Yakatumirwa 21 Kukadzi 2022 |NaNick Paul Taylor
Mapepa maviri matsva ekutungamira kubva kuEuropean Commission's Medical Device Coordination Group (MDCG) ane chinangwa chekupa rumwe ruzivo nezvekushandisa mitsva yemedtech mirau.
Chekutanga kumusoro igwaro kumitumbi yakaziviswa nezve verifying in vitro diagnostic (IVD) zvishandiso mukirasi D, iyo yakanyanya njodzi chikamu.Iyo inouya In Vitro Diagnostic Regulation (IVDR) inochengetera kirasi D yebvunzo dzinogona kuisa njodzi huru kune vese varwere uye hutano hweveruzhinji, senge zvigadzirwa zvinotarisa zvinotapurirana muropa kuti zviwedzerwe.Tichifunga nezvenjodzi, IVDR inoraira imwe yakaoma kuenderana yekuongorora maitiro ekirasi D IVD anosanganisira mitumbi yakaziviswa uye European Union referensi marabhoritari (EURL).
Sezvinotsanangurwa negwaro, mitumbi yakaziviswa inoda kuona mabheji ekirasi D IVDs.Verification inoda miviri yakaziviswa kuti ishande nevagadziri uye maEURL.
Vagadziri vanofanirwa kugovera mishumo yekirasi yavo D IVD bvunzo nemitumbi yavo yakaziviswa uye kuita kuti masampula awanikwe pakuongororwa.Mitumbi yakaziviswa ine basa rekuronga kuti maEURL aite batch test yemasampuli akapihwa.Mushure mekuita batch test, iyo EURL inogovera zvayawana neboka rakaziviswa.Kupedzwa kwedanho rekusimbisa kunobvisa mugadziri kuti atengese chishandiso, kunze kwekunge mutumbi wakaziviswa uchiratidzira dambudziko mukati memazuva makumi matatu ekugamuchira masampuli.
Nhungamiro yacho inopawo zano rekuti mitumbi yakaziviswa ingaite sei mabasa iwayo.Mitumbi yakaziviswa inoda maitiro akanyorwa ehurongwa hwekusimbisa, chirongwa chekuyedza chinovhara ese akakosha maparamita emudziyo, uye chibvumirano nemugadziri nezvesample logistics.
MDGC iri kuraira mitumbi yakaziviswa kuti ibatanidze chirongwa chekuyedza, chakatenderwa neEURL, icho chinovhara ruzivo senge masampuli achaongororwa, bvunzo frequency uye bvunzo chikuva chichashandiswa.Chibvumirano zvakare chinofanira kugadzirisa marogisiti ekuti vagadziri vanowana sei masampuli kumitumbi yavo yakaziviswa kana maEURL.Vagadziri vanofanira kuzvipira kuudza mitumbi yakaziviswa kana vakatumira sampuli zvakananga kuEURL uye kana vakaita shanduko dzinogona kukanganisa batch verification.
Nhungamiro yacho inobatawo chibvumirano chakanyorwa pakati peboka rakaziviswa neEURL.Zvekare, MDGC inotarisira kuti dare rakaziviswa risanganise chirongwa chebvunzo muchibvumirano.EURL-chaiyo chibvumirano chinodiwa zvinosanganisira kuisirwa mari yemurabhoritari uye yakatarwa nguva yekuedzwa uye kushuma zvakawanikwa.Iyo yakanyanya nguva yakatarwa mazuva makumi matatu.
Legacy mudziyo utariri
Rimwe zuva mushure mekuburitsa gwaro rekirasi D IVD, MDCG yakaburitsa gwara pamusoro pekuongororwa kwemidziyo yenhaka inotenderwa kugara pamusika weEU kusvika Chivabvu 2024 nezvitupa zvinoshanda zvakapihwa pasi peActive Implantable Medical Devices Directive (AIMDD) kana Medical Devices Directive (MDD) .
Nhungamiro inogadzirisa mubvunzo wakamutswa neMedical Device Regulation (MDR).Pasi peMDR, midziyo yenhaka inogona kugara pamusika weEU kusvika 2024 kana ikatevedzera mirairo yekare uye ikasaita shanduko dzakakura.Nekudaro, MDR inodawo midziyo yenhaka kuti isangane nezvinodiwa nemutemo pakutarisa mushure memusika, kutarisa kwemusika, kungwarira uye kunyoreswa kwevashandi vehupfumi.Tichifunga izvozvo, mitumbi yakaziviswa inofanirwa kubata sei ongororo yemhando dzekutonga masisitimu emidziyo yenhaka?
Nhungamiro yeMDCG inopindura mubvunzo iwoyo, ichiraira mitumbi yakaziviswa kuti itore nhoroondo yezvitsva zvinodiwa muhurongwa hwemabasa avo ekuongorora.Mukuita, izvo zvinoreva kuti MDCG inoda masangano akaziviswa kuti aongorore magwaro ehurongwa hwehutungamiriri hwemhando, achitarisa kana mugadziri akaita zvigadziriso zvinoenderana neMDR, obva ashandisa zvakabuda muongororo kuona chirongwa chekuongorora.
Sezvinongoita zvimwe zvinodiwa neMDR kumidziyo yenhaka, "zviitwa zvekuongorora zvichaitwa nemitumbi yakaziviswa zvinofanirwa kunge zviri kuenderera mberi kwezviitiko zvekuongorora zvakapfuura zvichitarisa pane zvitsva," nhungamiro inodaro.Vagadziri vanofanira kuita Periodic Safety Update Reports uye Post Market Surveillance zvirongwa uye mishumo inowanikwa kumitumbi yavo yakaziviswa kuitira kuti vagone "kuona kuti hurongwa hwekutonga hwemhando hwakagadziridzwa nemazvo uye hunoramba huchienderana nechitupa (s) chakapihwa pasi peMDD kana AIMDD. ”
Iyo yakasara yegwaro inotsanangura mamiriro emitumbi yakaziviswa inogona kusangana zvichienderana nekuti vagadziri varipi muMDR maitiro.Zano reMDCG remabatiro ekutarisa rinosiyana zvichienderana nekuti, semuenzaniso, mugadziri achabvisa mudziyo wake pamusika panosvika 2024 kana kuti atove akasimbiswa nerimwe sangano rakaziviswa pasi peMDR.
Nguva yekutumira: Mar-11-2022