Nge- 28 .Ngo-Epreli ka-2022, iJoytech yafumana ukukhutshwa kokuqala kwe-EU MDR kubajongi bethu boxinzelelo lwegazi olungangeneleli, ungafumana iinkcukacha Apha.
Ngo-2023, i-thermometers zoqhagamshelwano ze-Joytech, i-thermometers ezingaqhagamshelani kunye kunye neemonitha zoxinzelelo lwegazi ezitsha zonke zivunyiwe yi-EU MDR.
Yintoni i-CE (MDR)?
Xa kuziwa kwizatifikethi zeCE, wonke umntu uqhelene nayo.Phantse lonke ishishini linesiqinisekiso se-CE esihambelanayo.I-MDR sisishunqulelo se-European Medical Device Regulation, ekuhlaziywa kwe-CE (MDD) kwaye ibeka iimfuno eziphezulu kukhuseleko kunye nokusebenza kwezixhobo zonyango.Siyibiza kwakhona i-CE (MDR).
Nguwuphi umahluko phakathi kwe-CE (MDD) kunye ne-CE (MDR)?
I-MDR ngummiselo kwaye i-MDD ngumyalelo.Ngenxa yokuba luphuculo, ukusuka kwizikhokelo ukuya kwimimiselo, amazwe angamalungu e-EU aya kusebenzisa ulawulo olungqongqo kwinkqubo yokuqinisekiswa kunye neziphumo.
Ibonakaliswa ikakhulu kule miba ilandelayo:
1) Ukuqinisa uxanduva lomenzi.
a) Umenzi kufuneka ubuncinane abe negosa elinye lokuthobela elinobugcisa kwinkalo yezixhobo zonyango (akukho mfuneko icacileyo kumyalelo we-MDD);
b) Umvelisi uya kuseka kwaye aqhubeke ehlaziya amaxwebhu obugcisa kwaye aqinisekise ukuba ayafumaneka xa eceliwe ngugunyaziwe onobuchule wesizwe.
c) Abavelisi kufuneka baphendule kuhlolo olungachazwanga ngamaqumrhu aziswe ngalo naliphi na ixesha ukuqinisekisa uhlaziyo lwamaxwebhu obugcisa kunye nokugcinwa kwenkqubo;(Iimveliso zeClass II)
d) Kwiimveliso ezinobungozi obuphezulu beenkampani zokurhweba, kuya kuba nzima ngakumbi ukufaka isicelo se-CE.
2) Ukwandiswa kwemimiselo yokulawula kunye nokuphononongwa kwesatifikethi esingqongqo.
a) Ukwandiswa kwemithetho yokuhlela: ukusuka kwi-18 kwi-MDD ukuya kwi-22 kwi-MDR;
b) Iimfuno ezisisiseko zoluhlu lwezinto zokukhangela ziyandiswa: ukusuka kwizinto ezili-13 kwi-MDD ukuya kwizinto ezingama-23 kwi-MDR;
c) Isakhiwo samaxwebhu obugcisa be-CE sitshintshile kwaye sahlulwe: amaxwebhu obugcisa bemveliso kunye namaxwebhu asemva kokuthengisa (i-MDD ifuna kuphela amaxwebhu obugcisa bemveliso);
d) Ingxelo yovavanyo lwezonyango.I-MDR ifuna ukuba iinkampani zinike ingxelo yesine yeengxelo zovavanyo lweklinikhi, olungqongqo kunenguqulelo yesithathu;
3) Umda owandisiweyo wesicelo
a) I-MDD ijolise kuphela kwiimveliso ezineenjongo zonyango, ngelixa i-MDR ibandakanya ezinye izixhobo ezingezizo ezonyango kumda wosetyenziso, ezifana neelensi zemifuno, iimveliso zobuhle, njl.njl.;
b) Kwi-MDD, izixhobo ezinokusetyenziswa kwakhona zihlelwa njengeklasi yezixhobo zonyango kwaye azifuni ukungenelela kwequmrhu elaziswayo, ngelixa i-MDR idinga iqumrhu elaziswayo ukuba liqhube uvavanyo lokuhambelana nezixhobo zotyando ezinokuphinda zisetyenziswe;
I-4) I-MDR ifuna ukucaca okukhulu kunye nokulandeleka
a) Yazisa i-UDI yokuchonga isixhobo esisodwa ukunyusa ukulandeleka kwemveliso;
b) Ulwazi olufanelekileyo lwenkampani luya kuqokelelwa kwi-European Medical Device Database (EUDAMED);
c) Ukuseka inkqubo yokucupha emva kokuthengisa (PMS);
d) Iqumrhu elazisiweyo liya kwenza uhlolo olungachazwanga.
Yintoni uvandlakanyo lwezonyango lwe-MDR CE?
Inkqubo yeklinikhi esithetha ngayo yahlulahlulwe ngokweendlela ezimbini:
a) Ulingo lwezonyango lusetyenziswa ebantwini ukufumana idatha ukubonisa ukhuseleko lwemveliso.
b) Iingxelo zeklinikhi ikakhulu zibonisa ukhuseleko kunye nokusebenza kwemveliso ngokuthelekisa imveliso (ukusuka kwimiba emithathu: idatha yeklinikhi, iiparitha zobugcisa, kunye nokusebenza kwebhayoloji), uhlalutyo lwedatha, kunye nokuphononongwa koncwadi.
c) Ingxelo yovavanyo lweklinikhi yinxalenye yoxwebhu lobuchwephesha lweCE kwaye ikwalicandelo eliphambili (ingxelo yovavanyo lweklinikhi yingxelo eyimfuneko kuxwebhu lobuchwephesha beCE xa ufaka isicelo sesiqinisekiso seCE).
d) Okwangoku, ingxelo yesine yengxelo yovavanyo lweklinikhi iphunyeziwe, eyingxelo yovavanyo lweklinikhi ehlanganiswe ngokuhambelana nesikhokelo sovavanyo lweklinikhi iMedDev 2.7.1.
Ukupasa isiqinisekiso se-MDR kuthetha ukuba Joytech esweni uxinzelelo lwegazi kunye Ithemometha yedijithali ifikelele kwimigangatho engqongqo kuyilo, imveliso kunye nolawulo lomgangatho, kwaye inokubonelela ngezixhobo zonyango ezikhuselekileyo nezithembekileyo kubasebenzisi kwihlabathi liphela.
Imonitha yoxinzelelo lwegazi ye-Joytech kunye nethemometha yedijithali iphumelele indumiso ngamxhelo mnye kubasebenzisi ngeziphumo zabo zokulinganisa ezichanekileyo, uyilo olusebenziseka lula kunye nokusebenza okugqwesileyo.Ngoku, bapasile isatifikethi se-MDR, esiya kuthi ngokungathandabuzekiyo sikhulise ukuthembela kwabasebenzisi kunye nokwaneliseka kwiimveliso zethu.
IJoytech Healthcare iya kuqhubeka izinikele ekuboneleleni izixhobo zonyango ezikumgangatho ophezulu kunye negalelo kwimpilo yabasebenzisi kwihlabathi liphela.Sikholelwa ukuba ngeenzame zethu, iimveliso zethu ezisemgangathweni ziya kuba luncedo kubomi bakho obusempilweni kwimarike yehlabathi.
Ukuba unayo nayiphi na imibuzo okanye iimfuno malunga nokujonga uxinzelelo lwegazi kunye neemveliso zethemometha, nceda uzive ukhululekile ukuqhagamshelana nathi.
