GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYAll such changes need to be approved by the notified body prior to implementation.ESSENTIAL REQUIREMENTSAnnex I of each Directive lists various "essential requirements" with which medical devices must complywith before being placed on the market/put into service. These aim to ensure that devices do notcompromise the health and safety of patients, users, and others, and are designed and manufactured sothat they are suitable for the relevant purpose specified by the manufacturer and achieve theperformances stated by the manufacturer. Not all the essential requirements will apply to all devices and itis for the manufacturer of the device to assess which are appropriate for his particular product. Indetermining this, account must betaken of the intended purpose of the device.CE MARKINGThe CE marking means that a manufacturer is satisfied that his product conforms with the relevantEssential Requirements in the Directives and that it is fit for its intended purpose.The CE marking is seen as a declaration by the manufacturer that the product meets all the appropriateprovisions of the relevant legislation including those relating to safety and where required has beenassessed in accordance with these. The CE marking also means that the product can be freely marketedanywhere in the EU without further control.The following devices are exempt from the CE marking:• custom-made devices• devices undergoing a clinical investigationAlthough custom-made devices are exempt from carrying the CE marking they must conform with all therelevant Essential Requirements. Devices intended for clinical Investigation must also conform with therelevant Essential Requirements as far as possible, and with regard to the aspects under investigationevery precaution must be taken to protect the health and safety of patients.Although third party conformity checks are not required for these products, manufacturers have to draw upa statement of compliance on their own responsibility. This statement is subject to control by the nationalCompetent Authorities. Custom-made devices must be clearly marked as such and all devices for clinicalinvestigation must bear the wording “exclusively for clinical investigation”.Unless there are grounds for suspecting that a device may pose a risk to public health, Member Statesmust not "create any obstacles to the placing on the market or the putting into service of any medicaldevices as defined under the Directive bearing a legitimate CE marking". This means that a CE markeddevice may have access to the whole of theCommunity market and manufacturers are notrequired to comply with any national schemeswhen exporting their devices to other countries inthe EU.The CE marking is reproduced below. It shouldappear on the packaging and on the device itselfwhere this is practicable. Instruction leafletsshould also carry the CE marking. The CEconformity marking shall consist of the initials ‘CE’taking the following form.The grid does not form part of the marking and isfor information only.
Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYIf the marking is reduced or enlarged the proportions given in the above graduated drawing must berespected. The various components of the CE marking must have substantially the same verticaldimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scaledevices.Where a Notified Body has been involved in conformity assessment, the identification number assigned toit by the Commission must be applied below the CE marking.CONFORMITY ASSESSMENT PROCEDURES IN DIRECTIVE 93/42/EECAnnex IX of the Medical Devices Directive sets out the classification rules which manufacturers shoulduse to determine which class a device falls into according to its properties, function and intended purpose(SEE Section C).The level of control applied to devices is designed to reflect the perceived risk associated with the device.Thus the strictest controls are applied only to those devices which present the greatest risk to health orsafety. Devices are assigned to one of four classes: these are Class I for low-risk devices, Classes IIa andIIb for medium-risk devices and Class III for high-risk devices. The conformity assessment routes do notapply to custom-made devices or devices intended for clinical investigation. However the manufacturermust ensure that his products meet the relevant Essential Requirements in the Directives.The conformity assessment routes are as follows:Class IThe manufacturer is responsible for ensuring that his product complies with all the relevant EssentialRequirements of the Directive and must draw up a written statement to this effect(self-declaration). Additionally manufacturers of sterile products and devices with a measuring functionmust apply to a Notified Body for certification of the aspects of manufacture relating to sterility ormetrology. Once the manufacturer is satisfied that his products meet all the relevant EssentialRequirements, he must register with the Competent Authority. He may then CE mark his products andplace them on the market.Class IIaAs for Class I, the manufacturer declares conformity with the provisions of the Directive and Regulationsand ensures that his products comply with relevant Essential Requirements. However, for Class IIaproducts, this declaration must be backed up in all cases with conformity assessment by a Notified Body.This assessment may, at the manufacturer’s choice, consist of:• Examination and testing of each product or homogenous batch of products (Annex IV of theDirective); or• Audit of the production quality assurance system (Annex V of the Directive) (harmonised standardEN 46002); or• Audit of final inspection and testing (Annex VI of the Directive) harmonised standard (EN 46003);or• Audit of the full quality assurance system (Annex II) (harmonised standard EN 46001).Once the manufacturer has received certification from the Notified Body he may CE mark his productsand place them on the market.Class IIbThere are two routes: a Notified Body must carry out either an Annex II audit of the full quality assurancesystem (EN 46001), or a type-examination (Annex III) plus one of the three options given in items i-iii
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