General-Safety-and-Performance-Requirements

General Safetyand PerformanceRequirementsItem The requirement ofMedical DeviceRegulation2017/745Applic StandardEvidence ofConformityableGENERAL REQUIREMENTS

11.Devices shallachieve the performance intended by theirmanufacturer and shall beA ENISO15223-1:2016LabelInstruction ofUsedesignedand manufactured in such a way that,during normal conditions of use,they aresuitable ENISO14971:2012Risk ManagementReportfortheir intended purpose.They shall be safe and effectiveand shall not compromise the ISO10993-1:2018clinicalcondition or the safety of patients,or the safety andhealth of users or,where applicable,ENISO10993-5:2009BiocompatibilityotherAssessment Reportpersons,provided that any riskswhich may be associated with their use constituteENISO10993-10:2013acceptablerisks whenweighed againstthe benefits to the patient and are compatible with ahigh EN14126:2003Performance Testinglevel ofReportprotection ofhealth and safety,taking into account the generally acknowledgedstate ofthe art.EN ISO11135:2014Sterilization ValidationReportEvaluationof ClinicalMEEDEV

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7.1Rev.4Report

22.Therequirement in thisAnnex to reduce risks as far as possiblemeans thereduction A ENISO14971:2012Risk ManagementReportof risksas far as possiblewithout adverselyaffecting the benefit-risk ratio.ISO13485:2016ISO13485qualitymanagement systemdocumentsDesign and DevelopmentControlProcedure

13.

2.For devicesmanufactured utilizingtissues orcells of animal origin,or theirderivatives,NA/Not utilizetissues orcells ofwhich are non-viable or rendered non-viable the following shall apply:a wherefeasible takinganimal origin.into account the animalspecies,tissues and cells of animal origin,or theirderivatives,shalloriginate fromanimals thathave beensubjected toveterinary controlsthat areadapted to theintended use of the tissues.Information on the geographicalorigin of the animalsshall beretainedby manufacturers;b sourcing,processing,preservation,testing andhandling of tissues,cells and substances ofanimal origin,or theirderivatives,shall be carried out so as to provide safety for patients,usersand,where applicable,other persons.In particularsafety withregard toviruses and othertransmissible agentsshall be addressed by implementation of validated methods of eliminationorviral inactivation in the course of the manufacturing process,except when the use of suchmethodswould leadtounacceptabledegradation compromising the clinicalbenefit of thedevice;c in the case of devicesmanufactured utilizingtissues orcells of animal origin,or theirderivatives,as referred to in Regulation EU No722/2012the particularrequirements laid downin thatRegulation shallapplyNA/Not utilizenon-viable biological

13.

3.For devicesmanufactured utilizingnon-viable biologicalsubstances otherthan thosesubstances.referred to in Sections

13.1and

13.2,the processing,preservation,testing andhandling of thosesubstances shall be carriedout soas to provide safetyfor patients,users and,whereapplicable,other persons,including in the wastedisposal chain.In particular,safety withregardtoviruses andother transmissibleagents shall be addressedbyappropriate methods of sourcingand byimplementationofvalidated methodsofelimination or inactivation in the courseof themanufacturingprocess.14Construction of devices and interaction with their environment

14.

1.If the device is intended for use in combination with other devices or equipmentthe wholeNA/Not incombination with othercombination,including theconnection system shall besafeandshallnotimpair the specified devices.performance of the devices.Any restrictionson useapplying to such combinationsshall be indicated on the label and/or inthe instructions for use.Connections which the userhas to handle,such asfluid,gas transfer,electrical ormechanical coupling,shall be designed andconstructed in such a way as tominimize allpossible risks,such asmisconnection.NA EN ISO14971:2012Risk managementreport.EN14126:2003Performance testingreport.

14.

2.Devices shall be designed and manufactured in such a way as toremove or reduceas far as possible:a the risk ofinjury,in connectionwith theirphysical features,including thevolume/pressureratio,dimensional andwhere appropriateergonomic features;b risksconnected withreasonably foreseeableexternal influences or environmentalconditions,such asmagnetic fields,external electricaland electromagnetic effects,electrostaticdischarge,radiation associatedwith diagnosticor therapeutic procedures,pressure,humidity,temperature,variations inpressure and acceleration orradio signalinterferences;c the risks associatedwith the use of the devicewhen itcomes intocontact withmaterials,liquids,and substances,including gases,to which it isexposed during normalconditions of use;d the risks associatedwith thepossible negativeinteraction betweensoftware and the ITenvironmentwithin whichit operatesand interacts;ethe risks of accidental ingressof substancesinto the device;fthe risks of reciprocalinterference with other devicesnormally usedin theinvestigations orfor the treatmentgiven;andg risksarising wheremaintenance orcalibration arenot possibleas withimplants,fromageing ofmaterials usedor lossof accuracyof anymeasuring or control mechanism.NA ENISO14971:2012Risk managementreport.EN14126:2003Performance testingreport

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3.Devices shall be designed and manufactured in such a way as tominimize the risks offireor explosionduringnormaluse and in single fault condition.Particular attentionshall bepaid todevicesthe intended use ofwhich includesexposure toorusein associationwith flammableorexplosive substances or substanceswhich couldcause combustion.

14.

4.Devices shall be designed and manufactured in such a way that adjustment,calibration NA/Not needadjustment,calibrationand maintenancecan bedone safely and effectively.and maintenance.

14.

5.Devices that are intended to beoperated together withother devices orproducts shall be NA/Not operatetogether withotherdesigned and manufactured in such a way that the interoperabilityand compatibilityare reliabledevice.andsafe.

14.6Any measurement,monitoring or display scaleshall be designed and manufacturedinline NA/Not ameasurement,monitoringwith ergonomicprinciples,taking accountof the intended purpose,users and the environmentalordisplayscale.conditions in which the devices are intended to be used.

14.

7.Devices shall be designed and manufacturedin such a way as to facilitate their safe NA EN1041:2008Labeldisposal and thesafe disposal ofrelated wastesubstances by the user,patient or other person.Instruction ofUse.lb thatend,manufacturers shallidentify andtest proceduresand measuresas aresult ofwhichtheir devices can besafely disposedafter use.Such proceduresshall bedescribed in the instructions for use.15Devices with a diagnosticor measuring function

15.

