{"id":3287,"date":"2021-07-12T20:25:32","date_gmt":"2021-07-12T19:25:32","guid":{"rendered":"https:\/\/www.sskb.sk\/2022\/?p=3287"},"modified":"2021-07-22T11:15:00","modified_gmt":"2021-07-22T10:15:00","slug":"aktuality-z-medzinarodnych-federacii-klinickej-biochemie-a-laboratornej-mediciny-ifcc-a-eflm","status":"publish","type":"post","link":"https:\/\/www.sskb.sk\/2022\/aktuality-z-medzinarodnych-federacii-klinickej-biochemie-a-laboratornej-mediciny-ifcc-a-eflm\/","title":{"rendered":"Aktuality z medzin\u00e1rodn\u00fdch feder\u00e1ci\u00ed klinickej bioch\u00e9mie a laborat\u00f3rnej medic\u00edny (IFCC a EFLM)"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">22.7.2021<\/h2>\n\n\n\n<p><span style=\"color:#041c69\" class=\"has-inline-color\"><strong>Odpove\u010f Ministerstva zdravorn\u00edctva SR na v\u00fdzvu \u010dasov\u00e9ho odkladu implement\u00e1cie nariadenia (E\u00da) 207\/746 o diagnostick\u00fdch zdravotn\u00edckych pom\u00f4ckach in vitro a o zru\u0161en\u00ed smernice 98\/79\/ES a rozhodnutia Komisie 2010\/227\/E\u00da si m\u00f4\u017eete pre\u010d\u00edta\u0165 <\/strong><\/span><strong><span style=\"color:#083ff3\" class=\"has-inline-color\"><a rel=\"noreferrer noopener\" href=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/List-uradny-Sekcia-Balla-Jan-Ing.pdf\" target=\"_blank\">TU<\/a><\/span><\/strong><span style=\"color:#041c69\" class=\"has-inline-color\">.\u00a0<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">12.7.2021<br><span style=\"color:#041c69\" class=\"has-inline-color\">Nadch\u00e1dzaj\u00face svetov\u00e9 a region\u00e1lne kongresy<\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"http:\/\/www.euromedlab2021munich.org\/\"><img decoding=\"async\" width=\"208\" height=\"140\" src=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/logo_munich_red.png\" alt=\"\" class=\"wp-image-3298\" \/><\/a><figcaption><strong>28.november &#8211; 2. december 2021<\/strong><\/figcaption><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><a href=\"http:\/\/www.seoul2022.org\/home\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/logo-seoul-2022-1.jpg\" alt=\"\" class=\"wp-image-3302\" width=\"228\" height=\"266\" srcset=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/logo-seoul-2022-1.jpg 804w, https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/logo-seoul-2022-1-257x300.jpg 257w, https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/logo-seoul-2022-1-768x897.jpg 768w\" sizes=\"(max-width: 228px) 100vw, 228px\" \/><\/a><figcaption><strong>26. &#8211; 30. j\u00fan 2021<\/strong><\/figcaption><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"http:\/\/www.2023roma.org\/\"><img decoding=\"async\" width=\"169\" height=\"140\" src=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/logoromareduced.jpg\" alt=\"\" class=\"wp-image-3300\" \/><\/a><figcaption><strong>21. &#8211; 