GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYabove for Class IIa (i.e. Annex IV, V or VI). Once the manufacturer has received certification from theNotified Body he may CE mark his products and place them on the market.Class IIIClass III controls are similar to those for Class IIb devices but additionally require the manufacturer tosubmit the design dossier to the Notified Body for approval under Annex II and do not allow the AnnexIII/Annex VI option. Once the manufacturer has received certification from the Notified Body he may CEmark his products and place them on the market.Flowcharts 1 and 2 at the end of this guide illustrate the conformity assessment routes.CONFORMITY ASSESSMENT PROCEDURES IN DIRECTIVE 90/385/EECIn the case of custom-made devices, the manufacturer must draw up the declaration provided for in Annex6 of the Directive (Statement concerning devices intended for special purposes) before placing eachdevice on the market. There is no involvement of a Notified Body and the CE marking is not affixed to thedevices.In the case of devices other than those which are custom made or intended for clinical investigations, themanufacturer must use, in order to affix the CE marking at his own choice:a. the procedure relating to the EC declaration of conformity set out in Annex 2 of the Directive(Complete quality assurance system), or:b. the procedure relating to EC type examination as set out in Annex 3 of the Directive, followed by:• the procedure relating to EC verification set out in Annex 4 of the Directive, or• the procedure relating to EC declaration of conformity to type set out in Annex 5 of theDirective.In each of these procedures a Notified Body is involved, either to approve the manufacturer’s qualitysystem (Annex 2 en Annex 5) or to evaluate and test the product and product type (Annex 3 and Annex4).Flow chart 3 at the end of this guide illustrate the conformity assessment routes.INFORMATION SUPPLIED BY THE MANUFACTUREREach device must be accompanied by the information needed to use it safely and to identify themanufacturer, taking account of the training and knowledge of the potential users.This information comprises the details on the label and the data in the instructions for use.As far as practicable and appropriate, the information needed to use the device safely must be set out onthe device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. Ifindividual packaging of each unit is not practicable, the information must be set out in the leaflet suppliedwith one or more devices.Instructions for use must be included in the packaging for every device. By way of exception, no suchinstructions for use are needed for medical devices in Class I or IIa if they can be used safely without anysuch instructions.Where appropriate, this information should take the form of symbols. Any symbol or identification colourused must conform to the harmonized standards. In areas for which no standards exist, the symbols andcolours must be described in the documentation supplied with the device.
Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYTHE LABELThe label must bear the following particulars:(a)(b)(c)(d)(e)(f)(g)(h)(I)(j)(k)(l)(m)(n)the name or trade name and address of the manufacturer. For devices imported into theCommunity, in view of their distribution in the Community, the label, or the outer packaging, orinstructions for use, shall contain in addition the name and address of the authorizedrepresentative of the manufacturer established within the Community or of the importerestablished within the Community, as appropriate;the details strictly necessary for the user to identify the device and the contents of the packaging;where appropriate, the word ‘STERILE’;Where appropriate, the batch code preceded by the word ‘LOT’, or the serial number;Where appropriate, an indication of the date by which the device should be used, in safety,expressed as the year and month;Where appropriate, an indication that the device is for single use;If the device is custom-made, the words ‘custom-made device’;If the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;any special storage and/or handling conditions;Any special operating instructions;Any warnings and/or precautions to take;Year of manufacture for active devices other than those covered by (e). This indication may beincluded in the batch or serial number;Where applicable, method of sterilization;In the case of a device within the meaning of Article 1(4a) of Directive 93/42/EEC, an indicationthat the device contains a human blood derivative.If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it onthe label and in the instructions for use.Wherever reasonable and practicable, the devices and detachable components must be identified, whereappropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by thedevices and detachable components.INSTRUCTIONS FOR USEWhere appropriate, the instructions for use must contain the following particulars:(a)(b)(c)(d)(e)The details referred to in Section E.1 above, with the exception of (d) and (e);The performances intended by the manufacturer and any undesirable side effects;if the device must be installed with or connected to other medical devices or equipment in order tooperate as required for its intended purpose, sufficient details of its characteristics to identify thecorrect devices or equipment to use in order to obtain a safe combination;all the information needed to verify whether the device is properly installed and can operatecorrectly and safely, plus details of the nature and frequency of the maintenance and calibrationneeded to ensure that the devices operate properly and safely at all times;Where appropriate, information to avoid certain risks in connection with implantation of the device;
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