Yolembedwa pa February 21, 2022 |Wolemba Nick Paul Taylor
Zolemba ziwiri zatsopano zotsogola zochokera ku European Commission's Medical Device Coordination Group (MDCG) zikufuna kupereka zambiri zokhudzana ndi kugwiritsa ntchito malamulo atsopano a medtech.
Choyamba ndikuwongolera kwa mabungwe odziwitsidwa pakutsimikizira zida za in vitro diagnostic (IVD) mukalasi D, gulu lomwe lili pachiwopsezo chachikulu.Incoming In Vitro Diagnostic Regulation (IVDR) imasungira kalasi D kuti ipeze mayeso omwe angapangitse chiopsezo chachikulu kwa odwala komanso thanzi la anthu, monga mankhwala omwe amafufuza kuti athandizidwe m'magazi kuti atsitsidwe.Potengera kuopsa kwake, IVDR imalamula kuti pakhale njira yovuta yowunikira ma IVD a m'kalasi ya D yomwe imakhudza mabungwe azidziwitso ndi European Union reference laboratories (EURL).
Monga momwe upangiri ukufotokozera, mabungwe odziwitsidwa amayenera kutsimikizira magulu a ma IVD amtundu wa D.Kutsimikizira kudzafunika mabungwe odziwitsidwa kuti agwire ntchito ndi onse opanga ndi ma EURL.
Opanga ayenera kugawana malipoti a mayeso awo a kalasi ya D IVD ndi matupi awo odziwitsidwa ndikupanga zitsanzo kuti ziyesedwe.Mabungwe odziwitsidwa ali ndi udindo wokonzekera ma EURL kuti ayese kuyesa kwamagulu a zitsanzo zomwe zaperekedwa.Pambuyo poyesa batch, EURL idzagawana zomwe zapeza ndi bungwe lodziwitsidwa.Kutsiliza kwa sitepe yotsimikizira kumasula wopanga kuti agulitse chipangizocho, pokhapokha ngati bungwe lodziwitsidwa likuwonetsa vuto mkati mwa masiku 30 atalandira zitsanzo.
Upangiriwu umaperekanso upangiri wa momwe mabungwe odziwitsidwa angakwaniritsire maudindowo.Mabungwe odziwitsidwa amafunikira ndondomeko zolembedwa zotsimikizira, dongosolo loyesera lomwe limakhudza magawo onse ofunikira pazida, komanso mgwirizano ndi wopanga pazokhudza zitsanzo.
MDGC ikulangiza mabungwe odziwitsidwa kuti aphatikize dongosolo loyesera, lovomerezedwa ndi EURL, lomwe limafotokoza zambiri monga zitsanzo zoyesedwa, maulendo oyesa komanso malo oyesera omwe agwiritsidwe ntchito.Mgwirizanowu uyeneranso kuthana ndi momwe opanga angapezere zitsanzo kumabungwe odziwitsidwa kapena ma EURL.Opanga akuyenera kudzipereka kuuza mabungwe odziwitsidwa ngati atumiza zitsanzo ku ma EURL komanso ngati asintha zomwe zingakhudze kutsimikizika kwa batch.
Chitsogozochi chimakhudzanso mgwirizano wolembedwa pakati pa bungwe lodziwitsidwa ndi EURL.Apanso, MDGC ikuyembekeza kuti bungwe lodziwitsidwa liphatikizepo ndondomeko yoyesera mu mgwirizano.Zofunikira zokhudzana ndi mgwirizano wa EURL zimaphatikizanso kuphatikizidwa kwa chindapusa cha labotale komanso nthawi yoyezetsa ndikupereka lipoti zomwe zapezeka.Nthawi yochuluka ndi masiku 30.
Kuyang'anira zida zomwe zidachitika kale
Tsiku lina atatulutsa chikalata cha kalasi ya D IVD, MDCG idasindikiza malangizo okhudza kuyang'anira zida zakale zomwe zimaloledwa kukhala pamsika wa EU mpaka Meyi 2024 ndi ziphaso zovomerezeka zoperekedwa pansi pa Active Implantable Medical Devices Directive (AIMDD) kapena Medical Devices Directive (MDD) .
Upangiriwu ukuyankha funso lomwe lidadzutsidwa ndi Medical Device Regulation (MDR).Pansi pa MDR, zida zotengera cholowa zimatha kukhalabe pamsika wa EU mpaka 2024 ngati zitsatira malangizo akale ndipo sizisintha kwambiri.Komabe, MDR imafunanso zida zomwe zidakhazikitsidwa kuti zikwaniritse zofunikira zamalamulo pazowunikira pambuyo pa msika, kuyang'anira msika, kuyang'anira ndi kulembetsa oyendetsa zachuma.Poganizira izi, kodi mabungwe odziwitsidwa ayenera kuchita bwanji kuyang'anira kasamalidwe kabwino ka zida zakale?
Malangizo a MDCG amayankha funsoli, ndikulangiza mabungwe odziwitsidwa kuti aganizire zofunikira zatsopano mu ndondomeko ya ntchito zawo zowunikira.M'malo mwake, izi zikutanthauza kuti MDCG ikufuna mabungwe odziwitsidwa kuti awonenso zolembedwa zamakina owongolera, kuyang'ana ngati wopangayo wasintha mogwirizana ndi MDR, ndiyeno agwiritse ntchito zotsatira za kafukufukuyu kuti adziwe pulogalamu yowunikira.
Monga momwe zofunikira zina za MDR zimagwira ntchito pazida zomwe zakhazikitsidwa kale, "ntchito zowunikira zomwe ziyenera kuchitidwa ndi mabungwe azidziwitso ziyenera kukhala kupitiriza kuyang'anira zomwe zachitika m'mbuyomu poyang'ana zomwe zaperekedwa," akutero malangizowo.Opanga akuyenera kupanga malipoti a Periodic Safety Update and Post Market Surveillance mapulani ndi malipoti kuti apezeke ku mabungwe awo odziwitsidwa kuti athe "kutsimikizira kuti kasamalidwe kabwino kachitidwe kasinthidwa moyenera ndipo amakhalabe wogwirizana ndi satifiketi yoperekedwa pansi pa MDD kapena AIMDD. ”
Maupangiri ena onse amafotokoza zochitika zomwe mabungwe azidziwitso angakumane nazo kutengera komwe opanga ali munjira ya MDR.Malangizo a MDCG okhudza momwe angayandikire amasiyana malinga ngati, mwachitsanzo, wopanga adzachotsa chipangizo chake pamsika pofika 2024 kapena atsimikiziridwa kale ndi bungwe lina lodziwitsidwa pansi pa MDR.
Nthawi yotumiza: Mar-11-2022