25. m\u00e1j 2023<\/strong><\/figcaption><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>7.7.2021  <\/strong><br><strong><span style=\"color:#041c69\" class=\"has-inline-color\">IFCC Handbook 2021 &#8211; 2023<\/span><\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"242\" height=\"337\" src=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/cover.png\" alt=\"\" class=\"wp-image-3284\" srcset=\"https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/cover.png 242w, https:\/\/www.sskb.sk\/2022\/wp-content\/uploads\/2021\/07\/cover-215x300.png 215w\" sizes=\"(max-width: 242px) 100vw, 242px\" \/><\/figure>\n\n\n\n<p>Medzin\u00e1rodn\u00e1 feder\u00e1cia klinickej ch\u00e9mie a laborat\u00f3rnej medic\u00edny (IFCC) je celosvetov\u00e1 nepolitick\u00e1 organiz\u00e1cia pre klinick\u00fa ch\u00e9miu a laborat\u00f3rnu medic\u00ednu. <\/p>\n\n\n\n<p>Ako tak\u00e1 m\u00e1 cel\u00fd rad \u00faloh, ktor\u00e9 zah\u0155\u0148aj\u00fa <\/p>\n\n\n\n<p>(1) v spolupr\u00e1ci s in\u00fdmi medzin\u00e1rodn\u00fdmi organiz\u00e1ciami nastavuje glob\u00e1lne \u0161tandardy, <br>(2) podporuje svojich \u010dlenov prostredn\u00edctvom vedeck\u00fdch a vzdel\u00e1vac\u00edch aktiv\u00edt, a <br>(3) organizuje s\u00e9riu kongresov, konferenci\u00ed a m\u00edtingy pre \u0161pecialistov na laborat\u00f3rnu medic\u00ednu, kde sa stret\u00e1vaj\u00fa a predstavuj\u00fa origin\u00e1lne zistenia, poznatky a overen\u00e9 postupy. <\/p>\n\n\n\n<p>IFCC sa do ve\u013ekej miery spolieha na dobrovo\u013en\u00edkov, ktor\u00ed ved\u00fa organiz\u00e1ciu a uskuto\u010d\u0148uj\u00fa cel\u00fd rad jej aktiv\u00edt a programov. T\u00edto dobrovo\u013en\u00edci sa neust\u00e1le menia, a preto je potrebn\u00fd referen\u010dn\u00fd dokument, ktor\u00fd m\u00e1 pom\u00f4c\u0165 \u013eu\u010fom, ktor\u00ed sa chc\u00fa dozvedie\u0165 viac inform\u00e1ci\u00ed o IFCC a jej fungovan\u00ed. T\u00fdmto referen\u010dn\u00fdm dokumentom je t\u00e1to<strong> <a href=\"https:\/\/www.ifcc.org\/media\/479067\/ifcc-handbook-2021-2023.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">pr\u00edru\u010dka IFCC<\/a><\/strong>. <\/p>\n\n\n\n<p>Pr\u00edru\u010dka IFCC sa vyd\u00e1va raz za tri roky, aby sa kryla s obdob\u00edm p\u00f4sobenia ka\u017edej v\u00fdkonnej rady. IFCC je v\u0161ak dynamick\u00e1 organiz\u00e1cia, ktor\u00e1 sa neust\u00e1le vyv\u00edja. Najaktu\u00e1lnej\u0161ie inform\u00e1cie o IFCC s\u00fa v\u017edy k dispoz\u00edcii na webov\u00fdch str\u00e1nkach IFCC (www.ifcc.org).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>23.6.2021 <\/strong><br><strong><span class=\"has-inline-color has-vivid-purple-color\">Strategick\u00e1 konferencia EFLM 2022<\/span><\/strong><\/h3>\n\n\n\n<p>Profesorka Tomris Ozbenov\u00e1, novozvolen\u00e1 prezidentka EFLM na roky 2022-2023, predlo\u017eila predbe\u017en\u00fd n\u00e1vrh na konanie Strategickej konferencie EFLM 2022.  