GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYTHE MEDICAL DEVICES DIRECTIVEThe second Directive covers most other medical devices, ranging from, for example, first aid bandages,tongue depressors, hip prostheses, X-Ray equipment, ECG and heart valves.THE IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVEThe third Directive covers any medical device which is a reagent, reagent product, calibrator, controlmaterial, kit, instrument, apparatus, equipment or system intended for use in-vitro for the examination ofspecimens, including blood and tissue donations, derived from the human body. Examples of in-vitrodiagnostic devices are blood grouping reagents, pregnancy test kits and Hepatitis B test kits.KEY POINTS IN THE DIRECTIVESCE MARKINGThe CE marking that appears on a medical device or on its packaging means that the device satisfies therelevant essential requirements and is fit for its intended purpose as specified by the manufacturer.Eventually all devices, (except custom-made devices, those intended for clinical investigations anddevices for performance evaluation) whether used in private or public hospitals and nursing homes or soldin retail outlets, will have to carry the CE marking.CLASSIFICATIONThe Medical Devices Directive and the In Vitro Diagnostic Medical Devices Directive include aclassification system whereby the level of regulatory control applied to devices is proportionate to thedegree of risk associated with the device. The strictest controls therefore apply only to high-risk products.THE COMPETENT AUTHORITYThe Competent Authority is the body responsible for implementing the requirements of the Directives ineach Member State. In the UK, the Competent Authority is the Secretary of State for Health acting throughthe MHRA. The Competent Authority's main role is to ensure that manufacturers comply with theRegulations, to evaluate adverse incident reports received from manufacturers, and carry out a pre-clinicalassessment of devices intended for clinical investigation.NOTIFIED BODIESThe Competent Authority is also responsible for designating the independent certification organisations(Notified Bodies) that check that manufacturers of medium and high risk medical devices have followedthe requirements. Once they are satisfied, manufacturers may apply the CE marking to their products andplace them on the market.CLINICAL INVESTIGATIONSThe Directives require all devices intended for clinical investigation in the EU to be formally assessed onthe risks such investigations might pose to the health and safety of patients. For most medical devices(except in-vitro diagnostic devices) manufacturers have to inform the relevant Competent Authority if theyintend to start a clinical investigation at least 60 days before it is due to begin. The investigation may startafter the 60-day period unless the Competent Authority notifies the manufacturer of a decision to thecontrary on grounds of public health.
Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYADVERSE INCIDENT REPORTING (VIGILANCE)Manufacturers are required to report serious incidents to the Competent Authority. Information aboutthese is collected and evaluated centrally and, where necessary, made available to other Member States.The overall aim of the system is to improve the safety of patients, users and others by trying to preventincidents similar to those reported occurring elsewhere in the Union.FIELD OF APPLICATION - DEFINITIONSDIRECTIVE 93/42/EEC ON MEDICAL DEVICESDEFINITION OF "MEDICAL DEVICES"a) devices - accessoryThe definition of the term "medical device" together with the definition of "accessory" is determinantfor the delimitation of the field of application of Directive 93/42/EEC. A slight difference existsbetween the definition in article 1(2) (a) of Directive 93/42/EEC and in article 1(2) of Directive90/385/EEC.Following the latter directive, accessories are by definition medical devices, whilst following Directive93/42/EEC, a distinction is made between "devices" and "accessories". Therefore within the meaningof Directive 93/42/EEC, accessories are products in their own right and, although being treated asdevices (article 1(1)) do not follow, as a general rule, the classification of related devices inconjunction with which they are used.Accessories are therefore following Directive 93/42/EEC to be classified in their own right.b) medical purposeMedical devices are defined as articles which are intended to be used for a medical purpose. Themedical purpose is assigned to a product by the manufacturer. The manufacturer determines throughthe label, the instruction for use and the promotional material related to a given device its specificmedical purpose. As the directive aims essentially at the protection of patients and users, the medicalpurpose relates in general to finished products regardless of whether they are intended to be usedalone or in combination. This means that the protection ensured by the directive becomes valid forproducts having a stage of manufacture, where they are supplied to the final user.Following this concept, raw materials, components or intermediate products are as such normally notmedical devices. Such raw materials may need to present properties or characteristics which aredeterminant for the safety and quality of finished devices. It is therefore the responsibility of themanufacturer of finished devices to select and control by adequate means his raw materials orintermediate products (see Annex I, section 7.1; Annex II, section 3.2; Annex V, section 3.2 ofDirective 93/42/EEC)Spare parts supplied for replacement of existing components of a device, the conformity of which hasalready been established, are not medical devices. If spare parts, however, change significantly thecharacteristics or performances of a device with regard to its already established conformity, suchspare parts are to be considered as devices in their own right.c) customizingThe concept of "finished device" does not imply that a device when reaching the final user is alreadyin a state ready for use. Prior to use further preparatory processing, preparation, configuration,installation, assembling, adaptation or fitting to the needs of the user or patient may be required.Examples :
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