Rule 13. All devices incorporating, as These medical devices incorporate medicinal an integral part, a substance which, if substances in an ancillary role. used separately, can be considered to be Examples: antibiotic bone cements; a medicinal product, and which is liable catheters; wound dressings incorporating to act on the human body with action antimicrobial agents to provide ancillary action ancillary to that of the devices, are in on the wound; blood bags incorporating an Class D. NOTE: In some jurisdictions such products: are considered to be outside the scope of the medical device definition; may be subject to different controls. All devices manufactured Example: porcine heart valves. Rule 14. from or incorporating animal or human NOTE: In some jurisdictions such products: cells/tissues/derivatives thereof, whether viable or non-viable, are considered to be outside the scope of the are in Class D, medical device definition; may be subject to different controls. unless such devices are manufactured Examples: leather components of orthopaedic from or incorporate non-viable animal appliances. tissues or their derivatives that come in contact with intact skin only in which case they are in Class A. All devices intended Example: desk-top sterilisers for use with dental Rule 15. specifically to be used for sterilising or instruments. disinfecting medical devices are in Class B. unless they are disinfectant solutions or Examples: solutions intended to be used for the washer-disinfectors intended disinfection of medical devices without further specifically for invasive medical processing (for example in a steriliser) including devices, as the end point of processing, those where the infective agent is a prion; in which case they are in Class C; or washer-disinfector equipment specifically for disinfecting an endoscope or another invasive device. unless they are intended to clean medical devices by means of physical action only, in which case they are in Class A.
Rule 13. All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, and which is liable to act on the human body with action ancillary to that of the devices, are in Class D. These medical devices incorporate medicinal substances in an ancillary role. Examples: antibiotic bone cements; catheters; wound dressings incorporating antimicrobial agents to provide ancillary action on the wound; blood bags incorporating an NOTE: In some jurisdictions such products: are considered to be outside the scope of the medical device definition; may be subject to different controls. Rule 14. All devices manufactured from or incorporating animal or human cells/tissues/derivatives thereof, whether viable or non-viable, are in Class D, Example: porcine heart valves. NOTE: In some jurisdictions such products: are considered to be outside the scope of the medical device definition; may be subject to different controls. unless such devices are manufactured from or incorporate non-viable animal tissues or their derivatives that come in contact with intact skin only in which case they are in Class A. Examples: leather components of orthopaedic appliances. Rule 15. All devices intended specifically to be used for sterilising or disinfecting medical devices are in Class B. Example: desk-top sterilisers for use with dental instruments. unless they are disinfectant solutions or washer-disinfectors intended specifically for invasive medical devices, as the end point of processing, in which case they are in Class C; or Examples: solutions intended to be used for the disinfection of medical devices without further processing (for example in a steriliser) including those where the infective agent is a prion; washer-disinfector equipment specifically for disinfecting an endoscope or another invasive device. unless they are intended to clean medical devices by means of physical action only, in which case they are in Class A.
ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.docx