion and Japan, valued at £15 billion.

A key feature of the devices industry is diversity of the products produced. At one end of the spectrum, products are highly invasive and technologically complex. These include electrically active implantable products such as pacemakers, artificial cochlear devices to help restore hearing and implantable neurostimulators used to control pain or incontinence.

Non-active implantable devices include coronary stents for treating vascular disease and knee and hip replacement devices.

At the other end of the spectrum, products include simple consumables such as bandages, dressing and drapes, barrier contraceptives such as condoms and disposable surgical instruments and syringes.

Diagnostic and surgical equipment, such as Magnetic Resonance Imaging (MRI) machines, electrocautery devices and ECG monitors are also classed as medical devices and covered by the same regulatory processes.

The directives to regulate medical devices in the European Union only came into effect in the early 90s. Compare this with the European directives for medicines, which have been around since the mid sixties.

Additionally, the intrinsic nature of the products are based on mechanical, electrical and material engineering principles and are designed to perform certain functions, based on specific performance and safety requirements.

The rapid change in technology and the increasing development of medical devices incorporating new materials, new modes of action and targeting new indications, combined with the increasing requirements for clinical data by the medical device regulators indicate that  this diverse industry will increase.