Nge-28 th . Ngomhla wamashumi amabini anesifo-2022, uJoytech wafumana ukukhutshwa kwe-EU MDR kwi-ofisi yethu engahlambululanga, ungazifumanisa iinkcukacha Apha.
Ngowama-2023, uJoytech nxibelelana ne-thermometers, angaqhagamshelana ne-thermometers kunye neemonitore ezintsha zegazi zonke i-EU MDR ivunyiwe.
Yintoni i-CE (MDR)?
Xa kufikwa kwizatifikethi zezatifikethi, wonke umntu uyayazi loo nto. Phantse wonke umzi mveliso unesatifikethi esihambelana ne-CE. I-MDR sisifinyezo semigaqo yesixhobo se-Europe yaseYurophu, ehlaziyiweyo ye-CE (i-MDD) kwaye ibeka iimfuno eziphezulu kwokhuseleko kunye nokusebenza kwezixhobo zonyango. Sikwabiza ngokuba yi-CE (MDR).
Yintoni umahluko phakathi kwe-CE (MD) noCE (MDR)?
I-MDR ngummiselo kwaye i-MDD sisikhokelo. Kuba kukuphuculwa, kwimiyalelo yeMigaqo, amazwe e-EU aya kusebenzisa ulawulo olubekiweyo kwinkqubo yokuqinisekiswa kunye neziphumo.
Ikakhulu kuboniswe kule miba ilandelayo:
1) Ukomeleza uxanduva loMvelisi.
a) Umenzi kufuneka abe negosa elinye lokuthobela kunye nobungcali kwicandelo lezixhobo zonyango (akukho mfuneko icacileyo kwi-MDD);
b) Umvelisi uya kuseka kwaye aqhubeke nokuhlaziya amaxwebhu obuchwephesha kwaye aqinisekise ukuba iyafumaneka xa icelwe ligunya elinobuchule belizwe.
c) Abavelisi kufuneka baphendule kuhlolo olungakhange baqinisekisiwe ngamaqumrhu olwaziweyo ngalo naliphi na ixesha ukuqinisekisa ukuhlaziywa kwamaxwebhu ezobugcisa kunye nokugcinwa kwenkqubo; (Iimveliso zeklasi zeklasi)
d) Iimveliso ezisemngciphekweni omkhulu weenkampani zokurhweba, kuya kuba nzima ngakumbi ukufaka isicelo sowe-CE.
2) Ukonyusa imigqaliselo yolawulo kunye nokuphononongwa kwesiqinisekiso.
a) Ukwanda kwemithetho yokuhlela: Ukususela nge-18 eMdd ukuya kwi-22 kwi-MDR;
b) Izinto ezisisiseko zokutshekisha iimfuno zoluhlu lwezinto ezifushekayo ziyanda: ukusuka kwizinto ezili-13 kwi-MDD ukuya kwezi-23 ze-MDR;
c) Ubume bamaxwebhu obuchwephesha bece butshintshiwe kwaye bahlulwe baba ngamaxwebhu obuchwephesha bobuchwephesha kunye namaxwebhu okuthengisa emva (i-MD kuphela ifuna kuphela amaxwebhu obuchwephesha kwimveliso);
d) Ingxelo yovavanyo lweklinikhi. I-MDR ifuna iinkampani ukuba zinikezele ngohlobo lwesine lweengxelo zovavanyo zeklinikhi, ezingqonge ngakumbi kunenguqulelo yesithathu;
3) Ubungakanani besicelo
a) I-A) I-MDD ijolise kwiimveliso zezonyango, ngelixa i-MDR ibandakanya ezinye izixhobo ezingezizonyango kumda wesicelo, njengeelensi zonxibelelwano, iimveliso zobuhle, njl.;
b) kwi-MDD, izixhobo ezinokuphinda zisebenze zihlelwe njengeklasi yezixhobo zonyango kwaye azifuni ukuba ungenelelo lomzimba oqinisekisiweyo, ngelixa i-MDR ifuna umzimba oqinisekisiweyo wokuqhutywa kovavanyo lokuvumelanisa izinto ezinokutya.
