Learn about medical devices

A medical device is a product used for medical purposes in patients, in diagnosis, therapy or surgery[citation needed]. Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means. Medical devices are included in the category: Medical technology.


Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, and blood sugar meters.

The global market of medical devices reached roughly 209 billion US Dollar in 2006 and is expected to grow with an average annual rate of 6–9% through 2010



Definitions
  European Union legal framework and definition

Based on the "New Approach", rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The "New Approach", defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators allowing for the free movement of goods inside the EU.

The core legal framework consists of 3 directives:
Directive 90/385/EEC regarding active implantable medical devices;
Directive 93/42/EEC regarding medical devices;
Directive 98/79/EC regarding in vitro diagnostic medical devices.

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC.

Directive 2007/47/ec defines a medical device as: "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used 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

This includes devices that do 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 government of each Member State is required to appoint a Competent Authority responsible for medical devices. The Competent Authority (CA) is a body with authority to act on behalf of the government of the Member State to ensure that the requirements of the Medical Device Directives are transposed into National Law and are applied. The Competent Authority reports to the Minister of Health in the Member State. • The Competent Authority in one Member State does not have jurisdiction in any other Member State, but they do exchange information and try to reach common positions.

In UK the Medicines and Healthcare products Regulatory Agency (MHRA) acts as a CA, in Italy it is the Ministero Salute (Ministry of Health)[2]

Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark.
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Definition in USA by the Food and Drug Administration

Medical machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that 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 any of 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.