A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery. 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, 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, blood sugar meters, total artificial hearts, fibrin scaffolds, stents and X-ray machines.
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
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.
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:
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.