GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

EuropeAid /114385/D/SV/CYAssessment and administration capacity buildingfor the harmonisation with the New Approach directivesGUIDEto the implementation of theDIRECTIVES90/385/EEConAIMDActive implantable medical devicesand93/42/EEConMDDMedical Devices

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYThis Guide was printed with funds of the EuropeAid /114385/D/SV/CY project:“Assessment and administration capacity building for the harmonisation with the New Approach directives”The views expressed in this publication do not necessarily reflect the views of the European Commissionor the Cyprus Ministry of Commerce, Industry and Tourism.© Republic of Cyprus, Nicosia, May 2004

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYINTRODUCTIONThe information in this guide is intended as general guidance and should not be regarded as anauthoritative statement of the law. Manufacturers and others should not rely on this information but shouldconsult the legislation referred to, making their own decisions on matters affecting them in conjunctionwith their lawyers and other professional advisers.WHAT IS A MEDICAL DEVICE?A series of three Directives regulating the safety and marketing of medical devices throughout theEuropean Union started to come into effect from 1 January 1993.For the purposes of the Directives, a medical device is defined as:"any instrument, apparatus, appliance material or other article, whether uses alone or incombination, including the software necessary for its proper application intended by themanufacturer to be used on human beings for the purpose of:• diagnosis, prevention, monitoring, treatment or alleviation of disease,• diagnosis, monitoring, treatment, or alleviation of or compensation for an injury orhandicap,• investigation, replacement or modification of the anatomy or of a physiological process,• control of conceptionand which does not achieve its principal intended action in or on the human body bypharmacological, immunological or metabolic means, but which may be assisted in its function bysuch means".WHY DO WE NEED THE DIRECTIVES?Before the introduction of the medical devices Directives, each Member State in the EuropeanUnion would control the safety and marketing of medical devices on its territory in different ways.The Directives benefit manufacturers by harmonising controls within a single system and avoidthe need for manufacturers having to comply with 15 (or 25) different sets of rules. Purchasersand users can also be reassured that devices manufactured anywhere in the Union should meetcommon standards of performance and safety.The Directives benefit patients and users, by setting out essential requirements that productsmust meet. These make it clear that devices must not compromise the health or safety of thepatient, user or any other person, and that any risks associated with the device are compatiblewith patient health and protection. Any side effects must be acceptable when weighed against theintended performance of a device. Devices meeting these requirements generally carry the "CE"marking to show that they comply.THE DIRECTIVESTHE ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVEThis first Directive covers all powered implants or partial implants that are left in the human body. Heartpacemakers are the most common example of powered implants.

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 :

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CY• sterilisation of medical devices supplied non-sterile• assembling of systems• configuration of electronic equipment• preparation of a dental filling• fitting of contact lenses• adaptation of prosthesis to the needs of the patient.The aforementioned activities are normally not manufacturers activities if they are carried out by thefinal user as part of the use or preparation for use. In this context a distinction needs to be madebetween a typical professional activity performed by a healthcare professional and processing andassembling activities done by a specialist for such processing. In the latter case relevant activitiesmay become proper manufacturing or assembling activities relevant within the meaning of articles 11and 12.A particular consideration in this context needs to be given for the manufacture of custom-madedevices. Custom-made devices (such as dental appliances, prosthesis, hearing-aid inserts) are inmost cases one-off devices and the Directive subjects their manufacture to the procedure of article11(6) in conjunction with Annex VIII. In these cases intermediate products specifically intended forthis kind of custom-made devices may be considered also as medical devices.This applies essentially to dental alloys, dental ceramics, modular components for prosthesis, if theintended purpose of such products is specifically related to medical devices.d) medical - toiletry purposeThe definition of "medical device" should be understood to include products intended to be usedprincipally for a medical use. Therefore products intended to have a toiletry or cosmetic purpose arenot medical devices even though they may be used for prevention of a disease. Examples forproducts for which a medical purpose can normally not be established:• tooth brushes, dental sticks, dental floss;• baby diapers, hygiene tampons;• contact lenses without corrective function intended to provide another colour to the eyes,bleaching products for teeth• instruments for tattooing.Examples for products, where depending on the circumstances, a medical purpose can beestablished:incontinence products.e) aids for handicapped personsIn the case of equipment intended for alleviation of or compensation for a handicap, there must be adirect link between the corrective function and the person concerned. Therefore the followingequipment is not medical devices:f) software• acoustic signals at traffic lights,• special water taps, toilet equipment for handicappedThe following distinction can be made: software influencing the proper functioning of a device andsoftware used in combination with non-medical equipment.

