E ngotsoe 21 Hlakola 2022 |E ngotsoe ke Nick Paul Taylor
Litokomane tse peli tse ncha tsa tataiso tse tsoang ho European Commission's Medical Device Coordination Group (MDCG) li ikemiselitse ho fana ka boitsebiso bo eketsehileng mabapi le ho sebelisa melaoana e mecha ea medtech.
Taba ea pele ke tataiso ho mekhatlo e tsebisitsoeng mabapi le ho netefatsa lisebelisoa tsa tlhahlobo ea in vitro (IVD) sehlopheng sa D, sehlopha se kotsi ka ho fetisisa.In Vitro Diagnostic Regulation (IVDR) e tlang e bolokile sehlopha sa D bakeng sa liteko tse ka behang kotsi e kholo ho bakuli le bophelo bo botle ba sechaba, joalo ka lihlahisoa tse hlahlobang hore na ho na le lintho tse fetisoang maling hore li ka tšeloa.Ka lebaka la likotsi, IVDR e laela hore ho be le tlhahlobo e rarahaneng ea ho lumellana le maemo bakeng sa li-IVD tsa sehlopha sa D tse kenyeletsang mekhatlo e tsebisitsoeng le lilaboratories tsa litšupiso tsa European Union (EURL).
Joalo ka ha tataiso e hlalosa, mekhatlo e tsebisitsoeng e hloka ho netefatsa lihlopha tsa li-IVD tsa sehlopha sa D.Netefatso e tla hloka hore mekhatlo e tsebisitsoeng e sebetse le bahlahisi le li-EURL.
Baetsi ba tlameha ho arolelana litlaleho tsa liteko tsa bona tsa sehlopha sa D IVD le mekhatlo ea bona e tsebisitsoeng le ho etsa hore lisampole li fumanehe bakeng sa tlhahlobo.Mekhatlo e tsebisitsoeng e na le boikarabello ba ho hlophisa hore li-EURL li etse tlhahlobo ea batch ea lisampole tse fanoeng.Kamora ho etsa tlhahlobo ea batch, EURL e tla arolelana seo e se fumaneng le sehlopha se tsebisitsoeng.Ho phetheloa ha mohato oa netefatso ho hlakisa moetsi ho bapatsa sesebelisoa, ntle le haeba 'mele o tsebisitsoeng o tšoaea bothata nakong ea matsatsi a 30 ka mor'a ho amohela lisampole.
Tataiso e boetse e fana ka likeletso mabapi le hore na mekhatlo e tsebisitsoeng e ka phethahatsa boikarabelo boo joang.Mekhatlo e tsebisitsoeng e hloka lits'ebetso tse tlalehiloeng bakeng sa ts'ebetso ea netefatso, leano la tlhahlobo le akaretsang likarolo tsohle tsa bohlokoa tsa lisebelisoa, le tumellano le moetsi mabapi le lisebelisoa tsa sampole.
MDGC e eletsa mekhatlo e tsebisitsoeng ho kenyelletsa leano la liteko, le amohetsoeng ke EURL, le akaretsang tlhahisoleseling joalo ka lisampole tse lokelang ho lekoa, makhetlo a liteko le sethala sa liteko se tla sebelisoa.Tumellano e boetse e lokela ho sebetsana le maemo a hore na bahlahisi ba tla fumana lisampole joang mekhatlong ea bona e tsebisitsoeng kapa li-EURL.Baetsi ba lokela ho itlama ho bolella mekhatlo e tsebisitsoeng haeba ba romela lisampole ka kotloloho ho li-EURL le haeba ba etsa liphetoho tse ka amang netefatso ea sehlopha.
Tataiso e boetse e bua ka konteraka e ngotsoeng lipakeng tsa sehlopha se tsebisitsoeng le EURL.Hape, MDGC e lebeletse hore sehlopha se tsebisitsoeng se kenyelle moralo oa teko tumellanong.Litlhoko tsa konteraka tse khethehileng tsa EURL li kenyelletsa ho kenyelletsoa ha litefiso tsa laboratori le nako e lekantsoeng ea ho etsa liteko le ho tlaleha liphetho.Nako e phahameng ea nako ke matsatsi a 30.
Tlhokomelo ea lisebelisoa tsa lefa
Ka letsatsi le leng kamora ho lokolla tokomane ea sehlopha sa D IVD, MDCG e phatlalalitse tataiso mabapi le ho lebela lisebelisoa tsa lefa tse lumelletsoeng ho lula 'marakeng oa EU ho fihlela Mots'eanong 2024 ka litifikeiti tse sebetsang tse fanoeng tlasa Active Implantable Medical Devices Directive (AIMDD) kapa Medical Devices Directive (MDD) .
Tataiso e sebetsana le potso e hlahisitsoeng ke Molao oa Sesebediswa sa Bongaka (MDR).Tlas'a MDR, lisebelisoa tsa lefa li ka lula 'marakeng oa EU ho fihlela 2024 haeba li latela litaelo tsa khale' me li sa etse liphetoho tse kholo.Leha ho le joalo, MDR e boetse e hloka lisebelisoa tsa lefa ho fihlela litlhoko tsa molao mabapi le ho lebela ka mor'a 'maraka, ho lebela' maraka, ho falimeha le ho ngolisa basebetsi ba moruo.Ho latela seo, mekhatlo e tsebisitsoeng e lokela ho sebetsa joang ho beha leihlo litsamaiso tsa taolo ea boleng bakeng sa lisebelisoa tsa khale?
Tataiso ea MDCG e araba potso eo, e laela mekhatlo e tsebisitsoeng hore e nke tlaleho ea litlhoko tse ncha moralong oa mesebetsi ea bona ea ho beha leihlo.Ha e le hantle, seo se bolela hore MDCG e batla hore mekhatlo e tsebisitsoeng e hlahlobe litokomane tsa tsamaiso ea boleng, ho hlahloba hore na moetsi o entse liphetoho ho latela MDR, ebe o sebelisa sephetho sa tlhahlobo ho fumana lenaneo la ho hlahloba.
Joalo ka ha litlhokahalo tse ling tsa MDR li sebetsa ho lisebelisoa tsa lefa, "mesebetsi ea tlhatlhobo e lokelang ho etsoa ke mekhatlo e tsebisitsoeng e lokela ho ba ntšetso-pele ea mesebetsi ea pele ea ho beha leihlo ho tsepamisitsoe maikutlo lipehelong tse ncha," ho bolela tataiso.Baetsi ba lokela ho etsa hore Periodic Safety Update Reports le Post Market Surveillance meralo le litlaleho li fumanehe ho mekhatlo ea bona e tsebisitsoeng e le hore ba ka "netefatsa hore tsamaiso ea boleng e fetotsoe ka nepo 'me e lula e lumellana le setifikeiti se fanoeng tlas'a MDD kapa AIMDD. ”
Litataiso tse ling li hlalosa maemo ao mekhatlo e tsebisitsoeng e ka kopanang le eona ho latela hore na baetsi ba ts'ebetso ea MDR ba hokae.Keletso ea MDCG mabapi le mokhoa oa ho atamela leihlo e fapana ho latela hore na, mohlala, moetsi o tla tlosa sesebelisoa sa hae 'marakeng ka 2024 kapa o se a ntse a tiisitsoe ke mokhatlo o mong o tsebisitsoeng tlas'a MDR.
Nako ea poso: Mar-11-2022