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Conformityassessmentproceduresfor3Dprintingand3Dprintedproducts
tobeusedinamedicalcontextforCOVID-19
Q1:IsthereanyapplicableEUlegalframeworksinthecaseof3Dprinting?
3DPrinting(3DP)–alsoknownasAdditiveManufacturing(AM)-isamanufacturingprocessthat
uses3DPrinters–alsoknownasAdditiveManufacturingmachinery-tofabricateothermarket
products.
3DPrinters–alsoknownasAdditiveManufacturingmachineryaremeansofproductionthatcanbeusedtomanufacturevariousproductsfordifferentapplications.
3Dprintersareamongtheso-called‘harmonisedproducts’forwhichthereisspecificEUproduct
harmonisationlegislationinplace.Inparticular,theyfallunderthedefinitionofmachineryunderthe
Machinery
Directive
2006/42/EC
.
Thus,manufacturersmustensurethecomplianceof3DPrinters
withtheapplicableessentialhealthandsafetyrequirementsoftheMachineryDirective,composea
technicalfileandaffixtheCE-markingbeforeplacingthemontheEUinternalmarket.
BesidestheMachineryDirective,otherEUpiecesoflegislationmayapplyto3Dprinters;i.e.the
Electromagnetic
Compatibility
Directive
2014/30/EC
,
andEUlegislationonchemicals,
WEEE
2012/19/EU
,
RoHS
II
2011/65/EU
Directive
and
Directive
(EU)
2017/2102
,
and
REACH
1907/2006/EU
.
ProductsdesignedandmanufacturedinaccordancewiththeMachineryDirective2006/42/ECcan
circulatefreelythroughouttheinternalmarketandMemberStatesmaynotintroduceadditional
and/ordivergingrequirementsregardingthemanufacturingandplacementonthemarketofsuch
products.
3Dprintedproductsinthemselvesmaybeusedtoproducemedicaldeviceswhichfallwithinthe
scopeofspecificEUproductlegislation,suchastheMedicalDevicesDirective93/42/EEC1.Therefore,
manufacturersofsuchmedicaldevicesmustensurethat3Dprintedproductsmeettherequirements
oftheapplicableEUlegislation2,carryoutthenecessaryconformityassessmentprocedures,
composeatechnicalfile,drafttheEUdeclarationofconformityandaffixtheCEmarking,before
placingthemontheEUmarket3.(cf.questionsbelow)
1Pleasenotethatwhenthenew
Regulation
(EU)
2017/745
entersintofullapplication,itwillreplacethe
Directive93/42/EEC.However,accordingtothetransitionalprovisionsofArt.120ofthatRegulation,devices
compliantwithDirectivecancontinuetobeplacedonthemarketundercertainconditionsandinaccordance
withcertaintimelines.
2Currently,medicaldevicesareruledbyDirective93/42/EEC,concerningmedicaldevices;Directive98/79/EC
oninvitrodiagnosticmedicaldevicesandDirective90/385/EECrelatingtoactiveimplantablemedicaldevices.
3FormoreinformationontheproductcoverageofEUproductlegislationandtheCEmarking,see:
https://ec.europa.eu/growth/single-market/ce-marking/
1
Q2:ArethereanymandatoryEUstandardsfor3Dprinters?
Concerningthe3Dprinter,themanufacturerofmachineryorhisauthorisedrepresentativemust
ensurethatariskassessmentiscarriedoutinordertodeterminethehealthandsafetyrequirements
whichapplytothemachinery.Themachinerymustthenbedesignedandconstructedtakinginto
accounttheresultsofsuchriskassessment.
TheMachineryDirective2006/42/EClaysdownessentialrequirementsonhealth,safetyand
performanceoftheproductstheycover.However,thisEUlegalframeworkistechnologicallyneutral
anddoesnotprescribeanyspecificmandatorytechnicalsolutionsforthedesignoftheproducts.
Therefore,anumberoftechnicalsolutionsmaybeusedbymanufacturerstomeettheseessential
requirements.
TheMachineryDirectiveoffersthepossibilityformanufacturerstorelyonspecifictechnical
solutions,whicharedetailedinharmonisedEuropeanstandardsorpartsthereofthereferencesof
whichhavebeenpublishedintheOfficialJournaloftheEuropeanUnion(OJEU).Shoulda
manufacturerchoosetoadoptsuchatechnicalsolution,theproductispresumedtobeinconformity
withtheapplicableessentialhealth,safetyandperformancerequirementsthattheharmonised
standardaimtocover.Otherwise,ifthemanufacturerchoosetoadoptanyothertechnicalsolution,
(s)hemustgiveadetailedexplanationonthecomplianceofsuchtechnicalsolutionwiththeEU
legislationrequirementsinthetechnicalfile.
ThefollowingaresomeofthemostrelevantharmonisedstandardscitedintheOJEUundertheMachineryDirective4forlaser-based3Dprinters(metal):
ENISO12100(Safetyofmachinery–Generalprinciplesfordesign–Riskassessmentandrisk
reduction)
EN60204-1(Safetyofmachinery–Electricalequipmentofmachines)
EN13849-1(Safetyofmachinery–Safety-relatedpartsofcontrolsystems)
EN13850(Safetyofmachinery–Emergencystopfunction–Principlesfordesign)
ENISO11553-1(Laserprocessingmachines)
EN1127-1(Explosiveatmospheres–Explosionpreventionandprotection)
ENISO19353(Safetyofmachinery–Firepreventionandfireprotection)
Forplasticprinters,fireandexplosionstandardsarerelevanttoo.