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYSoftware related to the functioning of a medical device may be part of a device or a device in its ownright if it is placed on the market separately from the related device.In the case of software intended for use with multipurpose informatics equipment a distinction has tobe made between software providing for a proper diagnostic or therapeutic tool and software forhandling general patient-related data. Only in the first case may a medical purpose be determined.Examples for medical devices:• calculation of anatomical sites of the body,• image enhancing software intended for diagnostic purpose.• software for programming a medical deviceThere is no medical purpose in the case of software used for administration of general patient datag) multipurpose productsProducts with a multiple purpose which may be used occasionally in a medical environment arenormally not medical devices, unless a specific medical intended purpose is assigned to them.Examples:• multipurpose PC, printer, scanner, ...• magneto scope, screen.DEFINITION OF "ACCESSORY"The question whether a product is a "device" or an "accessory" has no practical consequence. Followingarticle 1(1) of Directive 93/42/EEC, "accessories shall be treated as medical devices in their own right".Therefore the main question is whether a product with a rather remote link to a medical use can still beconsidered as "accessory" (article 1(2)b) and as a matter of consequence is covered by the directive.The definition of "accessory" requires that the accessory is specifically intended by the manufacturer ofthe accessory to be used together with a device. The intended use of the accessory must be such as toenable a device to be used in accordance with its intended use. Therefore a product can only become anaccessory to a medical device if the manufacturer of such a product establishes an intended use inconjunction with one or several medical devices.Examples for accessories depending on defined circumstances of device related use:• sterilizers for use in a medical environment,• pouches for packaging re-sterilised medical devices,• specific battery chargers for battery driven electro medical devices,• contact lens care products, disinfectants specifically intended for invasive medical devices• special water treatment device for use in conjunction with dialyzing machines,• gas cylinders/pressure release devices for use in conjunction with anaesthesia machines.DEFINITION OF "MANUFACTURER"USERS IN-HOUSE MANUFACTURINGThe Directive defines a manufacturer as the natural or legal person responsible for defined manufacturingactivities related to a device with a view to its being placed on the market under the manufacturers ownname.

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYThe reason for this link with the placing on the market is that the directives aim to subject to its protectionrequirements the transaction of a device from the sphere of a manufacturer towards the public. Thedirective does not provide any specific provisions for the case where a device is manufactured by the user(for example, a hospital) without being transferred to another person. The decision to which extent suchin-house manufacturing activities by hospitals are subjected to legal requirements, belongs therefore tothe national legislator. This relates however exclusively to such in-house manufacturing activities where adevice remains within the users, but not to cases where, for example, a hospital produces orthopedicdevices for use with patients.DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICESACTIVE IMPLANTABLE MEDICAL DEVICEA product falls within the field of application of the Directive if it complies with the definition given in thisDirective. That means, it must be a "medical device" as defined which is, at the same time, both "active"and "implantable".a) DeviceThe "device" definition within the meaning of Directive 90/385/EEC relates to a product intended bythe manufacturer for a medical purpose "whether used alone or in combination, together with anyaccessories or software for its proper functioning". The medical purpose may be achieved either by a"stand alone device" or as a result of several devices acting each in combination with the other aspart of a system. Where the medical purpose is achieved by a system, each element of the systemmay be regarded as a medical device.The device definition may consequently apply to the system as such or to interchangeable partsintended to form a system together with other devices, therefore for the purposes of the Directive onActive Implantable Medical Devices each part belonging to such system is covered by the Directiveregardless of whether such part on its own is "active", "active implantable" or not.Examples of AIMDs :• implantable pulse generator for pacing including the electrode• implantable pulse generator without electrode• electrode• implantable drug administration device with or without catheter• catheter for implantable drug administration deviceb) Active deviceFor the purpose of the Directive 90/385/EEC a medical device is active if it "relies for its functioningon a source of electrical energy or any source of power other than that directly generated by thehuman body or gravity. This includes, for instance, devices activated by means of pressure unlessthis effect is achieved by energy resulting from the body of the patient. The definition implies that thefunction of the device involves using the source of power to perform useful work. The meretransmission of heat, light, pressure or vibration does not mean that a device is active.Examples :• a hydrocephalus pressure relief allowing release of cerebro-spinal fluid when a spring isovercome is not "active". Even where the setting of the spring can be adjusted by electromagneticmeans, it remains non-active as the medical function of the device is to relievepressure, not to be adjusted,

