Na di 28 dez . Epril 2022, Joytech bin gɛt initial ishu fɔ EU MDR fɔ wi nɔ-invasive blɔd prɛshɔn monita dɛn,yu kin fɛn di ditel dɛn naya.
Insay 2023, Joytech kɔntakt tɛmɔmɔta, nɔ kɔntakt tɛmɔmɔta ɛn nyu blɔd prɛshɔn monita ɔl na EU MDR apruv.
Wetin na CE(MDR)?
We i kam pan CE sɛtifiket, ɔlman sabi am. Klosap ɛvri industri gɛt kɔrɛspɔndɛns CE sɛtifiket. MDR na di abbrevieshɔn fɔ Yuropian Mɛdikal Divays Rɛgyuleshɔn, we na di ɔpdet fɔ CE (MDD) ɛn i de put ay rikwaymɛnt pan di sef ɛn pefɔmɛns fɔ mɛdikal divays dɛn. Wi kin kɔl am bak CE(MDR).
Wetin na di difrɛns bitwin CE(MDD) ɛn CE(MDR)?
MDR na rigyuleshɔn ɛn MDD na dairekt. Bikɔs na ɔpgrɛd, frɔm dairektv to rigyuleshɔn, di EU mɛmba stet dɛn go yuz strikt kɔntrol pan di sɛtifikeshɔn prɔses ɛn di rizɔlt.
Di men tin we dɛn kin sho pan dɛn tin ya:
1) I mek di manifakta in wok strɔng.
a) Di manifakta fɔ gɛt at le wan kɔmplians ɔfisa we gɛt ɛkspɛriɛns pan di fild fɔ mɛdikal divays (no klia rikwaymɛnt nɔ de na di MDD dairektv);
b) Di manifakta fɔ mek ɛn kɔntinyu fɔ ɔpdet tɛknikal dɔkyumentri ɛn mek shɔ se i de we di nashɔnal kɔmpiten ɔtoriti aks fɔ am.
c) Di wan dɛn we de mek di tin dɛn fɔ ansa di inspekshɔn dɛn we dɛn nɔ dɔn anɔys we di bɔdi dɛn we dɛn notis dɔn du ɛni tɛm fɔ mek shɔ se dɛn ɔpdet di tɛknikal dɔkyumɛnt dɛn ɛn mentenɛns di sistɛm; (Klas II prodakt dɛn)
d) Fɔ ay-risk prodak dɛm fɔ tredin kɔmni dɛm, i go at fɔ aplay fɔ CE.
2) Inkris rigyuletɔri prɔvishɔn ɛn strikt sɛtifikeshɔn rivyu.
a) Inkris klasification rules: frɔm 18 na MDD to 22 na MDR;
b) Dɛn inkrisayz di besik rikwaymɛnt chɛklist aytem dɛn: frɔm 13 aytem dɛn na MDD to 23 aytem dɛn na MDR;
c) Di strɔkchɔ fɔ CE tɛknikal dɔkyumɛnt dɛn dɔn chenj ɛn dɛn sheb am to: prodak tɛknikal dɔkyumɛnt ɛn post-makɛtin dɔkyumɛnt (MDD jɔs nid prodak tɛknikal dɔkyumɛnt);
d) Klinik evalueshɔn ripɔt. MDR se di kɔmni dɛn fɔ gi di nɔmba 4 vɛshɔn fɔ di klinik ɛvalueshɔn ripɔt, we strɛng pas di tɔd vɛshɔn;
3) Dɛn dɔn ɛkspɛn di skɔp fɔ aplikeshɔn
a) MDD de jɔs tɔch di prɔdak dɛn we gɛt mɛrɛsin, we MDR inklud sɔm divays dɛn we nɔto mɛrɛsin insay di skɔp fɔ aplikeshɔn, lɛk vɛjitebul kɔntakt lens, biuti prɔdak, ɛn ɔda tin dɛn;
b) Insay di MDD, dɛn kin klas divays dɛn we dɛn kin yuz bak as wan klas fɔ mɛdikal divays dɛn ɛn dɛn nɔ nid fɔ mek bɔdi we dɛn notis, we di MDR nid bɔdi we dɛn notis fɔ du kɔnfɔmiti asɛsmɛnt fɔ ɔspitul divays dɛn we dɛn kin yuz bak;
4) MDR nid fɔ gɛt mɔ transparency ɛn traceability
a) Introdyus di yunik divays aydentifaya UDI fɔ inkrisayz prodakt traysabiliti;
b) Dɛn go gɛda di infɔmeshɔn we gɛt fɔ du wit di kɔmni na di Yuropian Mɛdikal Divays Database (EUDAMED);
c) Fɔ mek wan post-maket sɔvɛlayshɔn (PMS) sistɛm;
d) Di bɔdi we dɛn notis go du inspekshɔn we dɛn nɔ anɔys.
