Muri iki cyumweru twakoze amahugurwa ku mabwiriza ya MDR.Ubuvuzi bwa Hitec busaba icyemezo cya MDR CE kandi ugereranya kubibona muri Gicurasi umwaka utaha.

Twize kubyerekeye iterambere ryamabwiriza ya MDR.

Ku ya 5 Gicurasi 2017, Ikinyamakuru cyemewe cy’Umuryango w’ubumwe bw’ibihugu by’Uburayi cyasohoye ku mugaragaro amabwiriza y’ibikoresho by’ubuvuzi by’Uburayi (MDR) 2017/745.

Intego y'aya mabwiriza ni ukurinda kurushaho kurengera ubuzima rusange n'umutekano w'abarwayi.MDR izasimbuza Amabwiriza 90/385 / EEC (Amabwiriza agenga ibikoresho by’ubuvuzi bifatika) na 93/42 / EEC (Amabwiriza y’ubuvuzi).Dukurikije ibisabwa MDR Ingingo ya 123, MDR yatangiye gukurikizwa ku mugaragaro ku ya 26 Gicurasi 2017, isimbuza ku mugaragaro MDD (93/42 / EEC) na AIMDD (90/385 / EEC) ku ya 26 Gicurasi 2020.

Kubera ingaruka za COVID-19, itangazo ryerekeye ivugurura ry’itariki ya MDR y’amabwiriza mashya y’ubumwe bw’ibihugu by’Uburayi MDR ku ya 23 Mata 2020 ryatangaje ku mugaragaro ko ishyirwa mu bikorwa rya MDR ryimuriwe ku ya 26 Gicurasi 2021.

Guhera ku ya 26 Gicurasi 2021, ibikoresho byose byubuvuzi bishya byatangijwe mu muryango w’ubumwe bw’ibihugu by’Uburayi bigomba kubahiriza ibisabwa na MDR.

Nyuma yo gushyira mu bikorwa MDR, biracyashoboka gusaba ibyemezo bya CE ukurikije MDD na AIMDD mugihe cyimyaka itatu yinzibacyuho no gukomeza kwemeza ibyemezo.Dukurikije ingingo ya 120 ingingo ya 2, icyemezo cya CE cyatanzwe na NB mugihe cyinzibacyuho kizakomeza kugira agaciro, ariko ntigishobora kurenza imyaka 5 uhereye igihe cyatangiriye kandi kizarangira ku ya 27 Gicurasi 2024.

Ariko, iterambere rya MDR ntabwo ryagenze neza nkuko byari byitezwe, kandi politiki iriho niyi ikurikira,

Mbere y'itariki ya 26 Gicurasi 2024, ibigo bigomba gutanga MDR mu nzego zamenyeshejwe, hanyuma ibyemezo bya MDD (IIb, IIa, na I ibikoresho) birashobora kongerwa kugeza ku ya 31 Ukuboza 2028.