1.Diagnostic devices and devices with a measuring function,shall be designed and NA/Not diagnosticdevice.manufacturedin such a way as toprovidesufficient accuracy,precision andstability for theirintended purpose,based on appropriate scientificand technicalmethods.The limitsof accuracyshall beindicated by the manufacturer.

15.

2.The measurementsmade by devices with ameasuringfunction shall be expressedin NA/Not ameasure device.legal unitsconforming to the provisionsof CouncilDirective80/181/EEC16Protection againstradiation

16.

1.General NA/No radiationaDevices shall be designed,manufactured and packaged in such a way that exposure ofpatients,users andother personsto radiationis reducedas far as possible,and in a mannerthatis compatiblewith the intended purpose,whilst notrestricting theapplication of appropriatespecified levels for therapeuticand diagnosticpurposes.b Theoperating instructions for devicesemitting hazardousor potentiallyhazardousradiation shall contain detailed information as to the nature of the emittedradiation,the means ofprotecting the patient and the user,and onways ofavoiding misuse and ofreducing the risksinherent to installation as far as possible and appropriate.Information regarding the acceptanceand performance testing,the acceptancecriteria,and the maintenance procedureshall alsobespecified.NA/Not intendedradiation.

16.

2.Intended radiationWhere devices aredesigned to emit hazardous,or potentiallyhazardous,levels ofionizingand/or nonionizing radiation necessaryfor a specific medical purpose thebenefit ofwhich isconsidered to outweighthe risksinherent to the emission,it shall be possiblefor the user tocontrolthe emissions.Such devices shall be designedand manufactured to ensurereproducibility ofrelevant variableparameters within an acceptabletolerance,a Wheredevicesare intended to emithazardous,or potentiallyhazardous,ionizingand/or non-ionizing radiation,they shall be fitted,where possible,with visualdisplays and/oraudible warningsof suchemissions.NA/No radiation.

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3.Devices shall be designedand manufacturedin such a way thatexposureof patients,users andother personsto theemission ofunintended,stray orscattered radiationis reducedasfar as possible.Where possibleand appropriate,methods shall be selectedwhich reducetheexposure toradiation ofpatients,users andother personswho may be affected.NA/No ionizingradiation.

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4.Ionising radiationaDevices intended toemitionizingradiation shall be designedand manufactured taking intoaccount therequirements of the Directive2013/59/Euratom layingdown basicsafety standardsforprotection againstthe dangersarising fromexposure toionising radiation.b Devices intended toemit ionising radiationshall be designedand manufacturedin suchaway as to ensure that,where possible,taking into account the intended use,the quantity,geometry andquality of the radiationemitted can be variedand controlled,and,if possible,monitored duringtreatment.c Devicesemitting ionisingradiation intended for diagnosticradiology shall be designedandmanufactured in sucha way as to achievean imageand/or outputquality that are appropriatetothe intendedmedicalpurposewhilst minimisingradiation exposureof the patient anduser.d Devices that emitionisingradiation andare intended for therapeutic radiologyshall bedesignedand manufacturedin sucha wayas to enable reliablemonitoring andcontrol ofthedelivered dose,the beamtype,energy and,where appropriate,the qualityof radiation.17Electronic programmable systems——devices that incorporate electronicprogrammable systemsand softwarethat ared evicesin themselves

17.

1.Devices thatincorporate electronicprogrammable systems,including software,or NA/No electronicprogrammablesoftware that are devices in themselves,shall be designed to ensure repeatability,reliability andsystem.performance inline with their intended use.In the event ofa singlefault condition,appropriatemeans shall be adoptedto eliminateor reduce as far as possibleconsequent risksor impairmentofperformance.NA/No software

17.

2.For devices thatincorporatesoftware orfor softwarethat are devicesin themselves,thesoftware shall be developedand manufacturedin accordance with the state of thearttaking intoaccount the principlesof developmentlife cycle,risk management,including informationsecurity,verification andvalidation.NA/No software

17.

3.Software referred to inthis Sectionthat is intendedto be usedincombinationwith mobilecomputingplatforms shall be designedand manufacturedtaking into account thespecificfeatures of themobile platforme.g.sizeand contrastratioof thescreenand theexternalfactorsrelated to theirusevarying environmentas regardsleveloflight ornoise.

17.

4.Manufacturers shallset outminimum requirementsconcerning hardware,IT networksNA/No softwarecharacteristics and ITsecurity measures,including protectionagainst unauthorisedaccess,necessary torun thesoftware as intended.18Active devices and devicesconnected to themNA/Not activedevices.

18.

1.For non-implantable activedevices,in the event ofa singlefault condition,appropriatemeans shall be adoptedto eliminateor reduce as far as possibleconsequent risks.NA/Not activedevices.

18.

2.Devices where the safety of the patient depends onaninternal power supply shall beequipped witha means of determiningthestate of the power supplyand anappropriate warningor indication forwhen thecapacity of the powersupply becomescritical.If necessary,suchwarning orindication shall be givenprior to thepowersupply becomingcritical.NA/Not activedevices.

18.

3.Devices wherethe safetyof thepatientdependsonan externalpowersupplyshall includeanalarm systemto signalany powerfailure.NA/Not activedevices.

18.

4.Devices intendedto monitor one ormore clinicalparameters ofa patientshallbeequippedwith appropriatealarm systemsto alertthe user of situationswhich couldlead todeathor severedeterioration of the patientsstateofhealth.

18.

5.Devices shallbe designedand manufacturedin sucha wayas toreduce as far as NA/Not activedevices.possible the risks ofcreating electromagnetic interference which could impairthe operationofthedevice inquestion or other devicesor equipmentin the intended environment.NA/Not activedevices.

18.

6.Devices shallbe designedand manufacturedin sucha wayas toprovide alevel ofintrinsicimmunity toelectromagnetic interferencesuch that is adequatetoenablethem tooperateas intended.NA/Not activedevices.

18.

