Ku 28 ya .Mata 2022, Joytech yabonye itangwa rya mbere rya EU MDR kubashinzwe gukurikirana umuvuduko wamaraso inv ushobora kumenya amakuru arambuye hano.
Muri 2023, Joytech hamagara ibipimo bya termometero, kutabonana na termometero hamwe na monitor nshya yumuvuduko wamaraso byose byemewe na MDR ya EU.
CE （MDR ni iki?
Iyo bigeze kuri CE ibyemezo, abantu bose barabimenyereye.Hafi yinganda zose zifite icyemezo cya CE.MDR ni impfunyapfunyo y’amabwiriza y’ibikoresho by’ubuvuzi by’i Burayi, aribyo kuvugurura CE (MDD) kandi ishyiraho ibisabwa byinshi ku mutekano n’imikorere y’ibikoresho by’ubuvuzi.Tuyita kandi CE （MDR）.
Ni irihe tandukaniro riri hagati ya CE （MDD） na CE （MDR）?
MDR ni amabwiriza kandi MDD nubuyobozi.Kubera ko ari ukuzamura, kuva ku mabwiriza kugera ku mabwiriza, ibihugu bigize Umuryango w’ubumwe bw’ibihugu by’Uburayi bizagenzura cyane inzira yo gutanga ibyemezo n'ibisubizo.
Ahanini bigaragarira mubice bikurikira:
1) Gushimangira inshingano zuwabikoze.
a) Uwayikoze agomba kuba afite byibura umuyobozi umwe wujuje ibyangombwa mubijyanye nubuvuzi (nta bisabwa bigaragara mubuyobozi bwa MDD);
b) Uruganda rugomba gushiraho no guhora ruvugurura ibyangombwa bya tekiniki kandi rukareba ko ruboneka iyo bisabwe ninzego zigihugu zibifitiye ububasha.
c) Ababikora bagomba gusubiza ubugenzuzi butamenyeshejwe ninzego zamenyeshejwe igihe icyo aricyo cyose kugirango harebwe ivugururwa ryibyangombwa bya tekiniki no kubungabunga sisitemu;(Ibicuruzwa byo mu cyiciro cya II)
d) Kubicuruzwa bifite ibyago byinshi byamasosiyete yubucuruzi, bizagorana cyane gusaba CE.
2) Kongera ingingo zigenga no gusuzuma ibyemezo bikaze.
a) Kongera amategeko yo gutondekanya: kuva 18 muri MDD kugeza 22 muri MDR;
b) Ibyingenzi byibanze bisabwa kurutonde rwiyongereye: kuva mubintu 13 muri MDD kugeza 23 muri MDR;
c) Imiterere yinyandiko za tekinike ya CE yarahindutse kandi igabanijwemo: inyandiko tekinike yibicuruzwa ninyandiko zamamaza nyuma (MDD isaba gusa ibyangombwa bya tekiniki yibicuruzwa);
d) Raporo yo gusuzuma ivuriro.MDR isaba ibigo gutanga verisiyo ya kane ya raporo yo gusuzuma ivuriro, ikaba ikomeye kuruta verisiyo ya gatatu;
3) Kwagura ibikorwa
a) MDD yibanda gusa kubicuruzwa bifite intego zubuvuzi, mugihe MDR ikubiyemo ibikoresho bimwe na bimwe bitari ubuvuzi murwego rwo kubishyira mu bikorwa, nk'ibiti byo guhuza imboga, ibicuruzwa byiza, n'ibindi.;
b) Muri MDD, ibikoresho bikoreshwa byongeye gushyirwa mubyiciro byibikoresho byubuvuzi kandi ntibisaba ko hajyaho urwego rwabimenyeshejwe, mugihe MDR isaba urwego rumenyeshejwe gukora isuzuma rihuye n’ibikoresho byo kubaga byongera gukoreshwa;
4) MDR isaba gukorera mu mucyo no gukurikiranwa
a) Yerekanye ibikoresho byihariye biranga UDI kugirango yongere ibicuruzwa;
b) Amakuru ajyanye nisosiyete azakusanyirizwa mububiko bwibikoresho byubuvuzi byu Burayi (EUDAMED);
c) Gushiraho sisitemu yo kugenzura nyuma yisoko (PMS);
d) Urwego rubimenyeshejwe ruzakora ubugenzuzi butamenyeshejwe.
Ni irihe suzuma rya MDR CE?
Imyitozo ngororamubiri tuvuga muri rusange igabanijwemo uburyo bubiri:
a) Ibigeragezo bivura bikoreshwa kubantu kugirango babone amakuru yerekana umutekano wibicuruzwa.
b) Raporo y’amavuriro yerekana cyane cyane umutekano n’ingirakamaro ku bicuruzwa binyuze mu kugereranya ibicuruzwa (uhereye ku bintu bitatu: amakuru y’ubuvuzi, ibipimo bya tekiniki, n’imikorere y’ibinyabuzima), gusesengura amakuru, no gusuzuma ibitabo.
c) Raporo yisuzuma ryamavuriro iri mubice byubuhanga bwa CE kandi nayo ni igice cyingenzi (raporo yisuzuma ryamavuriro ni raporo yingirakamaro mu nyandiko ya tekinike ya CE mugihe usaba icyemezo cya CE).
d) Kugeza ubu, verisiyo ya kane ya raporo y’isuzuma ry’amavuriro yashyizwe mu bikorwa, ikaba ari raporo y’isuzuma ry’amavuriro yakozwe hakurikijwe umurongo ngenderwaho w’isuzuma ry’amavuriro MedDev 2.7.1.
Gutsindira icyemezo cya MDR bivuze ko Joytech umuvuduko wamaraso ukurikirana kandi ibipimo bya termometero bigeze ku bipimo bikaze mubishushanyo mbonera, kubyara no kugenzura ubuziranenge, kandi birashobora gutanga ibikoresho byubuvuzi byizewe kandi byizewe kubakoresha ku isi.
Igenzura ryumuvuduko wamaraso wa Joytech hamwe na sisitemu ya termometero yatsindiye ishimwe kubakoresha kubisubizo nyabyo byo gupima, igishushanyo mbonera cyabakoresha nibikorwa byiza.Noneho, batsinze icyemezo cya MDR, nta gushidikanya ko bizarushaho kongera icyizere cyabakoresha no kunyurwa kubicuruzwa byacu.
Ubuvuzi bwa Joytech buzakomeza kwiyemeza gutanga ibikoresho byubuvuzi bufite ireme kandi bigira uruhare mubuzima bwabakoresha kwisi yose.Twizera ko kubwimbaraga zacu, ibicuruzwa byacu byiza bizafasha mubuzima bwawe bwiza kumasoko yisi.
Niba ufite ikibazo cyangwa ukeneye kubijyanye na monitor yumuvuduko wamaraso hamwe nibicuruzwa bya termometero, nyamuneka twandikire.
