Ku ya 28 . Mata 2022, Joytech yabonye itangwa rya mbere rya EU MDR kubakozi bacu badashobora gutera, urashobora kumenya ibisobanuro hano.
Muri 2023, Joytech hamagara thermometero, ntabwo yahuye na thermometero hamwe numuvuduko ukabije wamaraso ni eu MDR yemejwe.
CE (MDR) ni iki?
Iyo bigeze kuri CE Impamyabumenyi, abantu bose baramenyereye. Hafi ya byose inganda zifite icyemezo cya CE. MDR ni amagambo ahinnye y'ibikoresho by'ubuvuzi by'Uburayi, aribwo amakuru agezweho ya CE (MDD) akanashyikiriza umutekano n'imikorere y'ibikoresho by'ubuvuzi. Turabita kandi CE (MDR).
Ni irihe tandukaniro riri hagati ya CE (MDD) na CE (MDR)?
MDR ni amabwiriza na mdd ni amabwiriza. Kubera ko ari izamu, kuva mu mabwiriza ku mabwiriza, ibihugu bigize Umuryango w'ubutaka bizakoresha imbaraga zikaze ku buryo bwo gutanga ibyemezo n'ibisubizo.
Ahanini bigaragarira mu ngingo zikurikira:
1) Yashimangiye inshingano zabakorera.
a) uwabikoze agomba kuba afite byibuze umuyobozi umwe wubahiriza ubuhanga hamwe nubuhanga mubikorwa byubuvuzi (nta gisabwa mu kuyobora Madd);
b) Uwayikoze agomba gushinga kandi akomeza kuvugurura inyandiko za tekiniki no kwemeza ko iboneka iyo isabwe nubuyobozi bubifitiye ububasha.
c) Abakora bagomba kwitabira ubugenzuzi butamenyeshejwe ukoresheje imigi imenyeshwa umwanya uwariwo wose kugirango habeho amakuru ya tekiniki no gufata neza sisitemu; (Ibicuruzwa bya II
d) Kubicuruzwa byinshi bibangamira ibigo byubucuruzi, bizagora gusaba CC.
2) Kongera ingingo zishinzwe kugenzura no gusuzuma neza.
a) Kongera amategeko yo gukurikira: Kuva 18 i MDD kugeza 22 muri MDR;
b) Ibisabwa byibanze byo kugenzura biriyongera: kuva mubintu 13 muri MDD kugeza 23 muri MDR;
c) Imiterere yinyandiko za CE zahindutse kandi zigabanijwemo: Ibyangombwa bya tekiniki hamwe nibyangombwa nyuma yo kwamamaza (MDD gusa bisaba ibyangombwa bya tekiniki);
D) Raporo y'Isuzuma rya Clinical. MDR isaba ibigo kugirango itange verisiyo ya kane ya raporo zisuzuma ryavunjijwe, kikaba kirenze verisiyo ya gatatu;
3) Umwanya wagutse
a) mdd intego gusa nibikorwa byubuvuzi, mugihe MDR irimo ibikoresho bimwe na bimwe bitari mu buvuzi muburyo bwo gusaba, nk'ibihugu by'imboga, ibicuruzwa byubwiza, nibindi .;
b) Mu bikoresho bya MDD, ibikoresho bikoreshwa bishyirwa mu cyiciro cyibikoresho byubuvuzi kandi ntibisaba gutabara umubiri ubimenyeshejwe, mugihe MDR isaba urwego rwujuje ibisabwa kugirango abone isuzuma rifatika ryibikoresho byo kubaga byo kubaga;
4) MDR isaba gukorera mu mucyo kandi irambuye
a) Yatangiriye ikikoresho cyihariye cya UDI kongera uburyo bwo kongera ibicuruzwa;
b) amakuru ajyanye na sosiyete azakusanywa mububiko bwibikoresho byubuvuzi bwu Burayi (Eudamed);
c) gushyiraho sisitemu yo kugenzura ibicuruzwa (PMS);
d) Umubiri ubimenyeshejwe uzakora igenzura ridasubirwaho.
Isuzuma ry'amavuriro rya MDR IC ni irihe?
Imyitozo ya clinique tuvuga muri rusange igabanijwemo uburyo bubiri:
a) Ibigeragezo byubuvuzi bikoreshwa kubantu kugirango babone amakuru kugirango yerekane umutekano wibicuruzwa.
b) Raporo yubuvuzi yerekanaga cyane umutekano nuburyo bukora ibicuruzwa binyuze mubicuruzwa biranga ibicuruzwa (uhereye kubintu bitatu: amakuru ya tekiniki, hamwe nibinyabuzima), gusesengura amakuru, nibisobanuro byivanga.
c) Raporo y'isuzuma rya Clinical ni imwe mu nyandiko ya CE na kandi ni ikintu cy'ingenzi (Raporo y'isuzuma ryakozwe mu nyandiko itangwa na CE inyandiko ya CE iyo isaba CE Icyemezo cya Tekinike).
d) Kugeza ubu, inyandiko ya kane ya raporo y'isuzuma ry'ivunjizwa ishyirwa mu bikorwa, raporo y'isuzuma ry'ubuvuzi yakozwe hakurikijwe umurongo ngenderwaho wo gusuzuma Meddev 2.7.1.
Gutambuka Icyemezo cya MDR bivuze ko MomerTech Road Monitor Monitor na TranOmetero ya Digital yageze ku bipimo bikomeye mu gishushanyo, umusaruro n'ubuyobozi bwiza, kandi irashobora gutanga ibikoresho by'ubuvuzi byiza kandi byizewe ku bakoresha ku isi.
JUEVDECHROL MOBIL MOBIL NA THEMOMETER THEMMOMETER yatsindiye ishimwe n'abakoresha ibipimo byabo byiza, igishushanyo mbonera cyumukoresha nigikorwa cyiza. Noneho, batsinze ibyemezo bya MDR, bidasubirwaho bizakomeza kuzamura abakoresha no kunyurwa mubicuruzwa byacu.
Ubuvuzi bwa Joytech buzakomeza kwiyemeza gutanga Ibikoresho byiza byubuvuzi no gutanga umusanzu mubuzima bwabakoresha kwisi. Twizera ko binyuze mu mbaraga zacu, ibicuruzwa byacu bifite ireme bizafasha ubuzima bwawe bwiza ku isoko ryisi.
Niba ufite ikibazo cyangwa ukeneye kubibazo byumuvuduko wamaraso hamwe nibicuruzwa bya arnometero, nyamuneka twandikire.
