GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CY• Devices which are used to administer medicinal products (e.g. a syringe marketed empty) arecovered by the relevant Medical Devices Directive. Empty devices (e.g. medicine spoons,droppers etc) or devices which can be refilled with further doses of medication contained withinthe same pack as the medicine are included within this category.• Devices for administering medicinal products where the device and the medicinal product form asingle integral product designed to be used exclusively in the given combination and which are notre-usable (e.g. a syringe marketed pre-filled) or re-fillable are subject to Directive 65/65/EEC. Inaddition, the relevant essential requirements in Annex 1 of the Medical Devices Directive93/42/EEC apply with respect to safety and performance related features of the device (e.g. asyringe forming part of such a product).• Devices incorporating, as an integral part of a substance, which, if used separately, may beconsidered to be a medicinal product and which is such that the substance is liable to act upon thebody with action ancillary to that of the device (e.g. a heparin coated catheter) are subject to theMedical Devices Directive. In addition, the safety, quality and usefulness of the medicinalsubstance must be verified by analogy with the methods in Directive 75/318/EEC concerning thetesting of proprietary medicinal products. Under the classification rules set out in the MedicalDevices Directive (see section C), such a device would fall into class III under rule13. The NotifiedBody carrying out relevant conformity assessment procedures in respect of such a device mustconsult a drug regulatory authority established under Directive 65/65/EEC on those medicinalaspects of the device above.DIRECTIVE 89/336/EEC RELATING TO ELECTROMAGNETIC COMPATIBILITYThe Directive on active implantable medical devices and the Directive on medical devices are "specificdirectives" with regard to Directive 89/336/EEC relating to electromagnetic compatibility (see Article 1(5)AIMD, Article 1(7) MDD).The medical devices directives cover all aspects related to electromagnetic compatibility (immunity andelectromagnetic interference) of medical devices (see AIMD, Annex I, section 8; MDD, Annex I, sections9.2, 11 and 12.5). Thus, in all cases when the medical devices directives are applied, there is no need toapply the Directive 89/336/EEC with regard to EMC aspects.The manufacturer shall indicate in the instructions for use which directives have has been applied. Theparticulars of these directives as published in the Official Journal in conjunction with the relevant Directive,which have been applied shall be given in the instructions for use accompanying the device. The relevantindication should relate to "Directive 90/385/EEC" in the case of application of AIMD, to "Directive93/42/EEC" in the case of MDD and to "Directive 89/336/EEC" in the case of the EMC directive.DIRECTIVE 89/686/EEC RELATING TO PERSONAL PROTECTIVE EQUIPMENTFollowing Article 1(6) of Directive 93/42/EEC, this Directive does not apply to personal protectiveequipment covered by Directive 89/686/EEC relating to personal protective equipmentAs a consequence of this clause a given product is either covered by Directive 89/686/EEC or by Directive93/42/EEC. As a general rule, the principal intended purpose can be established as being the one of amedical device if the product is intended to be used in a medical context with the aim to provide protectionof health and safety for the patient, regardless of whether the product aims simultaneously to protect alsothe user. Where a product is mainly intended to protect the person using it, irrespectively whether in amedical environment or not, it falls under Directive 89/686/EEC.The labeling of the product is crucial for its classification under one or the other Directive.Examples for medical devices