7.Devices shallbe designedand manufacturedin sucha wayas toavoid,as faras possible,the risk ofaccidentalelectric shocksto the patient,user or any otherperson,both duringnormaluse of the device andinthe eventofa singlefaultcondition inthe device,provided the device isinstalled and maintained as indicated by the manufacturer.

18.

8.Devices shallbe designedand manufacturedin sucha wayas toprotect,as farasNA/Not activedevices.possible,against unauthorisedaccess that could hamperthe devicefrom functioningas intended.19Particular requirements for active implantable devices

19.

1.Active implantable devices shallbe designedand manufacturedin sucha wayas toNA/Not activeimplantable devices.remove orminimize as faras possible:a risksconnected with theuse of energysources withparticular reference,where electricityisused,to insulation,leakage currentsand overheating of the devices,b risksconnected withmedicaltreatment,in particularthose resulting from theuse ofdefibrillators orhighfrequencysurgical equipment,andc riskswhich mayarise wheremaintenance andcalibration areimpossible,including:—excessive increaseof leakagecurrents,—ageing of the materials used,—excess heatgenerated by the device,decreased accuracyof anymeasuring orcontrol mechanism.

19.

2.Active implantable devices shallbe designedand manufacturedin sucha wayas toNA/Not activeimplantable devices.ensureif applicable,the compatibilityof the deviceswith the substancesthey areintended toadminister,and—the reliabilityof thesource of energy.NA/Not activeimplantabledevices.

19.

3.Active implantabledevices and,if appropriate,their component parts shallbe identifiabletoallow any necessary measureto be taken followingthe discoveryofapotential riskinconnection with the devicesor theircomponentparts.NA/Not activeimplantabledevices.

19.

4.Active implantabledevices shall bear acode bywhich theyand theirmanufacturer can beunequivocally identifiedparticularly withregard to the typeofdevice and itsyear ofmanufacture;it shallbe possibleto readthis code,if necessary,without theneed for a surgicaloperation.20Protection againstmechanical and thermal risks

20.

1.Devices shallbe designedand manufacturedin sucha wayas toprotect patientsand NA/Not activedevices.users againstmechanical risksconnected with,for example,resistance tomovement,instabilityand movingparts.

20.

2.Devices shallbe designedand manufacturedin sucha wayas toreduce to the lowestNA/Not activedevices.possible levelthe risksarising fromvibration generatedby the devices,taking accountoftechnical progressand of the meansavailable forlimiting vibrations,particularly atsource,unless thevibrations arepart of thespecifiedperformance.

20.

3.Devices shallbe designedand manufacturedin sucha wayas toreduce to the lowestNA/Not activedevices.possible levelthe risksarising from the noise emitted,taking accountof technicalprogress andof the meansavailable toreduce noise,particularly atsource,unless thenoiseemittedis part ofthe specifiedperformance.

20.

4.Terminals and connectors to the electricity,gas orhydraulic and pneumatic energyNA/No terminalsandconnectorstosupplies which the useror otherperson has tohandle,shallbe designed andconstructed in suchthe electricity,gas orhydraulica wayas tominimise allpossible risks.andpneumaticenergy supplies.

20.

5.Errors likelyto be made whenfitting or refitting certainparts whichcould be a sourceof NA/No fittingorrefittingparts.risk shallbe madeimpossible by the design and constructionof suchparts or,failing this,byinformation givenon theparts themselvesand/or theirhousings.The sameinformation shallbe givenon movingparts and/or theirhousings wherethe directionofmovement needsto beknown in order toavoid arisk.

20.

6.Accessible parts of devicesexcluding theparts orareas intendedto supplyheat orreach NA/No accessibleparts.given temperaturesand theirsurroundings shallnot attainpotentially dangeroustemperaturesunder normalconditions of use.21Protection againstthe risks posed to the patient or userbydevicessupplying energy or substances

21.

1.Devices forsupplying the patient withenergy or substances shallbe designedandNA/Do notsupply the patient withenergyor substances.constructedin sucha waythat the amountto bedelivered can be setandmaintainedaccuratelyenough toensure thesafetyof thepatientand of the user.NA/Do notsupply thepatient withenergyor substances.

21.

2.Devices shallbe fittedwith the meansofpreventing and/or indicatingany inadequaciesinthe amountofenergydelivered or substances deliveredwhichcouldpose adanger.Devicesshall incorporatesuitable meansto prevent,as faras possible,the accidentalrelease ofdangerouslevels ofenergyor substances froman energyand/orsubstancesource.NA/No controlsor indicators.

21.

3.The functionof thecontrolsandindicators shallbeclearly specifiedon thedevices.Wherea devicebears instructionsrequired forits operationor indicatesoperating oradjustmentparameters bymeansofa visualsystem,such information shallbeunderstandable to the userand,as appropriate,thepatient.22Protection againsttherisksposed bymedical devices intended by the manufacturerfor use by lay persons

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1.Devices for use by lay personsshallbe designedand manufacturedin suchawaythatA ENISO15223-1:2016Labelthey performappropriately for their intended purpose takingintoaccountthe skillsand theEN1041:2008Instruction ofUsemeans available to lay persons andthe influenceresultingfromvariation thatcanbereasonablyanticipated inthe lay persons techniqueand environment.The informationand instructionsprovidedby the manufacturer shallbe easyfor thelaypersonto understandand apply.

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2.Devices for use bylaypersonsshallbe designedand manufacturedinsuchawayasto:A ENISO15223-1:2016Label-ensure that the device canbeused safelyand accuratelyby theintended userat allstages ofInstruction ofUsethe procedure,if necessaryafter appropriatetraining and/or information,-reduce,as faras ENISO14971:2012Risk managementreportpossible andappropriate,theriskfrom unintended cuts and pricks such as needle stick injuries,and-reduce as faras possible therisk oferror by theintended user inthe handling of the deviceand,if applicable,intheinterpretation of the results.

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3.Devices for usebylaypersonsshall,where appropriate,include aprocedure bywhich theA ENISO15223-1:2016Labellay person:EN1041:2008Instruction ofUse—can verifythat,atthe time of use,the devicew川perform asintendedby the manufacturer,and——if applicable,is warnedif the device hasfailed toprovide avalid result.REQUIREMENTS REGARDINGTHE INFORMATIONSUPPLIED WITHTHE DEVICELabeland instructions for use23A LabelIFUENISO15223-1:

201623.