Informuje v \u0148om, \u017ee s\u00e9ria strategick\u00fdch konferenci\u00ed EFLM sa zameriava na rie\u0161enie a diskusiu o najnov\u0161om v\u00fdvoji a v\u00fdzvach v laborat\u00f3rnej medic\u00edne. Z\u00e1kladn\u00fd cie\u013e je zameran\u00fd na d\u00f4le\u017eit\u00e9 aspekty laborat\u00f3rnej medic\u00edny, v ktorej by sa mali prija\u0165 niektor\u00e9 strategick\u00e9 opatrenia. Pod\u013ea Stanov EFLM sa pr\u00edprava strategickej konferencie EFLM za\u010d\u00edna pod koordin\u00e1ciou nozvolen\u00e9ho prezidenta. &#8222;<em>T<span style=\"color:#024c6c\" class=\"has-inline-color\">oto je t\u00edmov\u00e1 pr\u00e1ca a bude pre m\u0148a ve\u013ek\u00fdm pote\u0161en\u00edm<\/span><\/em>,&#8220; p\u00ed\u0161e vo svojom liste prof. Tomris Ozbenov\u00e1, &#8222;<em><span style=\"color:#025172\" class=\"has-inline-color\">\u00fazko s vami spolupracova\u0165 pri pl\u00e1novan\u00ed strategickej konferencie. Ver\u00edm, \u017ee konzult\u00e1cie a spolupr\u00e1ca, \u00fa\u010das\u0165 na v\u00fdbere a spolu\u00fa\u010das\u0165 na navrhovan\u00fdch pokrokoch s\u00fa \u017eivotne d\u00f4le\u017eit\u00fdmi k\u013e\u00fa\u010dmi pre dosiahnutie bud\u00faceho \u00faspechu a splnenie in\u0161titucion\u00e1lnych cie\u013eov a zdrav\u00e9ho v\u00fdvoja. V s\u00fa\u010dasnosti je \u0165a\u017ek\u00e9 rozhodn\u00fa\u0165 o form\u00e1te (online a \/ alebo konanie konferencie s fyzickou \u00fa\u010das\u0165ou), mieste konania a d\u00e1tume konania konferencie, ktor\u00e1 sa m\u00e1 kona\u0165 v roku 2022. Je v\u0161ak nevyhnutn\u00e9 za\u010da\u0165 pracova\u0165 a definova\u0165 strategick\u00e9 t\u00e9my programu konferencie. do konca roku 2021. Predbe\u017en\u00fd n\u00e1zov a obsah strategickej konferencie je uveden\u00fd <a href=\"https:\/\/mail.google.com\/mail\/u\/1?ui=2&amp;ik=bdfbe8b321&amp;attid=0.1&amp;permmsgid=msg-f:1703369245664582420&amp;th=17a3954dd9299b14&amp;view=att&amp;disp=inline\" target=\"_blank\" rel=\"noreferrer noopener\">v pr\u00edlohe<\/a>. Te\u0161\u00edm sa na va\u0161e pripomienky a n\u00e1vrhy na definovanie a stanovenie prior\u00edt strategick\u00fdch cie\u013eov zameran\u00fdch na strategick\u00e9 pl\u00e1ny EFLM, ktor\u00e9 bud\u00fa schv\u00e1len\u00e9 a plne prijat\u00e9 n\u00e1rodn\u00fdmi spolo\u010dnos\u0165ami EFLM. Odpovede pros\u00edm zasielajte na moje osobn\u00fa e-mailov\u00fa adresuy uveden\u00e9 ni\u017e\u0161ie do<strong> 31. j\u00fala 2021.