N'izu a, anyị mere ọzụzụ gbasara ụkpụrụ MDR.Hitec Medical na-etinye akwụkwọ maka asambodo MDR CE na atụmatụ iji nweta ya na Mee na-abịa.

Anyị mụtara banyere usoro mmepe nke iwu MDR.

Na Mee 5, 2017, akwụkwọ akụkọ Official nke European Union wepụtara iwu EU Medical Device Regulation (MDR) 2017/745.

Ebumnuche nke iwu a bụ iji hụ na nchekwa dị mma nke ahụike ọha na nchekwa ndị ọrịa.MDR ga-anọchi ntuziaka 90/385/EEC (Ntuziaka Ngwaọrụ Ahụike Na-arụ Ọrụ) yana 93/42/EEC (Ntuziaka Ngwaọrụ Ahụike).Dabere na ihe achọrọ nke MDR Nkeji edemede 123, MDR malitere ọrụ na Mee 26, 2017 wee dochie MDD (93/42/EEC) na AIMDD (90/385/EEC) na Mee 26, 2020.

N'ihi mmetụta nke COVID-19, ọkwa ahụ na ngbanwe nke ụbọchị MDR nke iwu EU ọhụrụ MDR na Eprel 23, 2020 kwupụtara n'ihu ọha na etinyere mmejuputa MDR na Mee 26, 2021.

Malite na Mee 26, 2021, ngwaọrụ ahụike niile ewepụtara ọhụrụ na European Union ga-agbasorịrị ihe MDR chọrọ.

Mgbe mmejuputa MDR gasịrị, ọ ka nwere ike itinye akwụkwọ maka asambodo CE dị ka MDD na AIMDD si dị n'oge mgbanwe afọ atọ ma nọgide na-enwe nkwado nke asambodo.Dị ka edemede 120 clause2 si kwuo, asambodo CE nke NB nyere n'oge oge mgbanwe ga-adị irè, mana ọ gaghị agafe afọ 5 site na ụbọchị nnyefe ya ga-agwụ na Mee 27, 2024.

Ma, ọganihu nke MDR adịghị mma dị ka a tụrụ anya ya, na amụma dị ugbu a bụ nke a,

Tupu Mee 26, 2024, ụlọ ọrụ ga-etinyerịrị ngwa maka MDR n'ahụ ndị ha mara ọkwa, mgbe ahụ enwere ike ịgbatị asambodo MDD ha (IIb, IIa na ngwaọrụ I) ruo Disemba 31, 2028.