1.General requirementsregarding the information supplied by the manufacturer EachEN1041:2008device shallbe accompaniedby the information neededto identifythe deviceand itsmanufacturer,and byany safety and performanceinformation relevanttothe user,or any otherperson,as appropriate.Such informationmay appear on the device itself,on the packaging orinthe instructions for use,andshall,if the manufacturer hasa website,be made available andkeptup todate on the website,takingintoaccountthe following:a Themedium,format,content,legibility,and locationof the labelandinstructions for use shallbe appropriateto theparticulardevice,its intendedpurpose andthe technicalknowledge,experience,education ortrainingof theintended users.In particular,instructions for use shallbe writtenin termsreadilyunderstood by theintendeduser and,where appropriate,supplemented withdrawings anddiagrams.b The information requiredon thelabel shallbe providedon the device itself.If thisis notpracticableor appropriate,some orall of theinformationmay appearon the packaging foreachunit,and/or onthe packagingof multiple devices.c Labelsshallbe provided in a human-readable formatand may be supplementedbymachine-readable information,such asradio-frequency identificationRFID or bar codes.d Instructionsfor use shallbe provided togetherwith devices.By wayof exception,instructionsforuse shallnot berequired forclass Iand classIla devicesif such devicescanbeused safelywithout anysuch instructionsand unlessotherwise providedfor elsewherein thisSection.e Wheremultipledevices are suppliedtoasingle user and/or location,asinglecopy of theinstructions foruse may beprovidedif soagreedby thepurchaserwho inany casemayrequestfurther copiesto beprovided freeof charge.f Instructionsforusemaybeprovided tothe userin non-paper formate.g.electronic totheextent,and onlyunder theconditions,set outinRegulation EUNo207/2012orinany subsequentimplementing rulesadopted pursuant to this Regulation.gResidual riskswhich are required to be communicatedtothe user and/or otherperson shallbe included as limitations,contra-indications,precautions orwarningsintheinformation suppliedbythe manufacturer.h Whereappropriate,theinformationsuppliedbythe manufacturershall takethe formof internationallyrecognised symbols.Any symbolor identificationcolourused shallconform tothe harmonisedstandards orCS.In areasfor whichno harmonisedstandards orCS exist,the symbolsand coloursshallbedescribed inthedocumentation suppliedwith the device.

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2.Information onthelabelENISO15223-Instruction ofUseThe labelshallbearall of the followingparticulars:1:2016a the name ortrade nameof the device;EN1041:2008Labelb thedetails strictlynecessaryforauser toidentifythe device,thecontents of thepackagingand,where it is notobvious for theuser,the intendedpurposeof thedevice;c thename,registered tradename orregistered trademark of themanufacturer andtheaddress of its registered place ofbusiness;dif themanufacturer hasits registeredplace ofbusiness outsidethe Union,thenameof the authorised representativeand addressof theregisteredplaceofbusiness of theauthorisedrepresentative;e where applicable,an indication that the device containsor incorporates:—a medicinalsubstance,including ahuman bloodor plasmaderivative,or—tissues orcells,or theirderivatives,of human origin,or——tissues orcells ofanimal origin,ortheirderivatives,as referred to inRegulationEUNo722/2012;f where applicable,information labelledin accordance with Section

10.

4.

5.;gthelot numberorthe serial numberof the device precededbythe words LOTNUMBER orSERIAL NUMBERoranequivalent symbol,as appropriate;htheUDI carrierreferred to in Article274and PartC of Annex VII;i anunambiguous indication oftthetime limit for using or implanting the device safely,expressed atleast interms of year and month,where thisis relevant;G wherethere isno indicationof the date untilwhen itmaybeused safely,thedate of manufacture.This dateof manufacturemaybeincludedaspart of the lotnumberor serialnumber,provided thedate isclearly identifiable;k an indicationof any specialstorage and/or handlingcondition thatapplies;l if the device is supplied sterile,an indicationofitssterile stateandthesterilisation3A ENISO14971:2012Risk ManagementReportManufacturers shallestablish,implement,document andmaintain arisk managementsystem.Risk managementshallbeunderstood asa continuousiterative processEN14126:2003Performance testingreportthroughout theentire lifecycleofa device,requiring regularsystematic updating.Incarrying outrisk managementmanufacturers shall:a establishand documenta riskmanagementplan foreach device;ISO13485qualityb identifyand analysethe knownand foreseeablehazards associatedwith eachEN13485:22016management systemdevice;c estimateand evaluatetherisksassociatedwith,and occurringduring,the document.intendeduseand duringreasonably foreseeablemisuse;d eliminateorcontroltherisksreferredto in pointcin accordance with therequirements of Section4;e evaluatethe impact of informationfrom the productionphase and,in particular,from thepost-market surve川ance system,on hazardsand thefrequency of occurrencethereof,on estimatesof theirassociated risks,as well as ontheoverall risk,benefit-risk ratio and riskacceptability;and fbased onthe evaluationof theimpactof theinformation referredto inpointe,if necessaryamend controlmeasures inlinewith therequirements of Section