<\/strong><\/span> <\/em>&#8222;<\/p>\n\n\n\n<h6 class=\"wp-block-heading\"><span class=\"has-inline-color has-cyan-bluish-gray-color\">Tomris Ozben<br>EFLM President-Elect<br>Prof. Dr Tomris Ozben, Ph.D., D.Sc., Specialist in Clin. Biochemistry<br>EFLM, Executive Board, President-Elect<br>Akdeniz University<br>Medical Faculty<br>Dept. of Clinical Biochemistry&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br>07070 Antalya Turkey<br>e-mail:&nbsp;<\/span><span style=\"color:#032691\" class=\"has-inline-color\"><a rel=\"noreferrer noopener\" href=\"mailto:ozben@akdeniz.edu.tr\" target=\"_blank\">ozben@akdeniz.edu.tr<\/a>;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<a rel=\"noreferrer noopener\" href=\"mailto:tomris.ozben@unimore.it\" target=\"_blank\">tomris.ozben@unimore.it<\/a><\/span><\/h6>\n\n\n\n<h3 class=\"wp-block-heading\">11. 6. 2021 <br><strong><span style=\"color:#040f8d\" class=\"has-inline-color\">Konajme teraz spolo\u010dne, aby sme sa vyhli zlej implement\u00e1cii IVDR a mo\u017en\u00e9mu kolapsu diagnostick\u00e9ho sektoru<\/span><\/strong><\/h3>\n\n\n\n<p>Poskytovatelia zdravotnej starostlivosti pre laborat\u00f3rnu diagnostiku Biomedical Alliance [1] v&nbsp;Eur\u00f3pe s\u00fa v\u00e1\u017ene znepokojen\u00ed stavom implement\u00e1cie nariadenia o&nbsp;diagnostick\u00fdch pr\u00edpravkoch (laborat\u00f3rnych testov) in vitro (IVDR) a jeho potenci\u00e1lnymi katastrof\u00e1lnymi d\u00f4sledkami pre diagnostick\u00fa prax v E\u00da. Od <strong>26. m\u00e1ja 2022 <\/strong>bud\u00fa musie\u0165 by\u0165 diagnostick\u00e9 testy in vitro v s\u00falade s IVDR, ktorej cie\u013eom je zabezpe\u010di\u0165 klinick\u00fa \u00fa\u010dinnos\u0165 a bezpe\u010dnos\u0165 lek\u00e1rskych testov. To je ve\u013emi v\u00edtan\u00e9, vy\u017eaduje si to v\u0161ak transform\u00e1ciu cel\u00e9ho diagnostick\u00e9ho sektoru vr\u00e1tane v\u00fdznamn\u00fdch zmien v procese posudzovania zhody IVD. Mnoho kritick\u00fdch regula\u010dn\u00fdch prvkov dodnes nie je zaveden\u00fdch a st\u00e1le ch\u00fdba d\u00f4le\u017eit\u00e9 usmernenie, \u010do pre z\u00fa\u010dastnen\u00e9 strany znamen\u00e1 nesmierne n\u00e1ro\u010dn\u00e9 pripravi\u0165 sa na nov\u00e9 regula\u010dn\u00e9 prostredie v plnom rozsahu a t\u00fdm zabezpe\u010di\u0165 kontinuitu diagnostiky po m\u00e1ji 2022.<\/p>\n\n\n\n<p>Ke\u010f\u017ee regula\u010dn\u00e1 infra\u0161trukt\u00fara E\u00da pre certifik\u00e1ciu a umo\u017enenie pr\u00edstupu na trh konven\u010dn\u00fdch medic\u00ednskych laborat\u00f3rnych testov pod\u013ea IVDR nie je zaveden\u00e9, kontinuita a dostupnos\u0165 konven\u010dn\u00fdch medic\u00ednskych testov je ohrozen\u00e1. Do apr\u00edla 2021 z\u00edskalo <strong>CE zna\u010dku<\/strong> pod\u013ea IVDR iba <strong>7 laborat\u00f3rnych testov<\/strong> z&nbsp;cca <strong>19&nbsp;000&nbsp; testov<\/strong>. <strong>Aliancia BioMed<\/strong> (Biomedic\u00ednska aliancia v&nbsp;Eur\u00f3pe), jedine\u010dn\u00e1 iniciat\u00edva 36 popredn\u00fdch <strong>eur\u00f3pskych lek\u00e1rskych spolo\u010dnost\u00ed<\/strong>, ktor\u00e9 zah\u0155\u0148aj\u00fa viac ako 400 000 v\u00fdskumn\u00fdch a zdravotn\u00edckych pracovn\u00edkov, je t\u00fdmto stavom v\u00e1\u017ene znepokojen\u00e1. Riadnym \u010dlenom Eur\u00f3pskej feder\u00e1cie laborat\u00f3rnej medic\u00edny (EFLM), ktor\u00e1 je \u010dlenom Aliancie BioMed, je aj Slovensk\u00e1 spolo\u010dnos\u0165 klinickej bioch\u00e9mie (SSKB).