Kuleli sonto senze ukuqeqeshwa ngemithetho ye-MDR.I-Hitec Medical ifaka isicelo sesitifiketi se-MDR CE futhi ilinganisela ukusithola ngoMeyi ozayo.

Sifunde ngenqubo yokuthuthukiswa kwemithetho ye-MDR.

Ngomhla zi-5 kuNhlaba wezi-2017, i-Official Journal of the European Union yakhipha ngokusemthethweni i-EU Medical Device Regulation (MDR) 2017/745.

Inhloso yalo mthethonqubo ukuqinisekisa ukuvikeleka okungcono kwezempilo yomphakathi kanye nokuphepha kwesiguli.I-MDR izongena esikhundleni se-Directives 90/385/EEC (Active Implantable Medical Device Directive) kanye ne-93/42/EEC (I-Medical Device Directive).Ngokwezidingo ze-Athikili 123 ye-MDR, i-MDR iqale ukusebenza ngokusemthethweni ngoMeyi 26, 2017 futhi yathatha indawo esemthethweni ye-MDD (93/42/EEC) kanye ne-AIMDD (90/385/EEC) ngoMeyi 26, 2020.

Ngenxa yomthelela we-COVID-19, isaziso sokubuyekezwa kosuku lwe-MDR yomthetho omusha we-EU MDR ngo-Ephreli 23, 2020 simemezele ngokusemthethweni ukuthi ukuqaliswa kwe-MDR kuhlehliselwe umhla zingama-26 kuNhlaba wezi-2021.

Kusukela ngomhla ka-May 26, 2021, zonke izisetshenziswa zezokwelapha ezisanda kwethulwa e-European Union kufanele zithobelane nezimfuneko ze-MDR.

Ngemuva kokuqaliswa kwe-MDR, kusengenzeka ukufaka isicelo sezitifiketi ze-CE ngokwe-MDD ne-AIMDD phakathi nesikhathi soguquko seminyaka emithathu futhi ugcine ukufaneleka kwezitifiketi.Ngokwe-Article 120 clause2, isitifiketi se-CE esikhishwe yi-NB ngesikhathi soshintsho sizohlala sisebenza, kodwa ngeke sidlule iminyaka emi-5 kusukela osukwini lwaso lokulethwa futhi sizophelelwa yisikhathi ngomhla ka-27 Meyi 2024.

Kodwa, inqubekelaphambili ye-MDR ayizange ihambe kahle njengoba bekulindelekile, futhi inqubomgomo yamanje imi kanje,

Ngaphambi komhla zingama-26 kuMeyi 2024, amabhizinisi kufanele athumele isicelo se-MDR emizimbeni yawo eyaziswayo, khona-ke izitifiketi zawo ze-MDD (amadivayisi e-IIb, IIa, kanye ne-I) zinganwetshwa kuze kube umhla zingama-31 kuZibandlela 2028.