Wetin na di klinik evalueshɔn fɔ MDR CE?
Di klinik prɔsis we wi de tɔk bɔt, dɛn kin sheb am to tu kayn we:
a) Dɛn kin yuz klinik trial pan mɔtalman fɔ gɛt data fɔ pruv se di prɔdak sef.
b) Klinik ripɔt dɛn men wan de pruv di sef ɛn ɛfɛktiv we di prɔdak gɛt tru di prɔdak kɔmpiashɔn (frɔm tri aspek dɛn: klinik data, tɛnki paramita, ɛn bayolojikal pefɔmɛns), data analisis, ɛn litrɛcha rivyu.
c) Di klinik evalueshɔn ripɔt na pat pan di CE tɛknikal dɔkyumɛnt ɛn na wan impɔtant kɔmpɔnɛnt bak (di klinik ɛvalueshɔn ripɔt na ripɔt we nɔ impɔtant na di CE tɛknikal dɔkyumɛnt we yu de aplay fɔ CE sɛtifiket).
d) Naw, dɛn de impruv di nɔmba 4 vɛshɔn fɔ di klinik ɛvalueshɔn ripɔt, we na klinik ɛvalueshɔn ripɔt we dɛn kɔmpilayt akɔdin to di klinik ɛvalueshɔn gaydlayn MedDev 2.7.1.
Fɔ pas MDR sɛtifiket min se Joytech blɔd prɛshɔn monitɔ ɛn dijital tɛmɔmɔta dɔn rich strikt standad pan dizayn, prodakshɔn ɛn kwaliti kɔntrol, ɛn i kin gi mɛrɛsin divays dɛn we sef ɛn we pɔsin kin abop pan to di wan dɛn we de yuz am ɔlsay na di wɔl.
Joytech blɔd prɛshɔn monita ɛn dijital tɛmɔmɔta dɔn win unanimi prez frɔm di wan dɛn we de yuz am fɔ dɛn kɔrɛkt mɛzhɔmɛnt rizɔlt, yuz-frenli dizayn ɛn fayn fayn pefɔmɛns. Naw, dɛn dɔn pas di MDR sɛtifiket, we nɔ gɛt wan dawt se go mek di wan dɛn we de yuz am gɛt mɔ trɔst ɛn satisfayshɔn pan wi prɔdak dɛn.
Joytech Healthcare go kɔntinyu fɔ de wok tranga wan fɔ gi ay kwaliti mɛrɛsin divays dɛn ɛn we de ɛp fɔ mek di wan dɛn we de yuz am ɔlsay na di wɔl gɛt wɛlbɔdi. Wi biliv se tru wi tray, wi kwaliti prodak dɛm go ɛp yu fɔ gɛt wɛlbɔdi layf na di glob ɔl makit.
If yu gɛt ɛni kwɛstyɔn ɔ nid bɔt wi blɔd prɛshɔn monita ɛn tɛmɔmɔta prɔdak, duya fil fri fɔ kɔntakt wi.
