GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYRULE 10covers active diagnostic devices. They are in Class IIa if they supply energy (other than forillumination) absorbed by the body or if they monitor physiological processes or if they image in vivodistribution of radiopharmaceuticals. They may be in Class IIb if they are used for similar monitoringbut intended specifically for critical situations. Radiological equipment will also generally be in ClassIIb.RULE 11covers all active devices (whether therapeutic or diagnostic in purpose) which administer or removesubstances (including medicines and body liquids). These will be in Class IIa but may be in Class IIbif they carry out their function in a potentially hazardous way.RULE 12covers all other active devices and places them in Class I.d) miscellaneous rules for products which merit a higher classification than they mightotherwise be assignedRULE 13assigns the highest classification (Class III) to devices which incorporate a substance which would beconsidered as a medicinal product if placed on the market separately and that substance liable toassist or enhance the functioning of the device itself. Examples are heparin-coated catheters andbone-cement containing an antibiotic.RULE 14places condoms and other contraceptive devices in Class IIb. All intra-uterine contraceptive devices,however, will be in Class III.RULE 15covers cleaning and disinfecting products specifically designed for use with medical devices. Theywill be in Class IIa, except for contact lens care products which will be in Class IIb.RULE 16covers x-ray film which will be in Class IIa.RULE 17covers devices incorporating animal tissues which have been rendered non-viable and places themin Class III, except where such devices are intended to come into contact with intact skin only whenthey will be governed by other rules.RULE 18covers blood bags and places them in Class IIb.HOW THE PROCESS WILL WORK?It is initially for the manufacturer to determine the classification of his product(s). This will allow him toselect a Notified Body, if required, with the ability to carry out the appropriate conformity assessmentprocedure. It will then be for that Notified Body to confirm the classification arrived at by themanufacturer before embarking upon the process of conformity assessment.
Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYIn the event that the manufacturer and the Notified Body cannot agree on the classification eitherparty can refer the matter for a decision to the Competent Authority which designated the NotifiedBody. If doubt still exists the EC Commission, acting in conjunction with a RegulatoryCommittee composed of experts from the Member States may be approached for a ruling. Similarly,the EC Commission, in conjunction with the Regulatory Committee, may adapt the rules if experienceshows this to be necessary.CONFORMITY ASSESSMENT PROCEDURESOVERVIEWIn general terms, a manufacturer wishing to place his medical devices on the market must:• if appropriate, assign his devices to one of the relevant risk categories defined in the Directive;• ensure that the device meets the "essential requirements" specified in Annex I of either Directive;• follow the appropriate conformity assessment procedure;• if appropriate, ensure that an independent body (called a “Notified Body”) is involved in theconformity assessment procedure.MANUFACTURERThe manufacturer is defined as:(a)(b)the “person with responsibility for the design, manufacture, packaging and labeling of a devicebefore it is placed on the market under his own name, regardless of whether these operations arecarried out by that person himself or on his behalf by a third party;” ora person who “assembles, packages, processes, fully refurbishes and/or labels one or more readymade products and/or assigns to them their intended purpose as devices with a view to their beingplaced on the market under his own name.” This does not apply to a person who assembles oradapts devices already on the market to their intended purpose for an individual patient.AUTHORISED REPRESENTATIVEManufacturers who do not have a registered place of business in the EC must designate an authorisedrepresentative to perform certain obligations (e.g. to make certain documentation available on request)and may designate an authorised representative to perform other substantive obligations.NOTIFIED BODYA "Notified Body" is an organisation which the Competent Authority designates to carry out certain tasks inrespect of the conformity assessment procedures described in the Annexes to the Directives. A notifiedbody must be qualified to perform all the functions set out in any Annex for which it is designated. Thetasks which a notified body can carry out may be restricted by the Competent Authority. The activities ofnotified bodies are regularly monitored.Manufacturers are free to apply to any notified body in the EU designated to carry out the desiredconformity assessment procedure, regardless of which Member State that notified body is designated in.Manufacturers are required to inform their notified body of changes to their product ranges and qualitysystem. In cases where design or type examination has been carried out by the notified body themanufacturer is required to notify them of changes to the design, as well as any information they have onchanges to the pathogen and markers of infection to be tested.
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GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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