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CY• a drug delivery device in which the drug is driven from a reservoir by means of a storedenergy source (spring, fluid, gas, etc...) is "active"• an intravascular catheter containing a fibre-optic bundle connected to an external light sourcemay be used to measure pressure or other characteristics of blood if some quality of the lightcan be changed by the blood characteristic and detected. Although the system as a wholedepends on a power source to achieve its medical function (the measurement of a bloodcharacteristic) the invasive element is not "active" as it does no more than transmit light• a cochlear implant activated by an external power transmitter is regarded as "active" as theimplanted component clearly depends on a power source for its function and its purpose is toconvert the power it receives into electrical signals which trigger appropriate sensorychannels in the brain, i.e. it performs useful work.c) Implantable deviceAn active medical device is defined as "implantable" if it is "totally or partly introduced, surgically ormedically, into the human body or by medical intervention into a natural orifice, and which is intendedto remain after the procedure".The Directive has been conceived for active devices for which a potential high risk may be inherentdue to the fact that they are totally or partly implanted into the body. Such devices may presenthazards in particular with regard to impossibility of maintenance, calibration or control and problemsrelating to the ageing of materials, as mentioned in several essential requirements of Annex 1 to theDirective. The attribute "implantable" has therefore to be interpreted bearing in mind those hazardstypical for implantable devices.For the aforementioned reasons, an external drug infusion pump, although for long-term orpermanent use, which is connected to a catheter "partially introduced" into the body is not consideredas an active implantable device.One of the essential characteristics of an implantable device is its relatively long-term use. Distinctionis to be made between an intended use of a device which is permanent or longterm in the order ofseveral months compared to a temporary use during a given medical intervention. An externalpacemaker, including its electrode, used for an interim process is thus not considered as "remainingafter the procedure". The same applies to the use of an intra-aortic balloon pump. For the purpose ofthe Directive 90/385/EEC, the term "procedure" is to be interpreted as a process of diagnosis,monitoring or treatment which may last for some days, generally in hospital, and not necessarilyexclusively relating to an operation carried out in the theatre in the course of which the device isplaced in the body.DEFINITION OF ACCESSORY"Accessories" to an active implantable medical device are by definition "active implantable medicaldevices" and therefore covered by the Directive 90/385/EEC. This does not presuppose that theattributes "active" and "implantable" must be necessarily met by a product called "accessory". It issufficient that a product in its intended purpose is ancillary to the purpose of an active implantablemedical device in such a way that it enables the device to be used in accordance with the intendeddevice purpose or that it enhances the purpose of a device as intended by the device manufacturer.Following this a programmer or an external transmitter intended for activating or controlling theimplantable part of the device is covered by the definition of "active implantable medical device".

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYEXEMPLATIVE LIST OF ACTIVE IMPLANTABLE MEDICAL DEVICES.The subsequent list contains examples of types of devices which are normally covered by Directive90/385/EEC :1. implantable cardiac pacemakers2. implantable defibrillators3. leads, electrodes, adaptors for 1. and 2.4. implantable nerve stimulators5. bladder stimulators6. sphincter stimulators7. diaphragm stimulators8. cochlear implants9. implantable active drug administration device10. catheters, sensors for 9.11. implantable active monitoring devices12. programmers, software, transmitters.INTERFACES WITH OTHER DIRECTIVESDIRECTIVE 65/65/EEC RELATING TO MEDICINAL PRODUCTSA product will normally only be subject to the requirements of either one of the medical devices directivesor the directive on medicinal products. In order to decide which of these Directives applies, the followingpoints should be considered:• the intended purpose of the product taking into account the way the product is presented;• the method by which the principal intended action is achieved.In the case of a medical device, the principal intended action is typically fulfilled by physical means(including mechanical action, physical barrier, replacement of, or support to, organs or body functions).The action of a medicinal product is typically achieved by pharmacological, immunological or metabolicmeans; a substance administered for diagnostic purposes is also usually considered to be a medicinalproduct.Medical devices may be assisted in their function by pharmacological, immunological or metabolic means.Where such means are primary with respect to the principal purpose of the product, it is regarded as amedicinal product.Devices that incorporate or are used to administer a drug are covered by the Medical Devices Directive,except for active implantable devices (e.g. implantable infusion pumps) used to administer a drug whichare covered by the Active Implantable Devices Directive.As indicated above, the intended principal function of the product and the method by which this action isachieved determines the legislation relevant to the products.There are three types of device which incorporate or are used to administer a product:

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

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CY• surgical gloves, examination gloves• face masks• corrective glasses (including those intended at the same time for sun protection)• surgeons gowns and hatsExamples for personal protective equipment• protective gloves (for example, for use in a medical laboratory)• clothing for protection against ionizing radiation• sun glasses• eye protection devices for professional use (for example, for welders, regardless of whether or notthey contain corrective glasses adapted to the need of the user)• gum shields for boxers.CLASSIFICATION OF MEDICAL DEVICES COVERED BY DIRECTIVE93/42/EECBACKGROUNDDirective 93/42/EEC relating to medical devices covers a vast range of products from first-aid bandagesand walking frames to CT scanners and non-active implants. While the use of many of these presents nodanger, others may carry significant risks to patients or users. However, to apply the strictest controls toall products would require some manufacturers to set up additional, costly, and unnecessary procedures.It is important, therefore, that the level of control is matched, as far as possible, to the degree of riskinherent in the device. Attempts were therefore made to set the controls relative to the perceived risk in aneffort to make them as relaxed as possible (thus easing the bureaucratic and financial burdens onbusiness) and as strict as necessary (thus ensuring that the health of the patient and user is adequatelyprotected).THE CLASSESDevices covered by the Directive are grouped into 4 classes as follows:• Class I - generally regarded as low risk• Class IIa - generally regarded as medium risk• Class IIb - generally regarded as medium risk• Class III - generally regarded as high risk.The difference between each Class rests in the choice of conformity assessment procedures available(see Section D).CLASSIFICATION RULESThe Rules are a set of broad statements relating to situations, functions, parts of the body treated,properties etc, rather than a list of products which would require constant updating. This has the merit ofbeing more flexible and better able to accommodate new developments in medical technology.There are 4 groups within the Rules as follows:

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CY• Rules 1-4 - non-invasive devices• Rules 5-8 - invasive devices• Rules 9-12 - additional Rules applicable to active devices• Rules 13-18 - miscellaneous Rules for products which merit a higher classification than they mightotherwise be assigned.a) non-invasive devicesRULE 1places any non-invasive product in Class I if other Rules do not apply.RULE 2places products which channel and store blood and other body liquids for administration into the bodyin Class IIa, except blood bags which will be Class IIb (see Rule 18). Products for storing andchanneling other substances will be in Class I unless they are connected to an active medical devicein a higher Class, in which case they are in Class IIa.RULE 3places products which alter the biological or chemical composition of blood or other liquids introducedinto the body in Class IIb unless the treatment consists of filtration, centrifugation or exchange of gasor heat, in which case they are in Class IIa.RULE 4covers non-invasive devices, which come into contact with injured skin. This Rule covers dressingsand can place them in Class I in the simplest cases (sticking plaster) or Class IIa. More complexproducts, such as those which are intended principally for use with wounds which have breached thedermis and can only heal by secondary intent, are in Class IIb.b) invasive devicesRULE 5covers only devices which are invasive with regard to body orifices i.e. it does not cover surgicallyinvasive devices. The devices covered can be in Class I, Class IIa or Class IIb depending on theduration of continuous use and the degree to which they are inserted in the body. If they are intendedfor connection to an active device they are regarded as Class IIa products.RULES 6, 7 AND 8all cover surgically invasive devices and are applicable depending on the duration of continuous use.They are more complex than earlier Rules because they contain exceptions relating to specificfunctions (such as being specially designed for use where there are defects in the central circulatorysystem or the heart) or specific properties (such as emitting ionising radiation or being absorbable).Basically, products will be in Class IIa if they are for transient or short-term use and in Class IIb forlong-term use. But they will move up into a higher class if they additionally have special propertiessuch as those mentioned above. One exception is that simple reusable surgical instruments are inClass I.c) additional rules applicable to active devicesRULE 9covers active therapeutic devices, which administer or exchange energy. They will generally be inClass IIa, but in particular cases may be in Class IIb if they carry out their function in a potentiallyhazardous way.

