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RAC device quiz questions with correct answers
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RAC device quiz questions with correct answers
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RAC device quiz questions with correctanswers
EU: iiWhich iiof iithe iifollowing iidoes iiNOT iidescribe iithe iiCE iiMark iior iiits iiuse?
A)The iiCE iiMark iiis iian iiexternal iiindication iithat iia iidevice iimeets iithe iiEssential
iiRequirements
B)The iimanufacturer iiand/or iithe iiNotified iiBody iihave iichecked iithe iidevice iiagainst
iispecifications iiusing iia iiConformityAssessment iiProcedure
C) iiA iiDeclaration iiof iiConformity iihas iibeen iiproduced iiby iithe iimanufacturer
D) iiThe iiCE iiMark iiallows iithe iidevice iito iimove iifreely iithroughout iiEurope iionly ii-
iiAnswers ii-D) iiThe iiCE iiMark iiallows iithe iidevice iito iimove iifreely iithroughout iiEurope
iionly
EU: iiThe iifollowing iiare iicomponents iiof iiroutine iirisk iiminimisation iiEXCEPT:
A)Adding iiprotective iimeasures iiin iithe iimanufacturing iiprocess
B) iiApplication iiof iirelevant iistandards
C) iiAn iievaluation iiof iithe iineed iifor iirisk iiminimisation iiactivities
D) iiA iimarketing iiplan ii- iiAnswers ii-D) iiA iimarketing iiplan
EU: iiClassification iiof iimedical iidevices iiis iibased iiupon iiall iiof iithe iifollowing iiEXCEPT
iithe:
A) iiDevice's iiintended iipurpose
B) iiDevice's iiimplantability
C) iiDevise iiinvasiveness
D) iiDevice's iiindications iifor iiuse ii- iiAnswers ii-D) iiDevice's iiindications iifor iiuse
Note: iiMDR iiChapter iiV iiArticle ii51: ii"Devices iishall iibe iidivided iiinto iiclasses iiI, iiIIa, iiIIb
iiand iiIII, iitaking iiinto iiaccount iithe iiintended iipurpose iiof iithe iidevices iiand iitheir iiinherent
iirisks"
EU: iiWhich iiof iithe iifollowing iidoes iiNOT iidescribe iia ii"custom iidevice" ii?
A) iiIt iiis iimade iispecifically iiin iiaccordance iiwith iia iiduly iiqualified iimedical iipractitioner's
iiwritten iiprescription, iiwhich iigives iispecific iidesign iicharacteristics
B) iiThe iimanufacturer iiand/or iithe iiNotified iiBody iihave iichecked iithe iidevice iiagainst
iispecifications iiusing iia iiConformity iiAssessment iiProcedure
C) iiIt iiis iiintended iifor iithe iisole iiuse iiof iia iiparticular iipatient
, D) iiThe iidevice iicannot iiexhibit iithe iiCE iiMark iito iimove iifreely iithroughout iiEurope ii-
iiAnswers ii-B) iiThe iimanufacturer iiand/or iithe iiNotified iiBody iihave iichecked iithe iidevice
iiagainst iispecifications iiusing iia iiConformity iiAssessment iiProcedure
MDR: ii'custom-made iidevice' iimeans iiany iidevice iispecifically iimade iiin iiaccordance
iiwith iia iiwritten iiprescription iiof iiany iiperson iiauthorised iiby iinational iilaw iiby iivirtue iiof
iithat iiperson's iiprofessional iiqualifications iiwhich iigives, iiunder iithat iiperson's
iiresponsibility, iispecific iidesign iicharacteristics, iiand iiis iiintended iifor iithe iisole iiuse iiof iia
iiparticular iipatient iiexclusively iito iimeet iitheir iiindividual iiconditions iiand iineeds.
Your iiUS-based iicompany iihas iia iimedical iidevice iimanufacturing iisite iiin iithe
iiNetherlands. iiIt iiwishes iito iirelocate iithat iifacility iito iiBelgium. iiWhich iiof iithe iifollowing
iiBEST iidescribes iithe iiactions iirequired?
A) iiNo iiregulatory iiactions iiare iirequired iito iimove iifacilities iiwithin iithe iiEU
B) iiA iisite iiaudit iiof iithe iinew iifacility iibased iion iiISO ii13485:2003 iirequirements iiwill iibe
iinecessary iito iiensure iithe iiEssential iiRequirements iicontinue iito iibe iimet
C) iiProduct iilabelling iirevisions iimay iibe iirequired
D) iiYou iimust iiobtain iinew iiCertificates iiof iiFree iiSale iifrom iiBelgium iito iiship iiproduct
iifrom iithe iinew iifacility iito iiother iiEU iicountries ii- iiAnswers ii-B) iiA iisite iiaudit iiof iithe iinew
iifacility iibased iion iiISO ii13485:2003 iirequirements iiwill iibe iinecessary iito iiensure iithe
iiEssential iiRequirements iicontinue iito iibe iimet
The iidevelopment iiteam iiapproaches iiyou iiconcerning iithe iiregistration iistrategy iiand
iimarketing iiapplication iifor iia iicombination iiproduct iiinvolving iiinhaled iidevice iidelivery
iiof iia iismall iimedicinal iimolecule. iiIn iithe iiUS, iithis iiproduct iiwill iibe iitreated iias iia iidrug
iiand iisubmitted iiin iia iiNew iiDrug iiApplication ii(NDA). iiIn iiEurope, iithe iiregistration
iiapproach iimay iiinclude iiall iiof iithe iifollowing iiEXCEPT iia:
A) iiCE iiMark iifor iithe iidevice iiand iian iiapplication iiunder iia iiMutual iiRecognition
iiAgreement ii(MRA) iior iithe iiCentralised iiProcedure iifor iithe iidrug
B) iiDesign iidossier iiand iiCE iiMark iifor iithe iientire iicombination iiproduct
C) iiTechnical iifile iifor iithe iidevice iireferenced iiin iithe iiMRA iior iiCentralised iiProcedure
D) iiSingle iiMRA iior iiCentralised iiProcedure iiapplication iifor iithe iicombination ii- iiAnswers
ii-B) iiDesign iidossier iiand iiCE iiMark iifor iithe iientire iicombination iiproduct
As iiin iithe iiUS, iithe iiprincipal iimode iiof iiaction iiwould iigovern iiproduct iiregulatory iistatus.
iiIn iithis iicase, iias iithe iidelivery iidevice's iiaction iiis iiancillary iito iithat iiof iithe iimedicinal
iiproduct iito iibe iiinhaled, iithe iisponsor iicould iinot iiCE iiMark iithe iicombination iiand iiplace
iiit iion iithe iimarket iiin iithe iiEEA.
Centralised iiprocedure: iiThe iiEuropean iiUnion-wide iiprocedure iifor iithe iiauthorisation iiof
iimedicines, iiwhere iithere iiis iia iisingle iiapplication, iia iisingle iievaluation iiand iia iisingle
iiauthorisation iithroughout iithe iiEuropean iiUnion. iiOnly iicertain iimedicines iiare iieligible
iifor iithe iicentralised iiprocedure.
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