na 28 th . Epril 2022, JoyTech bin gɛt initial isyu fɔ EU MDR fɔ wi nɔ-invasiv blɔd prɛshɔn monitɔ dɛn,yu kin fɛn di ditil dɛn naya.
Insay 2023, Joytech kɔntakt tɛmɔmɔta, nɔ kɔntakt tɛmɔmɔta ɛn nyu blɔd prɛshɔn monitɔ ɔl na di EU MDR dɔn gri fɔ.
Wetin na Ce(mdr)?
We i kam pan CE sɛtifiket, ɔlman sabi am. Klosap ɔl di industri dɛn gɛt kɔrɛspɔndɛns CE sɛtifiket. MDR na di shɔt we aw dɛn de shɔt di Yuropian mɛdikal divays rigyuleshɔn, we na di ɔpdet fɔ CE (MDD) ɛn i de put ay rikwaymɛnt dɛn pan di sef ɛn pefɔmɛns fɔ di 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 dairekt to rigyuleshɔn, di EU Mɛmba Stet dɛn go yuz strikt kɔntrol pan di sɛtifikeshɔn prɔses ɛn di rizɔlt dɛn.
Men wan de sho insay dɛn tin ya:
1) bin 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 dɛn (nɔbɔdi nɔ nid fɔ gɛt klia rikwaymɛn na di MDD Dairekt);
b) Di manifakta fɔ mek ɛn kɔntinyu fɔ ɔpdet tɛnki 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 to di inspekshɔn dɛn we dɛn nɔ dɔn anɔys bay di bɔdi dɛn we dɛn dɔn notis ɛni tɛm fɔ mek shɔ se dɛn ɔpdet di tɛknikal dɔkyumɛnt dɛn ɛn di mentenɛns fɔ 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 klasifikasiɔn lɔ dɛn: frɔm 18 na MDD to 22 na MDR;
b) Di besik rikwaymɛnt chɛklist aytem dɛn de inkrisayz: frɔm 13 tin dɛn na MDD to 23 tin dɛn na MDR;
c) Di strɔkchɔ fɔ CE tɛknikal dɔkyumɛnt dɛn dɔn chenj ɛn dɛn sheb am to: Prodakt Tɛknikal dɔkyumɛnt ɛn post-maket dɔkyumɛnt dɛn (MDD nɔmɔ nid fɔ gɛt prɔdak tɛknikal dɔkyumɛnt dɛn);
d) Klinik evalueshɔn ripɔt. MDR se kɔmni dɛn fɔ gi di nɔmba 4 vɛshɔn fɔ di klinik ɛvalueshɔn ripɔt dɛn, we strɛng pas di tɔd vɛshɔn;
3) Ekspand Skɔp fɔ Aplikeshɔn .
a) MDD de onli target prodakt wit medikal purpose, while MDR inklud som non-medical divais in di skop of aplikeshon, laik vegetable kontak lens, biuti prodakt, etc.;
b) Insay di MDD, dɛn kin klas di divays dɛn we dɛn kin yuz bak as klas fɔ mɛdikal divays ɛn dɛn nɔ nid fɔ mek wan bɔdi we dɛn notis, we di MDR nid fɔ mek wan notis bɔdi fɔ du kɔnfɔmiti asɛsmɛnt fɔ di ɔpreshɔn dɛn we dɛn kin yuz bak;
4) MDR nid fɔ gɛt mɔ transparency ɛn traceability .
a) introdyuz di yunik divais aydentifaya Udi fɔ inkrisayz prodak traceability;
b) Dɛn go gɛda di infɔmeshɔn we gɛt fɔ du wit di kɔmni insay di Yuropian Mɛdikal Divays Database (EudaMed);
c) Establish wan post-maket sovaylenshɔn (PMS) sistem;
d) Di notis bɔdi go du inspekshɔn dɛn we dɛn nɔ anɔys.
Wetin na di klinik evalueshɔn fɔ MDR CE?
Di klinik prɛktis we wi de tɔk bɔt na jɔs tu kayn we:
a) Dɛn kin yuz klinik trial pan mɔtalman fɔ gɛt data fɔ pruv di sef fɔ di prɔdak.
b) Klinik ripɔt dɛn men wan 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 di men kɔmpɔnɛnt bak (di klinik ɛvalueshɔn ripɔt na ripɔt we nɔ de chenj na di CE tɛknikal dɔkyumɛnt we dɛn de aplay fɔ CE sɛtifiket).
d) Naw, dɛn dɔn impruv di nɔmba 4 vɛshɔn fɔ di klinik ɛvalueshɔn ripɔt, we na klinik ɛvalueshɔn ripɔt we dɛn kɔmpilayt akɔdin to di Klinik Ɛvalueshɔn Gaydlain Meddev 2.7.1.
Pas MDR sertifikeyt min se . Joytech Blɔd Prɛshɔn Monitɔ ɛn . Dijital tɛmɔmɔta dɔn rich strikt standad dɛn fɔ disayn, prodakshɔn ɛn kwaliti kɔntrol, ɛn i kin gi sef ɛn mɔ rilibul mɛdikal divays to di wan dɛn we de yuz am ɔlsay na di wɔl.
Joytech Blɔd Prɛshɔn Monitɔ 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 go gɛt wan dawt fɔ mek di wan dɛn we de yuz am gɛt mɔ trɔst ɛn satisfay insay wi prɔdak dɛn.
Joytech Healthcare go kɔntinyu fɔ kɔmit fɔ gi . ay kwaliti mɛdikal divays ɛn kɔntribyut to di wɛlbɔdi fɔ di wan dɛn we de yuz am ɔlsay na di wɔl. Wi biliv se tru wi tray, wi kwaliti prodak dɛm go ɛp yu wɛlbɔdi layf na di glob ɔl makɛt.
If yu gɛt ɛni kwɛstyɔn ɔ nid bɔt wi blɔd prɛshɔn monitɔ ɛn tɛmɔmɔta prɔdak dɛm, duya fil fri fɔ kɔntakt wi.