4.4Risk controlmeasures adopted by manufacturersfor thedesignandmanufacture of the A ENISO14971:2012Risk ManagementReportdevices shallconform tosafety principles,taking accountof thegenerally acknowledgedstateof theart.lb reducerisks,Manufacturers shallmanage risksso thatthe residualrisk EN14126:2003Performance testingreportassociated witheach hazardas wellas the overall residualrisk isjudged acceptable.Inselecting themost appropriatesolutions,manufacturers shall,inthefollowing orderofISO13485qualitypriority:EN13485:2016management systemaeliminateorreducerisksasfaras possible throughsafe designandmanufacture;document.b where appropriate,take adequateprotection measures,including alarmsifnecessary,in relationto risksthat cannot be eliminated;andc provideinformation forsafety warnings/precautions/contra-indications and,where appropriate,training to users.Manufacturers shallinform usersof anyresidual risks.5In eliminatingor reducingrisks related to useerror,themanufacturershall:A ENISO14971:2012Risk ManagementReporta reduce asfaraspossibletherisksrelated tothe ergonomicfeatures of the deviceandthe environment in whichthe device is intendedto beuseddesign for patient safety,EN623662015Usability EvaluationReportandb giveconsideration tothe technicalknowledge,experience,education,training anduseenvironment,whereapplicable,andthemedical andphysical conditionsof intendedusers designforlay,professional,disabled or other users.method;m warningsor precautionsto be taken thatneed to be broughttotheimmediate attentionofthe userof the device,and toany otherperson.This informationmaybekept toa minimuminwhich casemore detailedinformationshallappear inthe instructionsforuse,taking intoaccount theintendedusers;n if the device is intended for singleuse,an indicationof thatfact.A manufacturersindicationof singleuseshallbe consistentacross theUnion;o if the device is asingle-use devicethat has been reprocessed,anindicationof thatfact,thenumber ofreprocessing cyclesalready performed,and anylimitation asregards thenumber ofreprocessingcycles;p ifthe device is custom-made,the wordscustom-made device,;q anindication thatthe device is amedical device.If the deviceis intendedfor clinicalinvestigation only,the words*exclusively forclinical investigation;rinthe caseof devicesthat are composed of substances or of combinations of substancesthatareintendedto be introduced into the human body viaa bodyorifice orapplied tothe skinand thatare absorbed by or locally dispersed inthe human body,the overallqualitativecomposition of thedeviceand quantitative information onthemainconstituent orconstituentsresponsible forachieving theprincipal intendedaction;sforactiveimplantabledevices,theserialnumber,and for other implantabledevices,theserial numberorthelot number.

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3.Information onthepackaging which maintainsthe sterile condition ofa devicesterile A ENISO15223-1:2016Instruction ofUsepackaging1EN1041:2008The followingparticulars shallappearonthe sterile packaging:Labelaan indicationpermitting the sterile packagingto berecognised assuch,ba declarationthatthedeviceisina sterile condition,cthe method of sterilisation,dthe nameand addressofthemanufacturer,ea descriptionofthedevice,f ifthedeviceisintendedforclinicalinvestigations,the words*exclusively forclinicalinvestigations\gif thedeviceiscustom-made,thewordscustom-made device,,hthe monthand yearof manufacture,i anunambiguous indicationofthetimelimitforusingorimplantingthedevicesafelyexpressed atleast intermsofyearandmonth,andj aninstruction tocheck the instructionsforuse forwhat todo ifthesterilepackaging isdamagedor unintentionally opened before use.

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4.Information intheinstructionsforuseA Instruction of UseENISO15223-The instructionsforuseshallcontainall ofthefollowingparticulars:1:2016athe particularsreferredtoin points a,c,e,f,k,1,nandrof Section

23.2;EN1041:2008Labelbthe devicesintendedpurposewithaclear specificationof indications,contra-indications,thepatienttargetgroup orgroups,and oftheintendedusers,as appropriate;cwhere applicable,a specificationoftheclinical benefitsto beexpected.dwhere applicable,links tothe summaryof safety and clinicalperformance referredto inArticle32;ethe performancecharacteristics ofthedevice;f whereapplicable,information allowingthe healthcare professional to verify ifthedeviceissuitable andselect thecorresponding softwareand accessories;gany residual risks,contra-indications and any undesirable side-effects,includinginformation to be conveyedtothepatient inthis regard;hspecifications the user requiresto usethedeviceappropriately,e.g.ifthedevice hasameasuringfunction,the degreeof accuracyclaimed forit;i detailsofanypreparatory treatment or handlingofthedevice beforeit isready foruse orduringits use,such assterilisation,final assembly,calibration,etc.,including thelevels ofdisinfectionrequired toensure patientsafety andall availablemethods forachieving thoselevelsof disinfection;j anyrequirementsfor special facilities,orspecialtraining,or particularqualifications ofthedevice userand/orother persons;k theinformation neededtoverifywhether thedeviceisproperly installedand isready toperformsafelyandasintendedbythemanufacturer,togetherwith,where relevant:—details ofthe nature,and frequency,of preventiveand regularmaintenance,and ofany preparatorycleaningor disinfection,—identification ofany consumablecomponents andhow toreplace them,—information onanynecessarycalibration toensure thatthedeviceoperates properlyandsafely duringits intendedlifetime,and—methods foreliminating therisks encounteredby personsinvolved ininstalling,calibratingor servicingdevices;lif thedeviceis suppliedsterile,instructions intheeventofthesterilepackagingbeingdamaged orunintentionallyopenedbefore use;m ifthedeviceissuppliednon-sterile withthe intentionthat it is sterilisedbeforeuse,theappropriate instructionsfor sterilisation;n ifthedeviceis reusable,information onthe appropriateprocesses forallowing reuse,including cleaning,disinfection,packaging and,where appropriate,the validatedmethod ofre-sterilisation appropriatetotheMember Stateor MemberStates in whichthedevice has beenplaced onthe market.Information shallbeprovidedto identifywhen thedevice shouldno longerbe reused,e.g.signs ofmaterial degradationorthemaximum numberof allowablereuses;oanindication,if appropriate,thatadevicecanbereusedonly ifitisreconditioned under theresponsibility ofthemanufacturerto complywiththegeneral safetyand performancerequirements;p ifthedevicebears anindicationthatitisfor singleuse,information onknowncharacteristics andtechnical factorsknown tothemanufacturerthatcouldpose arisk ifthedevice wereto bere-used.This informationshallbe based ona specificsection ofthemanufacturers riskmanagement documentation,where suchcharacteristicsandtechnicalfactors shallbeaddressedin detail.If in accordancewithpoint dofSection

23.

