Kule veki siqhube uqeqesho kwimigaqo ye-MDR.I-Hitec Medical yenza isicelo sesatifikethi se-MDR CE kwaye uqikelele ukusifumana ngoMeyi ozayo.

Sifunde malunga nenkqubo yophuhliso lwemigaqo ye-MDR.

Ngo-Meyi 5, i-2017, i-Official Journal ye-European Union ikhuphe ngokusemthethweni i-EU Medical Device Regulation (MDR) 2017/745.

Injongo yalo mmiselo kukuqinisekisa ukhuseleko olungcono lwempilo yoluntu kunye nokhuseleko lwezigulane.I-MDR iya kuthatha indawo ye-Directives 90/385/EEC (i-Active Implantable Medical Device Directive) kunye ne-93/42/EEC (i-Medical Device Directive).Ngokweemfuno ze-MDR Article 123, i-MDR yaqala ukusebenza ngokusemthethweni ngoMeyi 26, 2017 kwaye yatshintshwa ngokusemthethweni i-MDD (93/42/EEC) kunye ne-AIMDD (90/385/EEC) ngoMeyi 26, 2020.

Ngenxa yempembelelo ye-COVID-19, isaziso sohlaziyo lomhla we-MDR womgaqo omtsha we-EU i-MDR ngo-Epreli 23, 2020 ubhengeze ngokusesikweni ukuba ukuphunyezwa kwe-MDR kuhlehliselwe umhla wama-26 kuMeyi, 2021.

Ukususela ngoMeyi 26, 2021, zonke izixhobo zonyango ezisanda kuqaliswa kwi-European Union kufuneka zihambelane neemfuno ze-MDR.

Emva kokuphunyezwa kwe-MDR, kusenokwenzeka ukuba ufake isicelo sezatifikethi ze-CE ngokwe-MDD kunye ne-AIMDD ngexesha leminyaka emithathu yokutshintsha kunye nokugcina ukuqinisekiswa kwezatifikethi.NgokweSiqendu 120 igatya2, isatifikethi se-CE esikhutshwe yi-NB ngexesha lotshintsho siya kuhlala sisemthethweni, kodwa asiyi kudlula iminyaka emi-5 ukusuka kumhla wokuhanjiswa kwaye siya kuphelelwa ngoMeyi 27, 2024.

Kodwa, inkqubela ye-MDR ayizange ihambe kakuhle njengoko bekulindelekile, kwaye umgaqo-nkqubo wangoku umi ngolu hlobo lulandelayo,

Ngaphambi komhla wama-26 kuMeyi, 2024, amashishini kufuneka angenise isicelo se-MDR kumaqumrhu abo azisiwe, emva koko izatifikethi zabo ze-MDD (ii-IIb, IIa, kunye nezixhobo ze-I) zinokwandiswa ukuya kutsho kuDisemba 31, 2028.