nga 28 th . April 2022, Joytech yafuna okusooka okufulumya EU MDR ku ba monitors baffe abatali bayingira mu musaayi,Osobola okuzuula ebisingawo wano.
Mu mwaka gwa 2023, JoyTech contact thermometers, non contact thermometers ne pressure monitors empya zonna zikkirizibwa EU MDR.
CE CE (MDR) kye ki?
Bwe kituuka ku satifikeeti za CE, buli muntu aba amanyidde ddala. Kumpi buli mulimu gulina satifikeeti ya CE ekwatagana. MDR ye nfunyiro y’okulungamya ebyuma bya Bulaaya eby’obujjanjabi, nga eno ye nnongoosereza ya CE (MDD) era essaawo ebisaanyizo eby’amaanyi ku bulamu n’enkola y’ebyuma eby’obujjanjabi. Era tukiyita ce (mdr).
Njawulo ki eri wakati wa CE (MDD) ne CE (MDR)?
MDR ye regulation ate MDD kiragiro. Olw’okuba nti kulongoosa, okuva ku biragiro okutuuka ku biragiro, amawanga agali mu mukago gwa EU gajja kufuga nnyo enkola y’okuweebwa satifikeeti n’ebivaamu.
Okusinga okweyolekera mu bintu bino wammanga:
1) Yanyweza obuvunaanyizibwa bw’omukozi.
a) Omukozi alina okuba n’omukungu w’okugoberera waakiri omu n’obukugu mu mulimu gw’ebyuma eby’obujjanjabi (tewali kyetaagisa mu bulambulukufu mu kiragiro kya MDD);
b) Omukozi alina okuteekawo n’okutereeza ebiwandiiko eby’ekikugu n’okukakasa nti bibaawo nga bisabiddwa ekitongole ekivunaanyizibwa mu ggwanga.
c) Abakola ebintu balina okwanukula okwekebejja okutategeerekese okuva mu bitongole ebimanyiddwa ekiseera kyonna okukakasa nti enkola ey’ekikugu erongooseddwa n’okulabirira enkola eno; (Ebikolebwa mu Kibiina II) .
d) Ku bintu eby’omutawaana ennyo ebya kkampuni z’okusuubula, kijja kuba kizibu nnyo okusaba CE.
2) Okwongera ku nteekateeka z’okulungamya n’okuddamu okwetegereza okukakasa okukakali.
a) Amateeka g’okugabanya ag’okwongera: okuva ku 18 mu MDD okutuuka ku 22 mu MDR;
b) Ebintu ebikulu eby’okukebera ebyetaago byongerwako: okuva ku bintu 13 mu MDD okutuuka ku 23 mu MDR;
c) Ensengeka y’ebiwandiiko by’ebyekikugu bya CE ekyuse era egabanyizibwamu: ebiwandiiko by’eby’ekikugu eby’ebintu n’ebiwandiiko eby’oluvannyuma lw’okutunda (MDD yeetaaga ebiwandiiko eby’ekikugu eby’ebintu byokka);
d) Alipoota y’okwekenneenya obujjanjabi. MDR esaba amakampuni okuwa lipoota ey’okuna ey’okukebera obujjanjabi, nga kino kisinga kukakatako okusinga eky’okusatu;
3) Obunene bw’okukozesa obugaziyiziddwa .
a) MDD etunuulira ebintu byokka ebirina obujjanjabi, ate MDR erimu ebyuma ebimu ebitali bya bujjanjabi mu buwanvu bw’okukozesa, gamba nga lenzi z’enva endiirwa, eby’okwewunda n’ebirala;
b) Mu MDD, ebyuma ebiddamu okukozesebwa biteekebwa mu kibinja ky’ebyuma eby’obujjanjabi era tebyetaagisa kuyingirira kitongole ekimanyiddwa, ate nga MDR yeetaaga ekitongole ekimanyiddwa okukola okwekenneenya okukwatagana kw’ebyuma ebirongoosa ebiddamu okukozesebwa;
4) MDR yeetaaga obwerufu obusingawo n’okulondoola .
a) yayanjula ekintu eky’enjawulo ekimanyisa UDI okwongera okulondoola ebintu;
b) Amawulire agakwatagana aga kkampuni gajja kukuŋŋaanyizibwa mu kifo ekikuumirwamu ebyuma eby’obujjanjabi mu Bulaaya (Eudamed);
c) Okuteekawo enkola y’okulondoola (PMS) oluvannyuma lw’akatale;
d) Ekitongole ekimanyiddwa kijja kukola okwekebejja okutategeezeddwa.
Okukebera MDR E.E.
Enkola y’obujjanjabi gye twogera okutwalira awamu egabanyizibwamu engeri bbiri:
a) Okugezesebwa mu malwaliro kukozesebwa ku bantu okufuna amawulire okukakasa obukuumi bw’ekintu.
b) Lipoota z’obujjanjabi okusinga zikakasa obukuumi n’obulungi bw’ekintu okuyita mu kugeraageranya ekintu (okuva mu nsonga ssatu: ebikwata ku bujjanjabi, ebipimo by’eby’ekikugu, n’enkola y’ebiramu), okwekenneenya amawulire, n’okuddamu okwetegereza ebiwandiiko.
c) Alipoota y’okwekenneenya obujjanjabi kitundu kya kiwandiiko kya tekinologiya wa CE era era kitundu kikulu (lipoota y’okwekenneenya obujjanjabi ye lipoota eyetaagisa ennyo mu kiwandiiko ky’ebyekikugu ekya CE ng’osaba okuweebwa satifikeeti ya CE).
d) Mu kiseera kino, enkyusa ey’okuna eya lipoota y’okwekenneenya obujjanjabi essiddwa mu nkola, nga eno lipoota y’okwekenneenya obujjanjabi ekuŋŋaanyiziddwa okusinziira ku ndagiriro y’okukebera obujjanjabi Meddev 2.7.1.
Okuyisa satifikeeti ya MDR kitegeeza nti . joytech okulondoola puleesa n’ Digital thermometer etuuse ku mutindo omukakali mu dizayini, okufulumya n’okulondoola omutindo, era esobola okuwa ebyuma eby’obujjanjabi ebisinga obukuumi era ebyesigika eri abakozesa okwetoloola ensi yonna.
Joytech blood pressure monitor ne digital thermometer ziwangudde okutenderezebwa kwonna okuva mu bakozesa olw’ebivudde mu kupima kwabwe okutuufu, dizayini enyangu okukozesa n’okukola obulungi. Kati, bayise mu satifikeeti ya MDR, awatali kubuusabuusa ejja kwongera okutumbula obwesige bw’abakozesa n’okumatizibwa mu bintu byaffe.
Joytech Healthcare ejja kusigala nga yeewaddeyo okugaba . Ebyuma eby’obujjanjabi eby’omutindo ogwa waggulu n’okuyamba ku bulamu bw’abakozesa okwetoloola ensi yonna. Tukkiriza nti okuyita mu kaweefube waffe, ebintu byaffe eby’omutindo bijja kuyamba obulamu bwo obulungi mu katale k’ensi yonna.
Bw’oba olina ekibuuzo kyonna oba kye weetaaga ku kulondoola puleesa yaffe n’ebintu ebipima ebbugumu, nsaba otutuukirire.
