THE MEDICAL DEVICES DIRECTIVE – 93/42/EEC

One of the “new approach” directives, the European Union’s Medical Devices Directive has been in effect since January 1, 1995, and enforced since June 15, 1998.

This directive applies to any instrument or apparatus, whether used alone or in combination for the purpose of “diagnosis, prevention, monitoring, treatment, alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; or, investigation, replacement, or modification of the anatomy. This directive does not apply to active implantable devices or in-vitro diagnostic devices, which are covered under separate directives. It does, however, include computers and software that are used primarily for medical purposes.

The device or apparatus must meet all specified requirements as they relate to performance, health, and safety. The device must not compromise the health and safety of the patient, the user, or any other persons, and risks must be deemed acceptable when considering the benefits to the patient. The product must meet established requirements regarding safety in design, adequate product marking and instructions of use, compatibility with other materials with which it may come in contact, and protection against contamination from a radioactive, infectious, or microbial source. More details regarding these requirements may be found in Annex I of the Medical Devices Directive.

For the purpose of conformity assessment procedures, the directive groups medical devices into four product classes based on the potential risks associated with the device and its intended purpose. Annex IV of the Medical Devices Directive provides greater detail on how to classify the product and the factors that determine that classification. The classifications, however, are as follows:

Class I: Low Level Risk - the product’s conformity is the manufacturer’s responsibility

Class IIa: Moderate Level Risk – a notified body must be involved during the product’s production stage to ensure compliance

Class IIb: High Risk – a notified body must inspect the design and manufacture of the product to ensure compliance

Class III: High Risk – most critical of devices for which “explicit prior authorization [by a notified body] with regard to conformity is required for them to be placed on the market”