1.noinstructionsfor use are required,this informationshallbemadeavailabletothe user upon request;qfor devicesintendedforuse togetherwithotherdevicesand/or generalpurpose equipment:—information toidentify suchdevicesorequipment,inorder to obtaina safecombination,and/or一information onany knownrestrictions tocombinations of devicesandequipment;r ifthedeviceemits radiationfor medicalpurposes:—detailedinformationastothenature,type andwhere appropriate,the intensityanddistribution ofthe emittedradiation,—themeansof protectingthepatient,user,orotherperson fromunintended radiationduringuse ofthedevice;s informationthat allowstheuserand/or patientto beinformed ofany warnings,precautions,contraindications,measures to betakenand limitationsofuseregardingthedevice.Thatinformation shall,where relevant,allow theuser tobrief thepatient aboutany warnings,precautions,contra-indications,measures to betakenand limitationsofuseregarding thedevice.Theinformationshall cover,where appropriate:warnings,precautions and/or measuresto betaken intheeventof malfunctionofthedeviceor changesin itsperformance that may affectsafety,—warnings,precautions and/or measuresto betaken asregards theexposure toreasonablyforeseeable externalinfluencesorenvironmental conditions,such asmagnetic fields,externalelectrical andelectromagneticeffects,electrostatic discharge,radiation associatedwithdiagnostic or therapeuticprocedures,pressure,humidity,or temperature,—warnings,precautions and/or measuresto betaken asregards therisksofinterferenceposed bythe reasonablyforeseeable presence ofthedevice duringspecific diagnosticinvestigations,Assessments,ortherapeutictreatmentorother proceduressuch aselectromagneticinterference emittedbythedevice affectingother equipment,ifthedevice isintendedto administermedicinal products,tissues orcells of humanoranimalorigin,or theirderivatives,or biologicalsubstances,any limitationsor incompatibilityinthechoice ofsubstancesto bedelivered,warnings,precautions and/or limitationsrelated tothe medicinalsubstanceor biologicalmaterial thatis incorporated into thedevice asan integralpartofthedevice;and—precautions related to materialsincorporatedinto thedevicethat containor consistof CMRsubstances or endocrine-disrupting substances,or thatcould resultin sensitisationor anallergicreaction bythepatientor user;tinthe caseofdevicesthatare composed of substancesor of combinations of substancesthatareintendedtobeintroduced intothe humanbody and thatareabsorbed byor locallydispersed inthe humanbody,warnings andprecautions,where appropriate,relatedtothegeneral profileof interactionofthedeviceandits productsof metabolismwithotherdevices,medicinal productsandothersubstances as wellascontraindications,undesirable side-effectsand risksrelating tooverdose;u inthe caseof implantabledevices,theoverallqualitative andquantitativeinformation onthe materials and substancesto whichpatients canbe exposed;v warningsor precautionstobetaken inordertofacilitate thesafedisposalofthedevice,itsaccessories andthe consumablesused withit,if any.This informationshall cover,whereappropriate:—infection ormicrobial hazardssuch asexplants,needles orsurgical equipmentcontaminatedwith potentiallyinfectious substancesofhuman origin,and—physical hazardssuch asfrom sharps.If in accordancewiththe pointdofSection

23.1no instructionsforusearerequired,thisinformation shallbemadeavailabletotheuseruponrequest;w fordevicesintendedforusebylaypersons,the circumstancesinwhichtheusershouldconsult ahealthcareprofessional;x for the devicescovered bythis Regulationpursuant to Article12,information regardingtheabsence ofa clinicalbenefit andtherisksrelatedtouseofthedevice;y dateof issueoftheinstructionsforuse or,if theyhave beenrevised,dateofissue andidentifierofthe latest revisionoftheinstructionsforuse;z anotice totheuserand/orpatientthat anyserious incidentthat hasoccurred in relation tothedevice shouldbe reportedtothemanufacturerandthe competentauthority ofthe MemberStateinwhichtheuserand/orpatientis established;aa informationtobesupplied tothepatientwith animplanted devicein accordancewithArticle18;ab fordevicesthatincorporate electronicprogrammablesystems,including software,orsoftware thataredevicesin themselves,minimum requirementsconcerning hardware,ITnetworks characteristicsand ITsecurity measures,including protectionagainst unauthorisedaccess,necessary torun thesoftware asintended.6The characteristicsandperformanceofadevice shallnotbeadversely affectedtosuchA ENISO15223-1:2016a degreethatthehealth orsafetyofthepatientortheuserand,whereapplicable,of otherLabelInstruction ofUsepersons arecompromised duringthe lifetimeofthedevice,asindicatedbytheENISO14971:2012manufacturer,whenthedeviceissubjected tothe stresseswhich canoccur duringRisk Management Reportnormalconditionsofuseandhasbeenproperly maintainedin accordancewith theISO10993-1:2018manufacturers instructions.ENISO10993-5:2009BiocompatibilityENISO10993-10:2013Assessment ReportEN14126:2003Performance testingreport7Devices shallbe designed,manufactured andpackaged insuchawaythattheir A ENISO14971:2012Risk ManagementReportcharacteristics andperformance duringtheir intendedusearenot adverselyaffectedduring transport and storage,for example,through fluctuationsof temperatureand EN14126:2003humidity,takingaccount oftheinstructionsandinformationprovided bythemanufacturer.Performance testingreportEN ISO11135:2014Sterilization ValidationReportPackingProtectionTesting Report8AENISO14971:2012Risk ManagementReportAll knownand foreseeablerisks,andanyundesirableside-effects,shallbeminimisedand beacceptable whenweighed againstthe evaluatedbenefitstothepatientand/oruser arisingfrom theachievedperformanceof thedeviceduringnormal conditionsofuse.9For the devices referredtoin Annex XVI,thegeneralsafety requirementsset outin NAENISO14971:2012Risk ManagementReportSections1and8shallbeunderstood tomean thatthedevice,when usedunder theconditions and forthe purposesintended,does notpresent arisk atall orpresents ariskthat isno morethan themaximum acceptablerisk relatedtotheproducts usewhich isconsistentwithahigh levelof protectionforthesafetyandhealth ofpersons.REQUIREMENTS REGARDINGDESIGN ANDMANUFACTURE10Chemical,physical and biological properties

10.