I-4) I-MDR ifuna ukungafihli kunye nokulandelela
a) wazisa isikhombisi esikhethekileyo se-UDI ukwandisa ukulandelela kwemveliso;
b) Ulwazi olufanelekileyo lwenkampani luya kuqokelelwa kwindawo yedatha ye-Europe yaseYurophu (Eudd);
c) ukuseka inkqubo yentengiso yasemva kwemarike (i-PMS);
d) Umzimba oqinisekisiweyo uya kuqhuba uhlolo olungathethekiyo.
Luluphi uvavanyo lweklinikhi lwe-MDR CE?
Intshukumo yeklinikhi esithetha ngayo ihlulwe ngokubanzi ibe ziifom ezimbini:
a) Iimvavanyo zeklinikhi zisetyenziselwa abantu ukufumana idatha ukubonisa ukhuseleko lwemveliso.
b) Iingxelo zeklinikhi zingqina ikakhulu ukhuseleko kunye nokusebenza kwemveliso ngokubhekisele kwimveliso (ukusuka kwimiba emithathu: Idatha yezonyango, uhlalutyo lwedatha, kunye nokuhlaziywa kwedatha, kunye nokuhlaziywa kweenkcukacha, kunye novavanyo lwedatha, kunye novavanyo lwedatha, kunye novavanyo lwedatha, kunye nokuhlaziywa kweenkcukacha, kunye nokuhlaziywa kwedatha, kunye nokuhlaziywa kweenkcukacha, kunye novavanyo lwedatha, kunye novavanyo lwedatha, kunye novavanyo lwedatha, kunye nokuhlaziywa kwedatha, kunye nokuhlaziywa kwedatha, kunye nokuhlaziywa kwedatha, kunye nokuhlaziywa kwedatha, kunye novavanyo lwedatha.
c) Ingxelo yovavanyo lweklinikhi yinxalenye yoxwebhu lobugcisa be-CE kwaye ikwalicandelo eliphambili (Ingxelo yoVavanyo lweKlinikhi yingxelo ebonakalayo kuxwebhu lobugcisa be-CE).
d) Okwangoku, inguqulelo yesine yeNgxelo yoVavanyo lweKlinikhi yeklinikhi iphunyezwa, eyingxelo yovavanyo lweklinikhi edityaniswe ngokungqinelana nesikhokelo sovavanyo lweklinikhi iMeddev 2.7.1.
Ukuthengiswa kwe-MDR kuthetha ukuba I-Jaytech I- IXESHA LOKUGQIBELA HARD YOKUGQIBELA I-Digital Thermometer ifikelele kwimigangatho engqongqo kuyilo, ukuvelisa kunye nolawulo lomgangatho, kwaye kunokubonelela ngezixhobo ezikhuselekileyo nezithembakeleyo zonyango ezinokuthenjwa kubasebenzisi kwihlabathi liphela.
I-Jaytech Ingcinezelo yegazi kunye ne-thermometer yedijithali iphumelele indumiso ye-Unimaous evela kubasebenzisi ngemilinganiselo yabo echanekileyo, uyilo olusebenziseka lula kunye nokusebenza kakuhle. Ngoku, badlulile isiqinisekiso se-MDR, esingahambelani nophindaphindiweyo bokuphucula ukuthembana kwabasebenzisi kunye nolwaneliseko kwiimveliso zethu.
I-Joytech Healthycare iya kuqhubeka nokuzibophelela ekuboneleleni Izixhobo zonyango ezisemgangathweni kunye negalelo kwimpilo yabasebenzisi kwihlabathi liphela. Siyakholelwa ukuba ngenzame zethu, iimveliso zethu zomgangatho ziya kuba luncedo ebomini bakho obunempilo kwimarike yehlabathi.
Ukuba unayo nayiphi na imibuzo okanye iimfuno malunga noxinzelelo lwegazi lwegazi kunye neemveliso ze-thermometer, nceda ukhululeke ukunxibelelana nathi.