&nbsp; Exekut\u00edva EFLM vyzvala svojich riadnych \u010dlenov (SSKB) pripoji\u0165 sa k&nbsp;vyhl\u00e1seniu, ktor\u00e9 pripravila profesorka Christa Cobbaert, predsedn\u00ed\u010dka pracovnej skupiny EFLM pre eur\u00f3pske regula\u010dn\u00e9 z\u00e1le\u017eitosti.&nbsp; Pracovn\u00e1 skupina EFLM pre eur\u00f3pske regula\u010dn\u00e9 z\u00e1le\u017eitosti vyz\u00fdva n\u00e1rodn\u00fdch z\u00e1stupcov odborn\u00fdch spolo\u010dnost\u00ed laborat\u00f3rnej medic\u00edny v\u0161etk\u00fdch \u010dlensk\u00fdch \u0161t\u00e1tov E\u00da, aby prijali okam\u017eit\u00e9 opatrenia na zabr\u00e1nenie kolapsu diagnostick\u00fdch testov.<\/p>\n\n\n\n<p>Je potrebn\u00e9 podnikn\u00fa\u0165 urgentn\u00e9 kroky, aby sa zabr\u00e1nilo kolapsu laborat\u00f3rneho diagnostick\u00e9ho testovania. Nov\u00e9 <strong>Eur\u00f3pske nariadenie o diagnostik\u00e1ch in vitro (IVDR) EU \/ 2017\/746 <\/strong>[2], uverejnen\u00e9 v \u00daradnom vestn\u00edku Eur\u00f3pskej \u00fanie 5. m\u00e1ja 2017, nadobudlo \u00fa\u010dinnos\u0165 25. m\u00e1ja 2017. Ofici\u00e1lne prechodn\u00e9 obdobie na \u00fapln\u00fa implement\u00e1ciu je p\u00e4\u0165 rokov. Najv\u00e4\u010d\u0161\u00edmi zmenami bez ochrany predch\u00e1dzaj\u00faceho stavu s\u00fa roz\u0161\u00edrenie rozsahu p\u00f4sobnosti a zavedenie pr\u00edstupu ku klasifik\u00e1cii zalo\u017een\u00e9ho na riziku v kombin\u00e1cii so zv\u00fd\u0161en\u00fdm doh\u013eadom notifikovan\u00e9ho org\u00e1nu (NB). IVD spolo\u010dnosti (diagnostick\u00e9 firmy) musia do konca p\u00e4\u0165ro\u010dn\u00e9ho prechodn\u00e9ho obdobia preregistrova\u0165 <strong>cel\u00e9 svoje portf\u00f3lio IVD<\/strong> pod\u013ea nov\u00e9ho nariadenia. Implement\u00e1cia IVDR sa pl\u00e1nuje vo v\u0161etk\u00fdch \u010dlensk\u00fdch \u0161t\u00e1toch E\u00da <strong>do 26. m\u00e1ja 2022<\/strong>. V s\u00fa\u010dasnosti sa za\u010dalo jednoro\u010dn\u00e9 odpo\u010d\u00edtavanie do d\u00e1tumu \u017eiadosti IVDR.<\/p>\n\n\n\n<p>V roku 2017 boli prijat\u00e9 dve nov\u00e9 nariadenia, ktor\u00e9 bli\u017e\u0161ie upravuj\u00fa fungovanie zdravotn\u00edckych pom\u00f4cok (pr\u00edpravkov). Ide o Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) IVDR 2017\/746 o diagnostick\u00fdch zdravotn\u00edckych pom\u00f4ckach in vitro [2] a Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2017\/745 o zdravotn\u00edckych pom\u00f4ckach (MDR) [3]. S\u00fa\u010dasne do\u0161lo k zru\u0161eniu doteraj\u0161\u00edch smern\u00edc o zdravotn\u00edckych pom\u00f4ckach (Smernice \u010d. 93\/42\/EEC, Smernice \u010d. 98\/79\/EC a Smernice \u010d. 90\/385\/EEC). Po\u010das pand\u00e9mie COVID Eur\u00f3pska komisia, notifikovan\u00e9 org\u00e1ny a v\u00fdrobcovia IVD vlo\u017eili