1.Devices shallbedesignedandmanufacturedinsuchawayastoensurethatthe AENISO15223-1:2016LabelIFUcharacteristics andperformance requirementsreferredtoin ChapterI arefulfilled.Particular attentionshallbepaid to:ISO10993-1:2018a thechoice ofmaterials and substances used,particularly asregards toxicityand,BiocompatibilityENIS010993-5:2009where relevant,flammability;b thecompatibility betweenthe materialsandsubstancesAssessment ReportENISO10993-10:2013used andbiological tissues,cells andbody fluids,taking accountoftheintendedpurpose ofthedeviceand,where relevant,absorption,distribution,metabolism andEN14126:2003Performance testingreportexcretion;c thecompatibility betweenthe differentpartsofadevicewhich consistsofmore thanone implantablepart;dtheimpactofprocesses onmaterial properties;ewhere appropriate,the resultsof biophysicalor modellingresearch thevalidity ofwhichhas beendemonstrated beforehand;fthemechanical propertiesofthematerials used,reflecting,where appropriate,matters suchas strength,ductility,fracture resistance,wear resistanceand fatigueresistance;g surfaceproperties;andh theconfirmationthat thedevice meetsany definedchemical and/or physicalspecifications.

10.

2.Devices shallbedesigned,manufactured andpackaged insuchawayastoALabelInstruction ofUseENISO15223-1:2016minimise therisk posed by contaminants and residuesto patients,taking accountof theEN1041:2008intendedpurpose ofthedevice,and tothepersonsinvolved inthe transport,storageanduse ofthe devices.Particular attentionshallbepaid totissues exposedto thoseENISO14971contaminantsandresidues andtotheduration andfrequencyofexposure.Risk managementreportISO10993-1:2018BiocompatibilityENIS010993-5:2009Assessment ReportENISO10993-10:

201310.

3.Devices shallbedesignedandmanufacturedinsuchawaythat theycanbeused NA/This devicew川not contactsafelywiththematerialsandsubstances,including gases,with whichthey enterinto withmedicinal products.contact duringtheir intendeduse;ifthedevices areintendedtoadminister medicinalproductsthey shallbedesignedandmanufacturedinsuchawayastobe compatiblewiththemedicinal products concernedin accordancewiththeprovisions andrestrictionsgoverning thosemedicinal productsand thattheperformanceof boththe medicinalproductsand ofthedevicesis maintainedinaccordancewith theirrespective indicationsandintendeduse.

10.

4.Substances f//

10.

4.

1.Design andmanufacture ofdevices N/A Nopresence of CMRDevices shallbedesignedandmanufacturedinsuchawayastoreduceasfaraspossible endocrinedisruptingthe risksposedbysubstancesorparticles,including weardebris,degradation productsandsubstance.processing residues,thatmaybe releasedfrom thedevice.Devices,orthose parts thereof orthosematerialsused therein that:—are invasiveand come into directcontact withthe humanbody,—readminister medicines,body liquidsorothersubstances,including gases,to/fromthe body,or—transport orstore suchmedicines,body fluidsorsubstances,including gases,tobereadministered tothebody,shall onlycontain thefollowing substancesin aconcentrationthatisabove0,1%weight byweight w/w wherejustified pursuantto Section

10.

4.2:a substanceswhich arecarcinogenic,mutagenic ortoxic toreproduction CMR,of category1Aor1B,inaccordancewith Part3ofAnnexVI toRegulation EC No1272/2008oftheEuropean Parliamentand ofthe Council1,orsubstanceshaving endocrine-disrupting propertiesfor whichthere isscientific evidenceof probableseriouseffects to human healthand whichare identifiedeither inaccordancewiththe procedureset outin Article59of RegulationECNo1907/2006oftheEuropeanParliament andoftheCouncil2or,once adelegated acthasbeenadoptedbythe Commissionpursuanttothe firstsubparagraph of Article53of RegulationEUNo528/2012oftheEuropean ParliamentandtheCouncil3,inaccordancewiththe criteria thatare relevanttohumanhealth amongstthecriteriaestablished therein.NA//

10.

4.

2.Justification regardingthe presenceofCMRand/or endocrine-disrupting substancesThejustification forthe presenceof such substances shallbebasedupon:aan analysisand estimationof potentialpatientoruser exposuretothe substance;ban analysisof possiblealternative substances,materials ordesigns,including,whereavailable,information aboutindependent research,peer-reviewed studies,scientific opinionsfromrelevant scientific committees andan analysisoftheavailability of such alternatives;cargumentation asto whypossible substanceand/or materialsubstitutes,if available,ordesign changes,if feasible,are inappropriateinrelationto maintainingthe functionality,performance andthebenefit-risk ratiosoftheproduct;including takingintoaccountif theintendeduseofsuchdevices includes treatment of children or treatment of pregnantorbreastfeeding women or treatmentof other patient groups considered particularlyvulnerable tosuchsubstances and/or materials;anddwhere applicableand available,thelatestrelevant scientificcommittee guidelinesinaccordance withSections

10.

4.

3.and

10.

4.

4.

10.

4.

3.Guidelines onphthalates NA/No phthalates.For thepurposes ofSection

10.

4.,the Commissionshall,as soonaspossibleand by26May2018,provide the relevant scientificcommittee witha mandateto prepareguidelines thatshallbe readybefore26May

2020.The mandateforthecommittee shallencompass atleast abenefit-risk assessmentofthe presenceofphthalates whichbelong toeither ofthe groupsofsubstances referredtoinpoints aandbofSection

10.

4.

1.The benefit-risk assessmentshalltake intoaccounttheintendedpurposeand contextoftheuseofthedevice,aswellas anyavailablealternative substancesand alternativematerials,designs ormedical treatments.When deemedappropriate onthe basisofthelatest scientificevidence,but atleast everyfiveyears,the guidelinesshallbeupdated.NA/No other CMR andendocrine-disrupting

10.

4.

4.Guidelines onotherCMRand endocrine-disrupting substancessubstancesSubsequently,the Commissionshall mandatetherelevantscientificcommitteeto prepareguidelinesas referredtoinSection

10.

4.

3.alsofor othersubstances referredtoinpoints aandb ofSection

10.

4.

1.,where appropriate.

10.

4.

5.Labelling NA/No abovesubstances.Wheredevices,partsthereofor materialsusedthereinas referredtoinSection

10.

4.

1.containsubstancesreferredto inpointsaorbofSection

10.

4.

