Definitions

  • Medical device: any instrument, apparatus, equipment, software, material or other article that is used alone or in combination, including the software specially intended by the manufacturer to be used for diagnostic and/or therapeutic purposes and required for proper function of them, determined by the manufacturer to be used on humans for:

 

  • diagnosis, prevention, monitoring, treatment or alleviation of a disease;
  • diagnosis, monitoring, treatment, alleviation or compensation for a wound or handicap;
  • research into, replacement or changes to the anatomy or a physiological process;
  • managing fertility;

 

and whereby the most significant intended effect in or on the human body cannot be achieved using pharmacological or immunological means or metabolism, but can be supported by these means.

 

  • Attachment: any article that is not a device and is specifically intended by the manufacturer to be used with a medical device to enable the use of this device consistent with the intentions of the manufacturer of the device.

 

  • Active medical device: any medical device, the function of which is dependent on an electrical energy source or another energy source generated directly by the human body or gravity and which functions thanks to the deposition of this type of energy. The medical devices intended to transfer energy, substances or other elements between an active medical device and the patient, without significant changes, are not considered active medical devices.

 

  • Active implantable medical devices (AIMD): any active medical device that is designed to, in whole or in part, to be implanted in a surgical or medical manner in the human body or through a medical procedure in a natural opening, and which is intended to remain in the body after the procedure.

 

  • Custom-made medical devices: any device specially produced by prescription from a qualified physician in which, under their responsibility, the specific features are indicated in the design, and intended exclusively for use in a particular patient.

 

  • Medical devices for in-vitro diagnostics (IVD): any medical device that is a reagent, a reactive product, a calibration material, a control material, a kit, an instrument, a device, equipment or a system that is used separately or in combination and is intended by the manufacturer to be used for in-vitro research of specimens originating from the human body, including donor blood and tissue, exclusively or with the primary purpose of collecting information:

 

  • about a physiological or pathological status;
  • about a congenital deformity;
  • to determine the safety and degree of compatibility with potential recipients;
  • to test the effects of therapeutic measures.

 

  • Recipients for specimens: medical devices, whether or not with vacuum, which are specially intended by the manufacturers to directly contain and conserve specimens originating from the human body intended for in-vitro diagnostics. Recipients for specimens are considered medical devices for in-vitro diagnostics.

 

Products for general laboratory use: these products are not medical devices for in-vitro diagnostics, unless the features of these products indicate that they are specifically intended by the manufacturer to be used for in-vitro diagnostics.

Last updated on 14/02/2019