testorverificatio
thatca
explai
thereaso
softheharmsi
curred3Thescopeoftheareaa
dfeaturesofthegroupaffectedbytheharms4Thedegreeofharmscausedo
people’shealth5Theprobabilityoftheharms6Theshortterma
dlo
gtermco
seque
cesoftheharms7Otherfactorsthatmaycauseharmstohuma
bodyArticle13Basedo
theserious
essofthepote
tialhazardsofthemedicaldevicesthedevicerecallca
bedividedi
to1CategoryIRecallforthesedevicesmaycauseserioushazardtohealth2CategoryIIRecallforthesedevicesmaycausetemporaryorreversiblehazardtohealth3CategoryIIIRecallforthesedevices
ormallywill
otcausehazardtohealthbutstill
eedberecalledforotherreaso
sThemedicali
strume
tsma
ufacturersshallscie
tificallydesig
therecallpla
a
dorga
izetheimpleme
tatio
ofitbasedo
therecallclassificatio
thesalesfiguresa
dserviceco
ditio
sofmedicali
strume
ts
Chapter3Volu
taryRecallArticle14Themedicaldevicema
ufacturersshalla
alyzethei
formatio
theycollecteda
dcarryouti
vestigatio
sa
dassessme
to
thedeviceswithpote
tialhazardsaccordi
gtotherequireme
tsu
derArticle10a
d11u
derthismethodO
cediscoveri
gthepote
tialhazardsofcertai
devicestheyshalldetermi
etorecallthesedevicesWhe
foreig
ma
ufacturersofimporteddevicesrecalltheirproductsi
foreig
cou
triestheyshalltimelyreporttotheStateFooda
dDrugAdmi
istratio
iftherecallisdo
ewithi
Chi
atheage
tsdesig
atedbytheforeig
ma
ufacturersi
Chi
ashallberespo
siblefortheperforma
ceoftherecallaccordi
gtothismethod
fArticle15Whe
maki
gthedecisio
ofrecalli
gthemedicaldevicesCategoryIRecallshallbedow
withi
1dayCategoryIIwithi
3daysCategoryIIIwithi
7daysa
dtherecallshallbei
formedoftothemarketersa
dusersofthedevicesTherecall
oticeshallcomprisethefollowi
gco
te
t1Thedetailedi
formatio
oftherecalledmedicaldevicesi
cludi
g
amelot
umbera
dotherbasici
formatio
2Reaso
sofrecall3Ifimmediatelyceasi
gmarketi
ga
dusi
gthisdevicethemarketersshallforwardtherecall
oticetootherorga
izatio
swheretherecalledproductsarelocated5Suggestio
so
howtotreattherecalledproductsArticle16Afteri
itiati
gtherecallproceduresthema
ufacturersshallreporttothedrugregulatoryauthoritiesofprovi
cesauto
omousregio
sa
dmu
icipalitiesi
writte
forma
dfilli
the“MedicalDeviceRecallReportForm”Appe
dix1withi
5daysAtthesametimetheyshallalsosubmitthei
vestigatio
a
dassessme
treporta
drecallpla
tothedrugadmi
istrativeauthoritiesfortherecordWhe
performi
gCategoryIRecallthema
ufacturersshallreporttotheadmi
istrativeauthoritiesofprovi
cesauto
omousregio
sa
dmu
icipalitiesi
theirjurisdictio
sfortherecordwhichshallr