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.

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

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;

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CY(f)(g)(h)(I)(j)Information regarding the risks of reciprocal interference posed by the presence of the deviceduring specific investigations or treatment;The necessary instructions in the event of damage to the sterile packaging and, whereappropriate, details of appropriate methods of resterilization;if the device is reusable, information on the appropriate processes to allow reuse, includingcleaning, disinfection, packaging and, where appropriate, the method of sterilization of the deviceto be resterilized, and any restriction on the number of reuses.details of any further treatment or handling needed before the device can be used (for example,sterilization, final assembly, etc.);In the case of devices emitting radiation for medical purposes, details of the nature, type, intensityand distribution of this radiation.The instructions for use must also include details allowing the medical staff to brief the patient on anycontra-indications and any precautions to be taken. These details should cover in particular:(k)(l)(m)(n)(o)(p)Precautions to be taken in the event of changes in the performance of the device;precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions,to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations inpressure, acceleration, thermal ignition sources, etc.;Adequate information regarding the medicinal product or products which the device in question isdesigned to administer, including any limitations in the choice of substances to be delivered;Precautions to be taken against any special, unusual risks related to the disposal of the device;Medicinal substances incorporated into the device as an integral part;Degree of accuracy claimed for devices with a measuring function.SOME OTHER REGULATORY ISSUESVIGILANCE – REPORTING OF ADVERSE INCIDENTSIncidents can occur with medical devices where they do not perform as intended, leading in the worstcase to injury, additional medical procedure or death. The Directives therefore impose timely co-ordinatedaction and provision of information between manufacturer and national authority concerned and betweennational authorities in relation to incidents that present a serious risk and that are related to the device.Member States have to take the necessary steps to ensure that any information brought to theirknowledge in accordance with the provisions of the Directive regarding specific incidents involving medicaldevices (regardless of their class) is recorded and evaluated centrally:These provisions relate primarily to information provided by the manufacturer to national authoritiesconcerning medical devices. The scheme does not relate to errors in use, unless such errors can beexplained by shortcomings in the design of the product or of its accompanying labeling or instructions foruse.As part of national policy, a Member State can also require medical practitioners or the medical institutionsto inform the competent authorities of any such incidents. In that case, it shall ensure that themanufacturer of the device concerned, or his authorised representative established in the Community, isalso informed of the incident.

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYCLINICAL INVESTIGATIONThe Directives require conformity assessment of characteristics and performances to be carried under thenormal conditions of use of the device and evaluation of the undesirable side effects to be based “as ageneral rule”-on clinical data. The adequacy of the clinical data must be based on either a compilation ofthe relevant scientific literature currently available and a critical evaluation of this compilation, or theresults of clinical investigation. The clinical data must be available for all medical devices, irrespective ofclassification. Clinical investigation programmes must be notified to the Competent Authority of theMember State in which the investigation is to be conducted.MARKET SURVEILLANCEMarket surveillance is an essential tool for the enforcement of the Medical Devices Directives, in particularwith regard to Class I medical devices, placed on the market without the intervention of a Notified Body inthe conformity assessment procedure. Its purpose is to verify that the provisions of the Directive arecomplied with across the Community, to ensure a common level of safety and to eliminate unfaircompetition.HARMONISED STANDARDSIn order to show compliance the manufacturer can choose between different routes – known asConformity Assessment Procedures - set out in Annexes to the Directives and, where appropriate, selecta notified body to carry out these procedures.Manufacturers of many kinds of devices, will need to show, by consulting a notified body, how theirproducts meet the Essential Requirements BEFORE placing them on the market.Other manufacturers may be required by the Competent Authority to show how their products meet theEssential Requirements AFTER they have been placed on the market.Manufacturers of custom-made devices or devices intended for clinical investigation may also be requiredby the Competent Authority to demonstrate how their products comply with the Essential Requirements. Innearly all cases, the application of standards will help with this process.USING STANDARDSSince the Directives cover a wide range of products, involving many levels and types of technology, theEssential Requirements can only provide a broad approach in setting thetargets that manufacturers must meet. The European Commission, therefore, has mandated theEuropean standards organisations to prepare European standards to address the EssentialRequirements. These standards will assist manufacturers by setting out• objective definitions of what the necessary requirements are for particular products, and• practical means for manufacturers to show that their products comply with the EssentialRequirements.They thus help to eliminate potential difficulties which otherwise may be experienced by industry whenasked to provide justification for claims of compliance with the Essential Requirements.It is important, therefore, that manufacturers are aware of the standards that have been, and are being,adopted for these purposes.Manufacturers may need to refer to more than one standard in order to address the relevant EssentialRequirements pertinent to a given medical device.

