Umuryango w'ubumwe bw’ibihugu by’Uburayi ushyiraho amabwiriza yo kugenzura ibyago byinshi IVD, kugenzura ibikoresho byumurage

Byoherejwe 21 Gashyantare 2022 |Bya Nick Paul Taylor

Inyandiko ebyiri zubuyobozi zivuye mu itsinda ry’ibikorwa by’ubuvuzi bya komisiyo y’ibihugu by’i Burayi (MDCG) zigamije gutanga ibisobanuro birambuye ku bijyanye n’amabwiriza mashya ya medtech.

Icya mbere nubuyobozi bugenewe kumenyeshwa kugenzura ibikoresho bya virusi yo gusuzuma (IVD) murwego D, icyiciro kinini.Kwinjira muri Vitro Diagnostic Regulation (IVDR) ibika icyiciro D kugirango ibizamini bishobora guteza ibyago byinshi kubarwayi ndetse nubuzima rusange, nkibicuruzwa bigenzura imiti yanduza amaraso kugirango baterwe.Urebye ingaruka, IVDR itegeka uburyo bugoye bwo gusuzuma isuzuma ryicyiciro D IVD kirimo inzego zamenyeshejwe hamwe na laboratoire y’ubumwe bw’ibihugu by’Uburayi (EURL).

Nkuko ubuyobozi bubisobanura, imibiri yamenyeshejwe igomba kugenzura ibyiciro D IVDs.Kugenzura bizakenera imibiri yamenyeshejwe gukorana nabahinguzi na EURLs.

Ababikora bagomba gusangira raporo yibyiciro byabo D IVD hamwe numubiri wabimenyeshejwe kandi bagatanga ingero zo kwipimisha.Inzego zamenyeshejwe zishinzwe gutegura EURLs kugirango ikore ibizamini byicyitegererezo.Nyuma yo gukora igeragezwa ryicyiciro, EURL izasangiza ibyo yabonye hamwe numubiri wabimenyeshejwe.Kurangiza intambwe yo kugenzura bisukura uwabikoze kugurisha igikoresho, keretse iyo umubiri wabimenyeshejwe ugaragaza ikibazo mugihe cyiminsi 30 yakiriye icyitegererezo.

Ubuyobozi butanga kandi inama zuburyo inzego zamenyeshejwe zishobora kuzuza izo nshingano.Inzego zimenyeshejwe zikeneye inzira zanditse kugirango zigenzurwe, gahunda yikizamini ikubiyemo ibipimo byose byingenzi, hamwe namasezerano yakozwe na sample logistique.

MDGC iragira inama inzego zamenyeshejwe gushyiramo gahunda yikizamini, yemejwe na EURL, ikubiyemo amakuru nkurugero ruzageragezwa, inshuro zipimisha hamwe na platifomu y'ibizamini bizakoreshwa.Amasezerano agomba kandi gukemura ibibazo byukuntu ababikora bazabona ingero kubimenyesha cyangwa EURLs.Ababikora bagomba kwiyemeza kubwira imibiri yamenyeshejwe niba bohereje ingero kuri EURLs kandi niba bagize impinduka zishobora kugira ingaruka kubigenzura.

Ubuyobozi kandi bukemura amasezerano yanditse hagati yumuryango wabimenyeshejwe na EURL.Na none, MDGC iteganya ko urwego rwamenyeshejwe rushyira gahunda yikizamini mu masezerano.Amasezerano yihariye ya EURL akubiyemo gushyiramo amafaranga ya laboratoire hamwe nigihe ntarengwa cyo kugerageza no gutanga raporo.Igihe ntarengwa ni iminsi 30.

Kugenzura ibikoresho byumurage

Umunsi umwe nyuma yo gusohora ibyiciro D IVD, MDCG yasohoye ubuyobozi bujyanye no kugenzura ibikoresho byumurage byemewe kuguma ku isoko ry’ubumwe bw’ibihugu by’Uburayi kugeza muri Gicurasi 2024 hamwe n’impamyabumenyi zemewe zatanzwe mu gitabo cyitwa Active Implantable Medical Devices Directeur (AIMDD) cyangwa Ubuyobozi bw’ibikoresho by’ubuvuzi (MDD) .

Ubuyobozi bukemura ikibazo cyabajijwe nubuvuzi bwibikoresho byubuvuzi (MDR).Munsi ya MDR, ibikoresho byumurage birashobora kuguma kumasoko yuburayi kugeza 2024 niba byubahirije amabwiriza ashaje kandi ntibigire impinduka zikomeye.Icyakora, MDR irasaba kandi ibikoresho byumurage kugira ngo byuzuze ibisabwa n’amabwiriza ku kugenzura nyuma y’isoko, kugenzura isoko, kuba maso no kwandikisha abashoramari mu bukungu.Urebye ibyo, ni gute inzego zamenyeshejwe zikwiye kugenzura sisitemu yo gucunga neza ibikoresho byumurage?

Ubuyobozi bwa MDCG busubiza icyo kibazo, butegeka inzego zamenyeshejwe kuzirikana ibisabwa bishya mu rwego rwibikorwa byabo byo kugenzura.Mubikorwa, bivuze ko MDCG ishaka inzego zamenyeshejwe gusuzuma sisitemu yubuyobozi bufite ireme, kugenzura niba uwabikoze yagize ibyo ahindura bijyanye na MDR, hanyuma agakoresha ibyavuye mu isuzuma kugirango amenye gahunda y'ubugenzuzi.

Nkuko ibisabwa na MDR gusa bikoreshwa mubikoresho byumurage, "ibikorwa byubugenzuzi bizakorwa ninzego zamenyeshejwe bigomba gukomeza ibikorwa byabanje kugenzura hibandwa ku ngingo nshya."Ababikora bagomba gukora Raporo yigihe cyo kuvugurura umutekano hamwe na gahunda yo kugenzura amasoko ya raporo hamwe na raporo ziboneka kubigo byabo babimenyeshejwe kugirango bashobore "kugenzura ko sisitemu yo gucunga ubuziranenge yahinduwe neza kandi igakomeza kubahiriza icyemezo (s) cyatanzwe na MDD cyangwa AIMDD. ”

Ibisigaye mu buyobozi bisobanura ibintu byamenyeshejwe imibiri ishobora guhura bitewe n’aho ababikora bari muri gahunda ya MDR.Impanuro za MDCG muburyo bwo kwegera igenzura ziratandukanye bitewe n’urugero, uwabikoze agiye kuvana ibikoresho byayo ku isoko bitarenze 2024 cyangwa bimaze kwemezwa n’urundi rwego rubimenyeshejwe na MDR.