1.inaconcentration above0,1%weight byweightw/w,thepresenceofthosesubstances shallbe labelledonthedevice itselfand/oronthepackaging foreach unitor,whereappropriate,onthesales packaging,withthelist ofsuchsubstances.If theintendeduseofsuchdevicesincludestreatmentofchildrenortreatment ofpregnantor breastfeedingwomenortreatmentofotherpatientgroupsconsideredparticularlyvulnerable tosuchsubstancesand/or materials,informationonresidualrisksfor thosepatientgroups and,if applicable,onappropriateprecautionary measuresshallbegiven intheinstructions foruse.

10.

5.Devices shallbedesignedandmanufacturedinsuchawayastoreduceasfarasAENISO14971:2012Risk ManagementReportpossible therisksposedbytheunintentional ingressof substancesintothedevice takingintoaccountthedeviceandthenatureoftheenvironmentinwhichitisintendedtobeused.

10.

6.Devices shallbedesignedandmanufacturedinsuchawayastoreduceasfarasAENISO14971:2012Risk ManagementReportpossible therisks linkedtothesize andthe propertiesof particleswhichareor canbe releasedintothe patientsor usersbody,unless theycomeintocontact withintact skinonly.Specialattentionshall begiven tonanomaterials.

1111.Infection andmicrobial contamination

11.

1.Devices andtheir manufacturingprocesses shallbedesignedinsuchawayastoAENISO14971:2012RiskManagementReporteliminate ortoreduceasfaraspossibletheriskof infectionto patients,users and,whereapplicable,other persons.The designshall:a reduceasfaraspossibleandappropriatetherisks fromunintendedcutsandpricks,suchasneedlestickinjuries,b alloweasy andsafehandling,c reduceasfaraspossibleany microbialleakage fromthedeviceand/or microbialexposureduring use,and preventmicrobial contaminationofthedevice orits contentsuch asspecimensor fluids.

11.

2.Where necessarydevicesshallbedesignedtofacilitatetheirsafecleaning,disinfection,AENISO15223-1:LabelInstructionofUseand/orre-sterilization.2016EN1041:2008Sterilization ValidationReportEN ISO11135:2014AENISO11135:2014Sterilization ValidationReport

11.

3.Devices labelledas havingaspecificmicrobial stateshallbedesigned,manufactured andpackagedtoensurethat they remain inthat statewhen placedonthemarket andremain sounderthetransportand storage conditions specified bythemanufacturer.

11.

4.Devices deliveredinasterile stateshallbedesigned,manufactured andpackaged inAENISO11135:2014Sterilization ValidationReportaccordance withappropriate procedures,toensurethat theyare sterilewhen placedon themarketandthat,unless thepackagingwhichisintendedto maintaintheir sterilecondition isdamaged,theyremainsterile,underthetransportandstorageconditionsspecifiedbythemanufacturer,until thatpackaging isopened atthe pointofuse.It shallbe ensuredthat theintegrityof thatpackaging isclearly evidenttothefinal user.

11.

5.Devices labelledas sterileshallbeprocessed,manufactured,packaged and,sterilized byAENISO11135:2014Sterilization ValidationReportmeans ofappropriate,validatedmethods.

11.

6.Devicesintendedtobesterilized shallbe manufacturedandpackagedin appropriateandA ISO14644-1Cleaning Roomcontrolledconditionsandfacilities.ISO14698-1/-2NA/Not needtobesterilized prior

11.

7.Packaging systemsfor non-sterile devicesshall maintainthe integrityand cleanlinessofuse.theproductand,wherethedevicesaretobesterilized priortouse,minimize theriskofmicrobialcontamination;thepackagingsystemshallbe suitabletaking accountofthemethod ofsterilizationindicatedbythemanufacturer.

11.

8.The labellingofthedevice shalldistinguish betweenidentical orsimilar devicesplaced onNAEN980:2008Labelthe marketin bothasterileandanon-sterileconditionadditional tothe symbolused toindicatethat devicesare sterile.12Devices incorporatinga substanceconsidered tobeamedicinal productanddevices thatarecomposedofsubstancesorofcombinationsofsubstances thatareabsorbed byor locallydispersedinthehumanbody.

12.

1.In thecaseofdevices referredtointhe firstsubparagraph ofArticle18,the quality,NA/Not amedicinal product.safetyandusefulness ofthesubstancewhich,if usedseparately,would beconsideredtobe amedicinalproduct withinthe meaningof point2ofArticle1of Directive2001/83/EC,shall beverifiedby analogywiththemethods specifiedin AnnexI toDirective2001/83/EC,as requiredbythe applicable conformity assessmentprocedure underthis Regulation.

12.

2.Devicesthatarecomposedofsubstancesorofcombinationsofsubstances thatare NA/Not amedicinalproduct.intendedtobeintroducedintothehumanbody,andthatareabsorbedbyorlocallydispersedinthe humanbody shallcomply,whereapplicableandina mannerlimited tothe aspectsnotcovered bythis Regulation,withtherelevant requirements laiddown inAnnexI toDirective2001/83/EC forthe Assessmentof absorption,distribution,metabolism,excretion,localtolerance,toxicity,interaction withotherdevices,medicinal productsorothersubstances andpotentialfor adversereactions,as requiredbytheapplicableconformityassessment procedureunderthisRegulation.

13.Devices incorporatingmaterials of biological origin

13.

1.For devicesmanufactured utilisingderivatives oftissues orcells ofhumanoriginwhich NA/The devicedont incorporatearenon-viable orarerenderednon-viable coveredby thisRegulationin accordancewithpoint materialsofbiologicalorigin.gofArticle16,thefollowingshallapply:adonation,procurement andtesting ofthetissuesand cellsshallbedone inaccordance withDirective2004/23/EC;bprocessing,preservation andanyotherhandlingofthose tissuesandcellsor theirderivativesshallbecarriedoutsoastoprovidesafetyfor patients,users and,whereapplicable,otherpersons.In particular,safety withregard toviruses andothertransmissibleagentsshallbeaddressed byappropriate methodsof sourcingandbyimplementation ofvalidatedmethodsofelimination orinactivationinthecourseofthemanufacturingprocess;cthe traceabilitysystem forthose devicesshallbecomplementary andcompatiblewiththetraceability anddata protectionrequirementslaiddownin Directive2004/23/EC andinDirective2002/98/EC.。