Sabata ino tidachita maphunziro okhudza malamulo a MDR.Hitec Medical ikufunsira satifiketi ya MDR CE ndikuyerekeza kuti ipeza Meyi wamawa.

Tinaphunzira za ndondomeko ya chitukuko cha malamulo a MDR.

Pa Meyi 5, 2017, Official Journal of the European Union idatulutsa mwalamulo EU Medical Device Regulation (MDR) 2017/745.

Cholinga cha lamuloli ndikuwonetsetsa chitetezo chabwino chaumoyo wa anthu komanso chitetezo cha odwala.MDR idzalowa m’malo mwa Directives 90/385/EEC (Active Implantable Medical Device Directive) ndi 93/42/EEC (Medical Device Directive).Malinga ndi zofunikira za Article 123 ya MDR, MDR idayamba kugwira ntchito pa Meyi 26, 2017 ndipo idalowa m'malo mwa MDD (93/42/EEC) ndi AIMDD (90/385/EEC) pa Meyi 26, 2020.

Chifukwa chakukhudzidwa kwa COVID-19, chidziwitso pakukonzanso kwa tsiku la MDR la malamulo atsopano a EU MDR pa Epulo 23, 2020 adalengeza kuti kukhazikitsidwa kwa MDR kuyimitsidwa mpaka Meyi 26, 2021.

Kuyambira pa Meyi 26, 2021, zida zonse zamankhwala zomwe zangotulutsidwa kumene ku European Union ziyenera kutsatira zomwe MDR ikufuna.

Pambuyo pa kukhazikitsidwa kwa MDR, ndizothekabe kulembetsa ziphaso za CE molingana ndi MDD ndi AIMDD munthawi yakusintha kwazaka zitatu ndikusunga ziphaso zovomerezeka.Malinga ndi Ndime 120 clause2, satifiketi ya CE yoperekedwa ndi NB panthawi yakusintha ikhalabe yovomerezeka, koma sichitha zaka 5 kuchokera pa tsiku loperekedwa ndipo idzatha pa Meyi 27, 2024.

Koma, kupita patsogolo kwa MDR sikunayende bwino monga momwe amayembekezerera, ndipo ndondomeko yamakono ili motere,

Asanafike Meyi 26, 2024, mabizinesi ayenera kutumiza fomu yofunsira MDR ku mabungwe awo odziwitsidwa, ndiye kuti satifiketi zawo za MDD (IIb, IIa, ndi I zida) zitha kuwonjezedwa mpaka Disembala 31, 2028.