The Medical Devices Directive (93/42/EEC)

The Medical Devices Directive (93/42/EEC), along with two associated directives (the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices Directive) cover all medical equipment.

This directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. The Directive excludes any products which come within the scope of one of the other two medical device directives.

The Medical Devices Directive has a very wide scope and it is important to realize that the intended purpose and the way a product is marketed can cause them to be covered or excluded. The Directive defines and applies different administrative requirements to four classifications of medical device. These classifications are based on the risk a device presents to the public, as defined through a series of classification rules.The Directive came fully into force in June 1998 and is enforced in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

Purpose

The Medical Devices Directive was enacted to provide for a harmonised regulatory environment for all medical devices sold within the European Economic Area. All products which fall within the scope of the Directive must meet certain essential safety and administrative requirements and are to be CE marked to show that they comply. Such products may then be freely sold throughout the EEA without being subject to additional national regulations.

Scope

This Directive is one of a suite of three directives which together cover all medical equipment. The associated directives are the Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostic Devices Directive (IVDD).

The Directive defines medical devices as:

“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, or 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.”

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