Nga 28 th .April 2022, Joytech yafuna okufulumya okusooka okwa EU MDR ku ba non-invasive blood pressure monitors zaffe,osobola okumanya ebisingawo wano.
Mu mwaka gwa 2023, ebipima ebbugumu ebya Joytech contact, non contact thermometers n’ebyuma ebipya ebikebera puleesa byonna bikkirizibwa EU MDR.
CE(MDR) kye ki?
Bwe kituuka ku satifikeeti za CE, buli omu azimanyidde.Kumpi buli mulimu gulina satifikeeti ya CE ekwatagana nayo.MDR kifupi kya European Medical Device Regulation, nga kino kye kitereeza CE (MDD) era nga kiteeka ebisaanyizo eby’amaanyi ku bukuumi n’enkola y’ebyuma eby’obujjanjabi.Era tugiyita CE(MDR).
Njawulo ki eriwo wakati wa CE(MDD)ne CE(MDR)?
MDR kiragiro ate MDD kiragiro.Olw’okuba nti nnongoosereza, okuva ku biragiro okutuuka ku biragiro, amawanga agali mu mukago gwa EU gajja kufuga nnyo enkola y’okugaba satifikeeti n’ebivaamu.
Okusinga kyeyolekera mu bintu bino wammanga:
1) Yanyweza obuvunaanyizibwa bw’omukozi.
a) Omukozi alina okuba n’omukungu omu avunaanyizibwa ku kugoberera amateeka alina obukugu mu by’obujjanjabi (tewali kyetaagisa kya lwatu mu kiragiro kya MDD);
b) Omukozi alina okuteekawo n’okutereeza buli kiseera ebiwandiiko eby’ekikugu n’okukakasa nti biriwo nga bisabiddwa ekitongole ky’eggwanga ekivunaanyizibwa.
c) Abakola ebintu balina okwanukula okukeberebwa okutalangiriddwa okukolebwa ebitongole ebitegeezeddwa ekiseera kyonna okukakasa nti ebiwandiiko eby’ekikugu bitereezebwa n’okuddaabiriza enkola;(Ebintu ebya kiraasi II)
d) Ku bintu eby’akabi ennyo ebya kkampuni ezisuubula, kijja kuba kizibu okusaba CE.
2) Okwongera ku biragiro ebifuga n’okuddamu okwetegereza satifikeeti okukakali.
a) Okwongera ku mateeka g’okugabanya: okuva ku 18 mu MDD okutuuka ku 22 mu MDR;
b) Ebintu eby’olukalala lw’okukebera ebyetaago ebikulu byongerwako: okuva ku bintu 13 mu MDD okutuuka ku bintu 23 mu MDR;
c) Ensengeka y’ebiwandiiko eby’ekikugu ebya CE ekyuse era egabanyizibwamu: ebiwandiiko eby’ekikugu eby’ebintu n’ebiwandiiko eby’oluvannyuma lw’okutunda (MDD yeetaaga ebiwandiiko eby’ekikugu eby’ebintu byokka);
d) Lipoota y’okwekenneenya obujjanjabi.MDR yeetaaga amakampuni okuwaayo enkyusa ey’okuna eya lipoota ez’okwekenneenya obujjanjabi, nga zino nkalu okusinga enkyusa ey’okusatu;
3) Okugaziya obuwanvu bw’okukozesa
a) MDD etunuulira ebintu byokka ebirina ebigendererwa by’obujjanjabi, ate MDR erimu ebyuma ebimu ebitali bya bujjanjabi mu buwanvu bw’okukozesa, gamba nga lenzi z’enva endiirwa, ebintu eby’okwewunda, n’ebirala;
b) Mu MDD, ebyuma ebiddamu okukozesebwa biba mu kibinja ky’ebyuma eby’obujjanjabi era tebyetaagisa kuyingira mu nsonga za kitongole ekitegeezeddwa, ate MDR yeetaaga ekitongole ekitegeezeddwa okukola okwekenneenya okukwatagana kw’ebyuma ebilongoosa ebiddamu okukozesebwa;
4) MDR yeetaaga obwerufu n’okulondoola okusingawo
a) Yaleeta ekintu eky’enjawulo ekimanyisa ekyuma ekya UDI okwongera ku kulondoola ebintu;
b) Amawulire agakwatagana agakwata ku kkampuni gajja kukuŋŋaanyizibwa mu European Medical Device Database (EUDAMED);
c) Okuteekawo enkola y’okulondoola oluvannyuma lw’akatale (PMS);
d) Ekitongole ekitegeezeddwa kijja kukola okukebera okutalangiriddwa.
Kiki okwekenneenya kw’obujjanjabi ku MDR CE?
Enkola y’obujjanjabi gye twogerako okutwalira awamu egabanyizibwamu engeri bbiri:
a) Okugezesebwa mu malwaliro kukozesebwa ku bantu okufuna data okukakasa obukuumi bw’ekintu ekyo.
b) Lipoota z’obujjanjabi okusinga zikakasa obukuumi n’obulungi bw’ekintu nga ziyita mu kugeraageranya ebintu (okuva mu nsonga ssatu: ebikwata ku bujjanjabi, ebipimo by’eby’ekikugu, n’enkola y’ebiramu), okwekenneenya ebikwata ku bikozesebwa, n’okwekenneenya ebiwandiiko.
c) Lipoota y’okwekenneenya obujjanjabi kitundu ku kiwandiiko kya CE eky’ekikugu era era kitundu kikulu (lipoota y’okwekenneenya obujjanjabi lipoota eyeetaagibwa mu kiwandiiko ky’eby’ekikugu ekya CE ng’osaba satifikeeti ya CE).
d) Mu kiseera kino, enkyusa ey’okuna eya lipoota y’okwekenneenya obujjanjabi eteekebwa mu nkola, nga eno ye lipoota y’okwekenneenya obujjanjabi ekuŋŋaanyiziddwa okusinziira ku ndagiriro y’okwekenneenya obujjanjabi MedDev 2.7.1.
Okuyita mu satifikeeti ya MDR kitegeeza nti Joytech omulondozi wa puleesa era ... digital thermometer zituuse ku mutindo omukakali mu dizayini, okufulumya n’okulondoola omutindo, era zisobola okuwa ebyuma eby’obujjanjabi ebisingako obukuumi era ebyesigika eri abakozesa okwetoloola ensi yonna.
Joytech blood pressure monitor ne digital thermometer biwangudde okusiimibwa awatali kuwakanya okuva mu bakozesa olw’ebivudde mu kupima okutuufu, dizayini ennyangu okukozesa n’okukola obulungi.Kati, bayise mu satifikeeti ya MDR, awatali kubuusabuusa egenda kwongera okutumbula obwesige n’okumatizibwa kw’abakozesa mu bintu byaffe.
Joytech Healthcare egenda kusigala nga yeewaddeyo okugaba... ebyuma eby’obujjanjabi eby’omutindo ogwa waggulu n’okuyamba ku bulamu bw’ababikozesa okwetoloola ensi yonna.Tukkiriza nti okuyita mu kaweefube waffe, ebintu byaffe eby’omutindo bijja kuyamba mu bulamu bwo obulungi ku katale k’ensi yonna.
Bw’oba olina ekibuuzo kyonna oba ky’oyagala ku bintu byaffe ebipima puleesa n’ebipima ebbugumu, tukusaba otutuukirire.
