Ithunyelwe nge-21 kaFebruwari 2022 |NguNick Paul Taylor
Amaxwebhu amabini amatsha esikhokelo avela kwiQela loLungelelaniso lweSixhobo sezoNyango seKhomishini yaseYurophu (MDCG) ijolise ekuboneleleni ngolwazi oluthe kratya malunga nokusebenzisa imigaqo emitsha ye-medtech.
Okokuqala sisikhokelo kwimizimba eyazisiweyo ekuqinisekiseni izixhobo zokuxilonga kwi-vitro (IVD) kwiklasi D, udidi oluphezulu lomngcipheko.I-In Vitro Diagnostic Regulation (IVDR) engenayo igcina iklasi D kwiimvavanyo ezinokubeka umngcipheko omkhulu kuzo zombini izigulane kunye nempilo yoluntu, njengemveliso ehlola ii-agent ezithunyelwayo egazini ukuba zitofelwe.Xa kujongwa imingcipheko, i-IVDR igunyazisa inkqubo yovavanyo olunzima ngakumbi lwe-IVD yeklasi ye-D ebandakanya amaqumrhu azisiweyo kunye neelebhu zesalathiso ze-European Union (EURL).
Njengoko isikhokelo sicacisa, amaqumrhu azisiweyo kufuneka aqinisekise iibhetshi zeeklasi ze-D IVDs.Ukuqinisekiswa kuya kufuna imibutho eyazisiweyo ukuba isebenze kunye nabavelisi kunye nee-EURLs.
Abavelisi kufuneka babelane ngeengxelo zovavanyo lwe-IVD yeklasi yabo kunye nemizimba yabo eyazisiweyo kwaye benze iisampuli zifumaneke kuvavanyo.Imibutho eyazisiweyo inoxanduva lokulungiselela ii-EURLs ukwenza uvavanyo lwebhetshi yeesampuli ezinikiweyo.Emva kokwenza uvavanyo lwebhetshi, i-EURL iya kwabelana ngeziphumo zayo kunye nomzimba owazisiweyo.Ukugqitywa kwenyathelo lokuqinisekisa kucoca umenzi ukuba athengise isixhobo, ngaphandle kokuba umzimba owazisiweyo ubonisa ingxaki phakathi kweentsuku ezingama-30 zokufumana iisampulu.
Isikhokelo sikwabonelela ngeengcebiso malunga nokuba amaqumrhu azisiweyo angahlangabezana njani na nolo xanduva.Imibutho eyazisiweyo idinga iinkqubo ezibhaliweyo zenkqubo yokuqinisekisa, isicwangciso sovavanyo esibandakanya zonke iiparamitha zesixhobo esibalulekileyo, kunye nesivumelwano nomvelisi malunga nesampulu yolungiselelo lolungiselelo.
I-MDGC icebisa imibutho eyazisiweyo ukuba ibandakanye isicwangciso sovavanyo, esivunywe yi-EURL, equka ulwazi olufana neesampuli eziza kuvavanywa, uvavanyo oluphindaphindiweyo kunye neqonga lokuvavanya eliza kusetyenziswa.Isivumelwano kufuneka sijongane nendlela abavelisi abaza kufumana ngayo iisampulu kumaqumrhu abo azisiweyo okanye ii-EURLs.Abavelisi kufuneka bazibophelele ekuxeleleni imibutho eyazisiweyo ukuba bathumela iisampulu ngqo kwii-EURLs kwaye ukuba benza utshintsho olunokuthi luchaphazele ukuqinisekiswa kwebhetshi.
Isikhokelo sikwajongana nekhontrakthi ebhaliweyo phakathi kwebhodi eyazisiweyo kunye ne-EURL.Kwakhona, i-MDGC ilindele ukuba umzimba owazisiweyo ubandakanye isicwangciso sovavanyo kwisivumelwano.Iimfuno zekhontrakthi ezikhethekileyo ze-EURL ziquka ukubandakanywa kweentlawulo zelabhoratri kunye nexesha eliqikelelwayo lokuvavanya kunye nokunika ingxelo ngeziphumo.Elona xesha limiselweyo ziintsuku ezingama-30.
Ukongamela isixhobo selifa
Ngolunye usuku emva kokukhulula uxwebhu lwe-D IVD yeklasi, i-MDCG yapapasha isikhokelo malunga nokucupha izixhobo zelifa ezivunyelwe ukuba zihlale kwimarike ye-EU kude kube ngoMeyi 2024 kunye neziqinisekiso ezisemthethweni ezikhutshwe phantsi kwe-Active Implantable Medical Devices Directive (AIMDD) okanye i-Medical Devices Directive (MDD) .
Isikhokelo sijongana nombuzo ophakanyiswe yiMedical Device Regulation (MDR).Ngaphantsi kwe-MDR, izixhobo zelifa zinokuhlala kwimarike ye-EU kude kube yi-2024 ukuba zithobela imiyalelo yakudala kwaye azenzi utshintsho olubalulekileyo.Nangona kunjalo, i-MDR ikwafuna izixhobo zelifa ukuze ihlangabezane neemfuno zommiselo kuphononongo lwasemva kwemarike, ukubekw' esweni kwemarike, ukugada kunye nokubhaliswa kwabasebenzi bezoqoqosho.Ukunikwa oko, amaqumrhu azisiweyo kufuneka aluphathe njani uphononongo lweenkqubo zolawulo lomgangatho wezixhobo zelifa?
Isikhokelo se-MDCG siyawuphendula loo mbuzo, siyalela amaqumrhu azazisiweyo ukuba athathele ingqalelo iimfuno ezitsha kwisikhokelo semisebenzi yokucupha.Enyanisweni, oko kuthetha ukuba i-MDCG ifuna ukuba amaqumrhu azisiwe ukuba ahlolisise amaxwebhu enkqubo yokulawula umgangatho, ukujonga ukuba ngaba umenzi wenze uhlengahlengiso ngokuhambelana ne-MDR, kwaye emva koko asebenzise umphumo wovavanyo ukumisela inkqubo yophicotho.
Njengoko kuphela iimfuno ezithile ze-MDR zisebenza kwizixhobo zelifa, "imisebenzi yophicotho-zincwadi ekufuneka yenziwe ngamaqumrhu azisiweyo kufuneka ibe kukuqhubela phambili kwemisebenzi yangaphambili yokucupha ngokugxila kwimimiselo emitsha," isikhokelo sichaza.Abavelisi kufuneka benze iiNgxelo zoHlaziyo loKhuseleko lweXesha kunye nezicwangciso zePost Market Surveillance kunye neengxelo zifumaneke kumaqumrhu abo azisiweyo ukuze “baqinisekise ukuba inkqubo yolawulo lomgangatho iye yahlengahlengiswa ngokufanelekileyo kwaye ihlala ithobela isatifikethi (izi)tifiketi esikhutshwe phantsi kwe-MDD okanye i-AIMDD. ”
Esinye isikhokhelo sichaza iimeko apho amaqumrhu azisiweyo anokuqubisana nawo ngokuxhomekeke ekubeni baphi abavelisi kwinkqubo ye-MDR.Iingcebiso ze-MDCG malunga nendlela yokujongana nokucupha ziyahluka ngokuxhomekeke ekubeni, umzekelo, umenzi uya kusisusa isixhobo sakhe kwimarike ngo-2024 okanye sele eqinisekisiwe lelinye iqumrhu elaziswayo phantsi kwe-MDR.
Ixesha lokuposa: Mar-11-2022