MDC: Outcome: Group definitions (11)

accessory means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended.

active implantable medical device means an active medical device that is intended by the manufacturer:

1. either:
   1. to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
   2. to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
2. to remain in place after the procedure.

active medical device means:

1. a medical device that is intended by the manufacturer to:
   1. depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
   2. act by converting this energy; but
2. does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software is an active medical device.

implantable medical device means a medical device (other than an active implantable medical device) that is intended by the manufacturer:

1. to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure;
2. to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure;
3. to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure.

intended purpose, of a kind of medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:

1. the information provided with the device;
2. the instructions for use of the device;
3. any advertising material applying to the device;
4. any technical documentation describing the mechanism of action of the device.

joint replacement medical device means an implantable medical device:

1. that is intended by the manufacturer to operate (either alone or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and
2. that (either alone or together with one or more other implantable medical devices):
   1. replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
   2. provides primary fixation to the bone for the replacement articulating surface; or
   3. connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph or and operates as an intrinsic element of the joint replacement;

but does not include an ancillary medical device.

ancillary medical device means an implantable medical device that:

1. consists of screws, plates or wedges;
2. is intended by the manufacturer to be used to:
   1. provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint;
   2. provide bone substitution in relation to, or additional fixation for, any such device;
   3. (iii) otherwise assist any such device;

where the individual requirements of a patient make it appropriate to do so.