RULE 13 | EXAMPLES | |
All devices incorporating, as an integral part1, a substance which, if used separately, can be considered to be a medicinal product as defined in Article 1 of the Directive 65/65/EEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III . |
- Antibiotic bone cements, condoms with spermicide, heparin coated catheters, endodontic materials with antibiotics - Ophthalmic irrigation solutions principally intended for irrigation, which contain components which support the metabolism of the endothelial cells of the cornea - Dressings incorporating an antimicrobial agent where the purpose of such an agent is to provide ancillary action on the wound |
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Note 1: "Integral part" means that the device and the medicinal substance form one physical unit. |
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Esempi e precisazioni dalla MEDDEV 2.4/1
Qui termina il percorso per la classificazione del dispositivo di tuo interesse. Se vuoi ripercorrere il cammino fatto premi qui; puoi anche tornare all'inizio o uscire. |
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