Kuva ku ya 1 Mutarama 2022, ibikoresho byose by’ubuvuzi byinjira mu bihugu by’ubukungu bw’ubumwe bw’ibihugu by’Uburayi nk’Uburusiya, Biyelorusiya, Kazakisitani, Arumeniya, Kirigizisitani, n’ibindi bigomba kwandikwa hakurikijwe amabwiriza y’ubumwe bw’ibihugu by’Ubumwe bw’Ubumwe bw’Uburayi.Noneho wemere gusaba icyemezo cyo kwandikisha ibikoresho byubuvuzi mugihugu kimwe.Ibikoresho byubuvuzi byanditswe muri Federasiyo y’Uburusiya birashobora gukomeza gukoreshwa, cyangwa icyemezo cyanditswe gishobora guhinduka kugeza mu 2027.
EAC MDR Itondekanya ibicuruzwa
Ukurikije urwego rutandukanye rw’ibyago, EAC MDR irashobora kugabanywa mu cyiciro cya I, Icyiciro cya IIa, Icyiciro cya IIb, Icyiciro cya III, icyiciro cya III gifite urwego rw’ibyago byinshi, bisa n’umuryango w’ubumwe bw’ibihugu by’Uburayi.Urwego rwibyago byinshi, nuburyo bwo kwiyandikisha nibisabwa.
EAC MDR Gahunda yo Kwemeza
1. Kumenya urwego rwibyago nubwoko bwizina ryakoreshwa 2. Kugena urutonde rwinyandiko 3. Gukusanya ibimenyetso byumutekano nibikorwa neza 4. Guhitamo aho uhagaze no kumenyekana
5. Kwishura amahoro ya gasutamo
6. Tanga inyandiko
7. Kugenzura umusaruro wibikoresho byubuvuzi, nibindi.
8. Uburyo bwo Kwemeza
9. Kwandikisha ibikoresho byubuvuzi
EAC MDR Amakuru Yimpamyabumenyi
Urutonde rwamakuru rukurikira ntiruhitamo, bitewe nurwego rwibyago byibicuruzwa kugirango hemezwe niba bigomba gutangwa.
1. Saba muburyo bwerekanwe kumugereka
2 na 3 za “Kwiyandikisha n’amategeko y’umwuga agenga umutekano, ubuziranenge n’ubushobozi bw’ibikoresho by’ubuvuzi”
3. Ibaruwa yemewe yerekana inyungu zuwabikoze mugihe wiyandikishije
4. Kopi yicyemezo cya sisitemu yubuyobozi bufite ireme (ISO 13485 cyangwa ibipimo ngenderwaho bijyanye nakarere cyangwa igihugu cyibihugu bigize uyu muryango)
5. Umutekano wibikoresho byubuvuzi nibimenyekanisha bihuye cyangwa inyandiko ihwanye
6. Icyemezo cyo kwiyandikisha gitangwa nigihugu cyakorewe (Kopi yicyemezo cyo kugurisha kubuntu, icyemezo cyo kohereza hanze (usibye ibikoresho byubuvuzi byakorewe bwa mbere mubutaka bwibihugu bigize Umuryango)) kandi bihindurwa muburusiya
7. Kopi yinyandiko zemeza kwiyandikisha mubindi bihugu
8. Icyemezo cyibikoresho byubuvuzi byerekana igikoresho cyubuvuzi Scope, ikoreshwa, ibiranga bigufi, verisiyo nibikoresho (form)
9. Kumenyekanisha no gupakira amakuru (imiterere yuzuye y'amabara yo gupakira hamwe na labels, inyandiko yanditse mu kirusiya no mu ndimi zemewe z'ibihugu bigize uyu muryango)
10. Iterambere nogukora amakuru: gushushanya inzira yo gushushanya, Intambwe zingenzi zo gukora, gupakira, kugerageza nuburyo bwo gusohora ibicuruzwa byanyuma
11. Amakuru ajyanye nuwabikoze: izina, ubwoko bwibikorwa, aderesi yemewe, uburyo bwa nyirubwite, imiterere yubuyobozi, urutonde rwamashami nabafashanyabikorwa, no gusobanura uko bahagaze nububasha bwabo
12. Ibyabaye no Kwibuka Raporo (ntabwo itanga amakuru kubikoresho byubuvuzi bishya byateguwe kandi byateguwe): urutonde rwibintu bibi cyangwa ibintu bifitanye isano no gukoresha igikoresho, no kwerekana igihe ibyo bintu byabereye, niba bihari ni ibintu byinshi bibi cyane, birashobora kuba nkenerwa muburyo bwibyabaye Tanga incamake muri make kandi werekane umubare rusange wibyabaye byatangajwe kuri buri bwoko Urutonde rwibitekerezo na / cyangwa amatangazo asobanura ku isoko ryibikoresho byubuvuzi no gusobanura ibyabaye, uburyo bwo kubikemura hamwe nuwabikoze muri buri kibazo Igisubizo gisobanura isesengura na / cyangwa ibikorwa byo gukosora bigomba gukorwa mugusubiza ibi bibazo 13. Urutonde rwibipimo ibikoresho byubuvuzi bihura (hamwe namakuru ajyanye)
14. Ibisabwa muri rusange, ibirango bisabwa hamwe namakuru asabwa ninyandiko zikorwa (aha ni ukuvuga - ibisabwa muri rusange)
15. Inyandiko zerekana ibisabwa kubiranga tekiniki yibikoresho byubuvuzi 16. Raporo y ibizamini bya tekiniki byakozwe kugirango yerekane kubahiriza ibisabwa muri rusange
17. Porotokole yubushakashatsi (ibizamini) gusuzuma ingaruka zibinyabuzima byibikoresho byubuvuzi, Intego zo kwerekana ko zujuje ibisabwa muri rusange
18. Ibimenyetso byubuvuzi bitanga raporo ku mikorere n’umutekano wibikoresho byubuvuzi
19. Raporo yo gusesengura ingaruka
20. Amakuru yibiyobyabwenge mubikoresho byubuvuzi (ibiyigize, ingano, ibiyobyabwenge nibikoresho byubuvuzi bihuza, Kwandikisha ibicuruzwa byibiyobyabwenge mugihugu cyakorewe)
21. Amakuru yumutekano
22. Uburyo bwo kuboneza urubyaro, harimo kwemeza inzira, ibisubizo byikizamini cya mikorobe (urwego rwa bioburden), pyrogenicity, sterility (nibiba ngombwa), hamwe nuburyo bwikizamini cyamabwiriza hamwe nugupakira Amakuru kumibare yemewe (ibicuruzwa bitemewe)
23. Amakuru yihariye ya software (niba ahari): Amakuru yuwakoze kubyerekeye kwemeza software
24. Raporo yubushakashatsi butajegajega - hamwe nubusobanuro bwikirusiya bwukuri bwibisubizo byikizamini hamwe nu myanzuro kubicuruzwa bifite ubuzima bubi
25. Koresha mubihugu byemewe Gukoresha inyandiko cyangwa amabwiriza yo gukoresha ibikoresho byubuvuzi mururimi rwigihugu (nibiba ngombwa) no muburusiya
26. Imfashanyigisho za serivisi (mugihe cyibigize ibikoresho byubuvuzi) - mugihe habuze amakuru mubyangombwa bikora
27. Raporo yubugenzuzi bwumusaruro 28. Gahunda yo gukusanya no gusesengura amakuru yumutekano ningirakamaro byibikoresho byubuvuzi mugice cyanyuma cyo kwamamaza