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYThe most suitable standard(s) should be selected in cooperation between the manufacturer and thenotified body, if any, in such a way as to minimise the risk that products might not comply with theEssential Requirements.The European standards organisations i.e. the European Committee for Standardisation (CEN) and theEuropean Committee for Electrotechnical Standardisation (CENELEC) develop European standards tocover various products or product groups.Once a European standard has been agreed, it becomes binding on all national standards bodies inEurope, and any conflicting national standard has to be withdrawn.European standards, mandated by the European Commission, that are accepted as addressing identifiedEssential Requirements in a Directive are listed in the Official Journal of the European Communities, andare generally referred to as harmonised standards. Products manufactured in line with such standards willbe presumed to comply with the relevant Essential Requirements unless there is specific evidence to thecontrary.Many standards are developed at a wider international level, through the International Organisation forStandardisation (ISO) and the International Electrotechnical Commission (IEC). Very often the finallypublished ISO or IEC standard is also adopted as a European standard.Other harmonised standards will define the characteristics of manufacturers' quality management systemswhich are relied on to ensure that medical devices are designed and manufactured correctly. Again thereis a presumption of compliance if a quality management system complies with the relevant harmonisedstandard i.e. the notified body must presume that it complies with the requirements of the Directive.Manufacturers may choose whether or not to apply relevant harmonised standards. In practice, however,compliance with these standards will be the easiest way of showing that their products meet the EssentialRequirements.Since the application of harmonised standards will be voluntary, manufacturers may choose alternativemethods of demonstrating compliance with the Essential Requirements.For example, manufacturers may use international, national or in-house standards. These alternativeroutes may also be used where harmonised standards do not exist for a particular product or EssentialRequirement(s).Further information on standards and guidance information can be obtained from the Standards Body ofCyprus:CYSCyprus Organisation for the Promotion of QualityAt the Ministry of Commerce, Industry and Tourism13-15, Andreas Araouzou Street1421 NicosiaInternet : http://www.cys.mcit.gov.cyCENEuropean Committee for StandardizationRue de Stassart, 36, B - 1050 BRUSSELSTel: +32.2.550 08 11Fax: +32.2.550 08 19Internet : http://www.cenorm.be

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYFURTHER INFORMATIONInformation on medical devices Directives, harmonised standards, and competent authorities notifiedbodies, etc. may be obtained from the web site of the European Commission at;http://europa.eu.int/comm/enterprise/medical_devices/index.htmConsolidated texts of the Directives may be downloaded from:http://www.europa.eu.int/eur-lex/en/consleg/index1.htmlFurther information and links to all relevant European websites are available atwww.cys.mcit.gov.cyunder the button named:NEW APPROACHCYPRUS COMPETENT AUTHORITYIn Cyprus the Ministry of Health is responsible for enforcement of the medical devices regulations. Furtherdetails on enforcement and penalties are available at Cyprus Contact point at theMinistry of HeathContact:Mary Avraamidoumavraamidou@mphs.moh.gov.cyStelios Christofidesmpd.mh@cytanet.com.cy

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYCYPRUS LEGISLATIONGeneral requirements and stipulation are layed down in the Cyprus Framework Law N. 30(I)2002(published 5.4.2002) and its amendment Framework Law (Amend.) N. 29(I)2003 (published 28.3.2003).The Framework Law represents the legal basis for the Cyprus Regulations addressing respectiveDirectives.The Cyprus Regulation addressing the MDD directive is Regulation P.I. 598/2003 (published 18.7.2003)and the AIMD directive is Regulation P.I. 599/2003 (published 18.7.2003).Furthermore, the IVDD (In vitro diagnostic medical devices) directive is implemented as RegulationP.I. 597/2003 (published 18.7.2003).

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYANNEX:CONFORMITY ASSESSMENT FLOW CHARTSChart 1: Directive 93/42/EEC relating to medical devices (1)

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYChart 2: Directive 93/42/EEC relating to medical devices (2)

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYChart 3:Directive 90/385/EEC relating to active implantable medical devices