MDC: Group? (4)

The classification for some medical devices is pre-determined. Check to see if your device is in any of the following groups:

Group A

This group includes medical devices that contain:

• a medicine that acts on the patient to provide a secondary effect in addition to the device's main intended purpose (like drug coated stents), this does not include devices whose main intended purpose is to deliver a medicine (like syringes or infusion pumps)
• non-viable animal tissues or cells or derivatives (other than hair or wool or sintered hydroxyapatite or tallow derivatives), except if the device is only intended to contact intact skin. Some examples include wound dressings with collagen and heart valves with animal tissue leaflets

If Group A is applicable, select this option even if your medical device is also listed in another group.

Group B

This group includes medical devices that are:

• breast implants
• knee, hip, or shoulder joint replacement implants
• motion‑preserving device for the spine (such as a spinal disc replacement)
• intended for contraception or prevention of sexually transmitted diseases and that are implantable or invasive for long-term use
• active implantable medical devices
• implantable accessories to active implantable medical devices
• active devices that are intended to control, monitor or directly influence the performance of an active implantable medical device 

Group C

This group includes medical devices that are:

• blood bags, including those that contain an anti-coagulent
• ancillary medical devices for use in joint replacement surgery
• intended for disinfecting, cleaning, rinsing or hydrating contact lenses
• intended for disinfecting another medical device
• intended for contraception or prevention of sexually transmitted diseases and that are not implantable or invasive for long-term use
• intended to administer medicines or biologicals by inhalation where
  • the mode of action of the device is important to its efficacy and safety of the biological; or 
  • it is intended to treat a life-threatening condition.
• substances or combinations of substances introduced into the human body through a body orifice other than the nasal cavity, or beyond the pharynx in the oral cavity

Group D

This group includes medical devices that:

• record patient images (through a method that relies on energy outside the visible spectrum), or
• are anatomical models (physical or virtual), or
• are intended to be used to administer medicines or biologicals by inhalation that does not treat a life-threatening condition or where mode of action does not affect the efficacy and safety of the biological or medicine, or
• are substances or combinations of substances introduced into the human body through the nasal or oral cavity as far as the pharynx and achieves its purpose in that cavity, or
• are substances or combinations of substances applied to and absorbed by the skin and achieves its intended purpose on the skin, or
• are software, programmable or programmed and used to generate a virtual anatomical model

and are also intended to be used for either or both of the following:

• the diagnosis or monitoring of a disease, injury or disability
• the investigation of the anatomy or of a physiological process.

Group E

This group includes devices that are:

• intended to be used only to clean another medical device (other than contact lenses) by means of physical action
• for export only