Essentials of European Medical Device Regulatory Affairs

Concept of Time • Application quick, but in situ for longer e.g. cream • Continuous use: uninterrupted actual use of the device for the intended purpose. • However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device

Ref: Directive 93/42/EEC Annex IX Sect 2.6 Chapter II

57

Active Medical Device • Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. • Hearing aids, TENs machines, light boxes to treat SAD • Stand alone software is considered to be an active medical device. Ref: Directive 93/42/EEC Annex IX Sect 1.4 An active non implantable regulated by this directive. Active implantable regulated by Directive 90/385/EEC

MEDDEV 2.1/6 Guidance on software (what is and what is not a medical device)

58