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I-EU ithumela iziqondiso zokuqinisekisa ama-IVD anobungozi obukhulu, ukugadwa kwamadivayisi wefa

Kuthunyelwe 21 February 2022 |Ibhalwe nguNick Paul Taylor

Imibhalo emibili emisha yokuqondisa evela ku-European Commission's Medical Device Coordination Group (MDCG) ihlose ukunikeza ulwazi olwengeziwe mayelana nokusebenzisa imithetho emisha ye-medtech.

Okokuqala isiqondiso semizimba eyazisiwe ekuqinisekiseni amadivayisi e-in vitro diagnostic (IVD) ekilasini D, isigaba esiyingozi kakhulu.I-In Vitro Diagnostic Regulation (IVDR) engenayo igodla isigaba D sokuhlola okungase kube yingozi enkulu kukho kokubili iziguli nempilo yomphakathi, njengemikhiqizo ehlola izinto ezithathelwanayo ezisegazini okufanele zimpontshelwe.Uma kubhekwa ubungozi, i-IVDR igunyaza inqubo yokuhlola ukuvumelana eyinkimbinkimbi yekilasi D IVD ehilela izindikimba ezazisiwe kanye namalabhorethri abhekisela e-European Union (EURL).

Njengoba isiqondiso sichaza, izindikimba ezazisiwe zidinga ukuqinisekisa amaqoqo ekilasi D IVD.Ukuqinisekisa kuzodinga izinhlangano ezazisiwe ukuthi zisebenze nabo bobabili abakhiqizi nama-EURL.

Abakhiqizi kufanele babelane ngemibiko yokuhlolwa kwe-IVD yekilasi labo nemizimba yabo eyazisiwe futhi benze amasampula atholakalele ukuhlolwa.Izindikimba ezazisiwe zinesibopho sokuhlela ama-EURLs ukwenza ukuhlolwa kwenqwaba yamasampuli anikeziwe.Ngemva kokwenza ukuhlolwa kwenqwaba, i-EURL izokwabelana ngokutholile nomzimba owazisiwe.Ukuqedwa kwesinyathelo sokuqinisekisa kusula umenzi ukuthi amakethe idivayisi, ngaphandle uma indikimba eyazisiwe ihlaba umkhosi inkinga zingakapheli izinsuku ezingu-30 zokuthola amasampula.

Umhlahlandlela uphinde unikeze izeluleko zokuthi izindikimba ezazisiwe zingahlangabezana kanjani nalezo zibopho.Izindikimba ezazisiwe zidinga izinqubo ezibhalwe phansi zenqubo yokuqinisekisa, uhlelo lokuhlola oluhlanganisa wonke amapharamitha wedivayisi abalulekile, kanye nesivumelwano nomkhiqizi mayelana nokusetshenziswa kwesampula.

I-MDGC yeluleka izinhlangano ezazisiwe ukuthi zifake uhlelo lokuhlola, olugunyazwe i-EURL, olufaka ulwazi olufana namasampuli azohlolwa, imvamisa yokuhlolwa kanye nenkundla yokuhlola ezosetshenziswa.Isivumelwano kufanele futhi sibhekane nokusetshenziswa kokuthi abakhiqizi bazowathola kanjani amasampula emizimbeni yabo eyaziswayo noma ama-EURL.Abakhiqizi kufanele bazibophezele ukutshela izinhlangano ezazisiwe uma bethumela amasampula ngokuqondile kuma-EURL futhi uma benza izinguquko ezingase zithinte ukuqinisekiswa kwenqwaba.

Isiqondiso siphinde sikhulume ngenkontileka ebhaliwe phakathi kwendikimba eyazisiwe ne-EURL.Futhi, i-MDGC ilindele indikimba eyazisiwe ukuthi ifake uhlelo lokuhlola esivumelwaneni.Izidingo zenkontileka eqondene ne-EURL zifaka phakathi ukufakwa kwezimali zaselabhorethri kanye nesilinganiso sesikhathi sokuhlola nokubika okutholakele.Isikhathi esiphezulu siyizinsuku ezingama-30.

Ukwengamela idivayisi eyifa

Ngolunye usuku ngemva kokukhipha idokhumenti yekilasi D IVD, i-MDCG ishicilele isiqondiso mayelana nokubhekwa kwemishini eyifa evunyelwe ukuhlala emakethe ye-EU kuze kube uMeyi 2024 enezitifiketi ezivumelekile ezikhishwe ngaphansi kwe-Active Implantable Medical Devices Directive (AIMDD) noma i-Medical Devices Directive (MDD) .

Umhlahlandlela ubhekana nombuzo ophakanyiswe yi-Medical Device Regulation (MDR).Ngaphansi kwe-MDR, amadivayisi ayigugu angahlala emakethe ye-EU kuze kube ngu-2024 uma ethobela iziqondiso ezindala futhi engenzi izinguquko ezibalulekile.Kodwa-ke, i-MDR iphinde idinge izisetshenziswa zefa ukuze zihlangabezane nezimfuneko zomthethonqubo mayelana nokugadwa kwangemva kwemakethe, ukubhekwa kwezimakethe, ukuqapha nokubhaliswa kwabasebenzi bezomnotho.Ngokunikezwa lokho, izinhlangano ezinolwazi kufanele zikuphathe kanjani ukugadwa kwezinhlelo zokuphatha ikhwalithi zamadivayisi ayigugu?

Isiqondiso se-MDCG siphendula lowo mbuzo, siyala izindikimba ezazisiwe ukuthi zicabangele izidingo ezintsha kuhlaka lwemisebenzi yazo yokugada.Empeleni, lokho kusho ukuthi i-MDCG ifuna izinhlangano ezazisiwe ukuthi zibuyekeze imibhalo yesistimu yokuphatha ikhwalithi, ihlole ukuthi umenzi wenze izinguquko ngokuhambisana ne-MDR, bese esebenzisa umphumela wokuhlola ukuze anqume uhlelo lokucwaninga.

Njengoba kuphela izimfuneko ezithile ze-MDR zisebenza kumadivayisi ayigugu, "imisebenzi yokucwaninga okufanele yenziwe izindikimba ezazisiwe kufanele ibe ukuqhubeka kwemisebenzi yokugada yangaphambilini ngokugxila ekuhlinzekweni okusha," isiqondiso sisho.Abakhiqizi kufanele benze Imibiko Yokubuyekeza Ukuphepha Kwezikhathi Nezikhathi kanye nezinhlelo Zokubhekwa Kwemakethe Yeposi kanye nemibiko itholakale emizimbeni yabo eyaziswayo ukuze “baqinisekise ukuthi isistimu yokuphatha ikhwalithi ishintshwe ngendlela efanele futhi ihlala ithobela izitifiketi ezikhishwe ngaphansi kwe-MDD noma i-AIMDD. ”

Esinye isiqondiso sichaza izimo izindikimba ezazisiwe ezingase zihlangabezane nazo kuye ngokuthi abakhiqizi bakuphi inqubo ye-MDR.Iseluleko se-MDCG mayelana nendlela yokubhekana nokubhekwa siyahluka kuye ngokuthi, ngokwesibonelo, umenzi uzolususa yini umshini wakhe emakethe ngo-2024 noma usevele ugunyazwe enye indikimba eyazisiwe ngaphansi kwe-MDR.


Isikhathi sokuthumela: Mar-11-2022