A wannan makon mun gudanar da horo kan dokokin MDR.Hitec Medical yana neman takardar shaidar MDR CE da ƙiyasin samunta a watan Mayu mai zuwa.

Mun koyi game da tsarin ci gaba na ka'idojin MDR.

A ranar 5 ga Mayu, 2017, Jarida ta Ƙungiyar Tarayyar Turai ta fito da Dokar Na'urar Lafiya ta EU (MDR) 2017/745 a hukumance.

Manufar wannan ƙa'idar ita ce tabbatar da ingantaccen kariya ga lafiyar jama'a da amincin marasa lafiya.MDR za ta maye gurbin Dokokin 90/385/EEC (Uwararrun Na'urar Na'urar Kiwon Lafiya Mai Aiki) da 93/42/EEC (Umarnin Na'urar Likita).Dangane da bukatun MDR Mataki na 123, MDR ta fara aiki a hukumance a ranar 26 ga Mayu, 2017 kuma ta maye gurbin MDD (93/42/EEC) da AIMDD (90/385/EEC) a hukumance a ranar 26 ga Mayu, 2020.

Sakamakon tasirin COVID-19, sanarwar game da sake fasalin ranar MDR na sabuwar dokar EU MDR a ranar 23 ga Afrilu, 2020 a hukumance ta sanar da cewa an dage aiwatar da MDR zuwa 26 ga Mayu, 2021.

Fara daga Mayu 26, 2021, duk na'urorin kiwon lafiya da aka ƙaddamar da su a cikin Tarayyar Turai dole ne su bi ka'idodin MDR.

Bayan aiwatar da MDR, har yanzu yana yiwuwa a nemi takardar shedar CE bisa ga MDD da AIMDD a cikin shekaru uku na mika mulki da kuma kiyaye ingancin takaddun shaida.Dangane da sashi na 120 sakin layi na 2, takardar shaidar CE da NB ta bayar yayin lokacin mika mulki zai ci gaba da aiki, amma ba zai wuce shekaru 5 daga ranar isar da shi ba kuma zai ƙare a ranar 27 ga Mayu, 2024.

Amma, ci gaban MDR bai yi kyau kamar yadda ake tsammani ba, kuma manufar da ake yi yanzu ita ce kamar haka.

Kafin Mayu 26, 2024, kamfanoni dole ne su gabatar da aikace-aikacen MDR ga ƙungiyoyin da aka sanar, sannan za a iya tsawaita takaddun shaida na MDD (IIb, IIa, da na'urorin I) har zuwa Disamba 31, 2028.