Medical Device Classification PDF

3. Medical Device Classification 3.3 Medical device Product Code AN: Anesthesiology (Other specialties: Cardiovascular, Clinical Chemistry, Dental, E.N.T., Gastroenterology & Urology, General Hospital, Hematology, Immunology, Microbiology, Neurology, Ob/Gyn, Ophthalmic, Orthopedic, Pathology, Ph...

3. Medical Device Classification 3.3 Medical device Product Code AN: Anesthesiology (Other specialties: Cardiovascular, Clinical Chemistry, Dental, E.N.T., Gastroenterology & Urology, General Hospital, Hematology, Immunology, Microbiology, Neurology, Ob/Gyn, Ophthalmic, Orthopedic, Pathology, Physical Medicine, Radiology, General & Plastic Surgery, Clinical Toxicology. The remaining fields can be found in the referenced website address in the footnote below. https://www.fda.gov/medical-devices/classify-your-medical-device/download-product- code-classification-files#description 3. Medical Device Classification 3.3 Medical devices risk classification rules As we mentioned earlier, different countries have different regulations regarding how medical devices are classified. For instance, according to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. Similar to the FDA, Class III devices of the CE hold the highest risk. 1) Interpretation (Duration of Use) ✓ a medical device is intended for transient use if the manufacturer intends the device to be used continuously for less than 60 minutes. ✓ a medical device is intended for short-term use if the manufacturer intends the device to be used continuously for at least 60 minutes but not more than 30 days. ✓ a medical device is intended for long-term use if the manufacturer intends the device to be used continuously for more than 30 days. 3. Medical Device Classification 3.3 Medical devices risk classification rules 2) Rules for classifying non-invasive medical devices A non-invasive medical device is classified as Class I, unless the device is classified at a higher level under another clause of this schedule. a. Non-invasive medical devices intended to channel or store blood, etc. is classified as Class IIa ✓ a non-invasive medical device that is intended by the manufacturer to be used to channel or store blood or body liquids that are to be infused, administered, or introduced into a person; ✓ a non-invasive medical device that is intended by the manufacturer to be used to store an organ, part of an organ, or body tissue, that is to be later introduced into a person; ✓ a non-invasive medical device that is intended by the manufacturer to be used to channel or store a liquid or gas that is to be infused, administered, or introduced into a patient; ✓ a non-invasive medical device that may be connected to an active medical device classified as Class IIa or higher. 3. Medical Device Classification 3.3 Medical devices risk classification rules 2) Rules for classifying non-invasive medical devices b. Non-invasive medical devices intended to modify the biological or chemical composition of blood, etc. ✓ A non-invasive medical device that is intended by the manufacturer to be used to modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, is classified as Class IIb. ✓ (2) Despite subclause (1), if the treatment for which the medical device to which this clause applies is designed consists of filtration, centrifugation, or exchanges of gas or heat, the device is classified as Class IIa. 3. Medical Device Classification 3.3 Medical devices risk classification rules 2) Rules for classifying non-invasive medical devices c. Non-invasive medical devices intended to have contact with injured skin. ✓ a non-invasive medical device that is intended by the manufacturer to be used in contact with injured skin (including a device the principal intention of which is to manage the micro-environment of a wound) is classified as Class IIa. ✓ a medical device to which this clause applies is classified as Class I if it is intended to be used as a mechanical barrier; or for compression; or for the absorption of exudates. ✓ if a device to which this clause applies is intended to be used principally for wounds that have breached the dermis and the wounds can only heal by secondary intent, the device is classified as Class IIb. 3. Medical Device Classification 3.3 Medical devices risk classification rules 3) Rules for classifying invasive medical devices and implantable medical devices a. Invasive medical devices intended to be used by penetration of body orifices. ✓ If a medical device to which this clause applies is not intended to be connected to an active medical device, the following rules apply: ❖ if the device is intended for transient use, the device is classified as Class I: ❖ if the device is intended for short-term use, the device is classified as Class IIa unless the device is intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity, in which case the device is classified as Class I 3. Medical Device Classification 3.3 Medical devices risk classification rules 3) Rules for classifying invasive medical devices and implantable medical devices Invasive medical devices intended to be used by penetration of body orifices. ❖ if the device is intended for long-term use, the device is classified as Class IIb unless the device is intended to be used in the oral cavity as far as the pharynx, or in an ear canal up to the ear drum, or the device is intended to be used in a nasal cavity and the device is not liable to be absorbed by the mucous membrane, in which case the device is classified as Class IIa. ✓ if a medical device to which this clause applies is intended to be connected to an active medical device that is classified as Class IIa or higher, the device is classified as Class IIa. 3. Medical Device Classification 3.3 Medical devices risk classification rules 4) Special rules for classifying active medical devices An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this schedule. a. Active medical devices for therapy. ✓ An active medical device for therapy that is intended by the manufacturer to be used to administer energy to a patient, or exchange energy to or from a patient, is classified as Class IIa. ✓ if a device referred to in subclause (1) is of a kind such that the administration or exchange of energy occurs in a potentially hazardous way, having regard to the nature, density and site of application of the energy, the device is classified as Class IIb. ✓ An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active medical device for therapy of the kind referred to in subclause (2) is classified as Class IIb. 3. Medical Device Classification 3.3 Medical devices risk classification rules 4) Special rules for classifying active medical devices An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this schedule. b. Active medical devices for diagnosis. ✓ A medical device to which this clause applies is classified as Class IIa if ❖ the device is intended by the manufacturer to be used to supply energy that will be absorbed by a patient's body (other than a device that is intended only to illuminate the patient's body in the visible spectrum; which is classified as Class I); ❖ the device is intended by the manufacturer to be used to image in vivo distribution of radiopharmaceuticals in a patient; ❖ the device is intended by the manufacturer to be used to allow direct diagnosis or monitoring of vital physiological processes of a patient 3. Medical Device Classification 3.3 Medical devices risk classification rules 4) Special rules for classifying active medical devices An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this schedule. b. Active medical devices for diagnosis. ✓ A medical device to which this clause applies is classified as Class IIb if ❖ the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system); ❖ the device is intended by the manufacturer to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology; ❖ (c) the device is intended by the manufacturer to be used to control or monitor, or directly influence 3. Medical Device Classification 3.3 Medical devices risk classification rules 4) Special rules for classifying active medical devices An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this schedule. c. Active medical devices intended to administer or remove medicines, etc, from patient's body. ✓ An active medical device that is intended by the manufacturer to be used to administer medicine, body liquids, or other substances to a patient, or to remove medicine, body liquids, or other substances from a patient, is classified as Class IIa. ✓ However, if a device referred to in subclause (1) is of a kind such that the administration or removal of the medicine, body liquids, or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient's body concerned, and the characteristics of the device, the device is classified as Class IIb. 3. Medical Device Classification 3.3 Medical devices risk classification rules 5) Special rules for classifying particular kinds of medical devices Presentation ?!