Comment
Author: Admin | 2025-04-28
Added. Note: Blood bags incorporating heparin or other substances such as anticoagulant agents (if used separately) can be considered a medicinal product as covered by Rule 14; these are considered Class III devices.Rule 3: Devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body (Class III) has been added.Rule 4:Where “Injured Skin” is referenced, Mucous Membrane has been added e.g. “in contact with injured skin or mucous membrane”Devices intended for wounds which breach the dermis and heal only by secondary intent (Class IIb) have been added as an optionRule 5: Note that Rules 4, 20 and 21 may also be relevantRule 6: Note that Rule 4 may also be relevantRule 8:Active Implantable Devices or their Accessories (Class III) have been addedSurgical Meshes (Class III) have been added (up-classification from MDD)Partial Joint Replacements (Class III) have been added (up-classification from MDD), except components such as screws, wedges, plates and instruments (Class IIb)Spinal disc replacement or implants in contact with spinal column (Class III) have been added (up-classification from MDD), except components such as screws, wedges, plates and instruments (Class IIb)B. Active Device RulesRule 9:Note that Rule 22 may be relevantDevices intended for controlling, monitoring or directly influencing the performance of active implantable devices (Class III) have been added as an optionDevices intended to emit ionizing radiation for therapeutic purposes and devices which control or monitor such devices, or which directly influence their performance (Class IIb), have been added as an optionRule 10:Devices intended to illuminate the patient’s body in the visible spectrum (Class I) have been added; these devices were previously covered by Rule 13 “All Other Active Devices” (Rule 12 under the MDD)Devices intended for diagnosis in clinical situations where the patient is in immediate danger (Class IIb) have been added as an optionRule 11 is a new Rule specifically relating to Software; depending on the use of the software the classification can range from Class I to Class IIIC. Special RulesRule 14: There is a change of wording in the definition:MDD = Medicinal substance liable to act in an ancillary way on the human bodyMDR = Medicinal substance that has an action ancillary to that of the devicesThe consequence of this change will be
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