Inaddition,itisusefultoconsidersomenon-harmonisedstandardsforlaserproducts/safety;
EN60825-1(Safetyoflaserproducts–Part1:Equipmentclassificationandrequirements)
EN60825-4(Safetyoflaserproducts–Part4:Laserguards)
Q3:IsthereanyapplicableEUlegalframeworkfor3Dprintedproductsusedinamedicalcontext?
Dependingontheintendedpurposeofthe3Dprintedproduct,theymayqualifyasmedicaldevices,
oraccessoriesaccordingtothedefinitionssetoutinthemedicaldeviceslegislation.Suchproducts
4Harmonisedstandardsformachiner
y:
https://ec.europa.eu/growth/single-market/european-
standards/harmonised-standards/machinery
2
mustfulfilallapplicablerequirementsof
Directive
93/42/EEC
5
.Inparticular,accessoriesofmedical
devices(whicharenotinthemselvesmedicaldevices),butareintendedbythemanufacturertobe
usedspecificallytoenabletheuseofamedicaldevice,mayqualifyasdevicesandshallmeetthe
requirementsofthemedicaldeviceslegislation.Thisisnotnecessarilythecaseforpartsand
componentsofmedicaldevices,whichdon’thaveregulatorystatusundertheMedicalDevices
Directive93/42/EEC,howeverarenonethelessexpectedtosatisfythesafetyrequirementsofa
medicaldevice,beingpartthereof.
Forexample,3Dprintedplasticvalvesusedinrespiratoryventilatorsmayqualifyaseither
accessoriesofmedicaldevicesortheirpartsandcomponents.
WheretheconformityassessmentprocedureforthemedicaldeviceisbasedontheManufacturers’QualityManagementSystem,thefollowingharmonizedstandardmaybeused:
ENISO13485:2016Medicaldevices-Qualitymanagementsystems-Requirementsfor
regulatorypurposes(ISO13485:2016)ENISO13485:2016/AC:2018
Accordingtosuchstandard,themanufacturershouldvalidatetheproductionprocessassetoutin
section7.5.6ENISO13485:2016.Amongotherrequirements,thevalidationprocedureshouldalso
includetheequipmentqualification.
Harmonisedstandardsonadditivelymanufacturedpartstobeusedinthemedicaldevicessector.
Therearenoharmonisedstandardsthatspecificallyapplytoadditivelymanufacturedparts
tobeusedinthemedicaldevicessector.However,otherstandardsmaybeused.6
Existingsafetystandardsrelatedtothemanufacturinganduseofthespecific
part/componentinthemedicaldevicessectorareapplicableregardlessofthetypeof
machine/processusedfortheirproduction.
Itisimportanttochoosethecorrectmaterialstodeveloptheneededpartsorcomponents
(hecaseofventilatorvalves,compatibilitytestingbetweenthematerialandthe
enrichedoxygenfluidtobeadministered,shouldbeperformed)
Itisimportanttoapplyappropriatepost-processes(e.g.cleaning,sterilisation,biological
evaluation)tothemanufacturedparttoensuretheabsenceofloosepowderparticlesand
anyotherpotentiallyharmingelements.
OtherspecificrequirementslaiddownintheEUlegislationonmedicaldevicesareaddressed
bystandards,suchasstandardsontheinformationtobesuppliedbythemanufacturer,on
medicalelectricalequipment,etc.
Otherthanharmonisedstandards,designspecificationsforspecificdevicesanddeviceparts,
componentsoraccessoriescanbeacquiredeitherthroughanagreementwithanexistingmedical
devicemanufacturerorthoughcontactinganationalcompetentauthority.7
5Directive93/42/EEC.Seealsofootnote1,regardingthenewRegulation(EU)2017/745.
6SeeISOISO/ASTM52901:2017[ASTMF42]
/standard/67288.html
7Contactinformationcanbefoundonthemedicaldevicessectorial
website
oftheEuropeanCommission.
3
ListofarecentlypublishedlistofharmonisedstandardsundertheMedicalDevicesDirective
relevantforventilatorparts,componentsandaccessories
ENISO17510-1:2009Sleepapnoeabreathingtherapy-Part1:Sleepapnoeabreathing
therapyequipment(ISO17510-1:2007)
ENISO17510-2:2009Sleepapnoeabreathingtherapy-Part2:Masksandapplication
accessories(ISO17510-2:2007)
EN12342:1998+A1:2009Breathingtubesintendedforusewithanaestheticapparatusand
ventilators
ENISO8835-3:2009Inhalationalanaesthesiasystems-Part3:Transferandreceivingsystems
ofactiveanaestheticgasscavengingsystems(ISO8835-3:2007)ENISO8835-3:2009/A1:201
ENISO5366-1:2009Anaestheticandrespiratoryequipment-Tracheostomytubes-Part1:
Tubesandconnectorsforuseinadults(ISO5366-1:2000)
ENISO7376:2009Anaestheticandrespiratoryequipment-Laryngoscopesfortracheal
intubation(ISO7376:2009)
EN13544-1:2007+A1:2009Respiratorytherapyequipment-Part1:Nebulizingsystemsand
theircomponent
EN13544-2:2002+A1:2009Respiratorytherapyequipment-Part2:Tubingandconnectors
Issuesrelatedtothematerialused
Itisessentialthatthematerialus
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