v\u00e4\u010d\u0161inu svojich zdrojov a&nbsp;\u00fasilia do v\u00fdvoja a certifik\u00e1cie (vlastn\u00fdch) testov COVID. Z&nbsp;tohto d\u00f4vodu sa \u00fa\u010dinnos\u0165 z\u00e1kona o&nbsp;implement\u00e1cii smernice MDR, ktor\u00e1 u\u017e mala aj dos\u0165 vyspel\u00fd regula\u010dn\u00fd syst\u00e9m, sa odlo\u017eila o jeden rok. a v plnom rozsahu sa za\u010dala pou\u017e\u00edva\u0165 od 25. m\u00e1ja 2021. To do istej miery objas\u0148uje neprijate\u013enos\u0165 regula\u010dn\u00e9ho syst\u00e9mu E\u00da pre certifik\u00e1ciu medic\u00ednskych testov.<\/p>\n\n\n\n<p>N\u00e1rodn\u00fdch predstavite\u013eov kraj\u00edn E\u00da preto \u017eiadame, aby sa v&nbsp;najbli\u017e\u0161\u00edch d\u0148och obr\u00e1tili na svojich n\u00e1rodn\u00fdch ministrov zdravotn\u00edctva a aby ich informovali o zlo\u017eitej situ\u00e1cii, ktorej bud\u00fa laborat\u00f3rni odborn\u00edci, lek\u00e1ri a pacienti \u010deli\u0165 do m\u00e1ja 2022, ak sa ni\u010d neudeje. N\u00e1rodn\u00ed z\u00e1stupcovia by mali po\u017eiada\u0165 svojich ministrov zdravotn\u00edctva, aby sa vyjadrili po\u010das nasleduj\u00faceho j\u00fanov\u00e9ho zasadnutia EPSCO 14.- 15. j\u00fana 2021. Toto stretnutie organizuje Rada Eur\u00f3pskej \u00fanie a zameriava sa na zamestnanos\u0165, soci\u00e1lnu politiku, zdravie a ochranu spotrebite\u013ea. Domnievame sa, \u017ee <strong>nariadenie o IVD bude na programe d\u0148a<\/strong>. Ak niektor\u00ed ministri zdravotn\u00edctva pripomen\u00fa naliehav\u00fa potrebu rie\u0161i\u0165 v\u00fdzvy IVDR na j\u00fanovom zasadnut\u00ed EPSCO, d\u00fafame, \u017ee by to vyvolalo skuto\u010dn\u00fa diskusiu na politickej \u00farovni, ktor\u00e1 povedie k rie\u0161eniam. Diskusia na stretnut\u00ed EPSCO viedla aj k rie\u0161eniam syst\u00e9mu MDR (pred\u013a\u017eila sa ochrann\u00e1 lehota a potom sa dohodol 1-ro\u010dn\u00fd odklad). Preto je <strong>EPSCO m\u00edting 14. &#8211; 15. j\u00fana 2021<\/strong> d\u00f4le\u017eitou \u0161ancou, aby sa nariadenie o IVD stalo prioritou pre \u010dlensk\u00e9 \u0161t\u00e1ty E\u00da. \u010c\u00edm viac ministrov zdravotn\u00edctva prehovor\u00ed, t\u00fdm je pravdepodobnej\u0161ie, \u017ee bud\u00fa k dispoz\u00edcii v\u010dasn\u00e9 rie\u0161enia pre nariadenie o IVD!<\/p>\n\n\n\n<p>Preto\u017ee s postupuj\u00facimi o\u010dkovac\u00edmi kampa\u0148ami proti COVID sa na konci tunela objavuje svetlo a ke\u010f\u017ee MDR sa za\u010dalo implementova\u0165 v m\u00e1ji 2021 (namiesto p\u00f4vodn\u00e9ho term\u00ednu v&nbsp;m\u00e1ji 2020), teraz by sa mala venova\u0165 pozornos\u0165 spr\u00e1vnej implement\u00e1cii IVDR. Politici E\u00da by preto pod\u013ea nej mali n\u00e1js\u0165 rie\u0161enie na zodpovedn\u00fa a bezpe\u010dn\u00fa implement\u00e1ciu p\u00f4vodn\u00fdch cie\u013eov IVDR, t. j. na bezpe\u010dn\u00fa a efekt\u00edvnu diagnostiku a&nbsp;zdravotn\u00fa starostlivos\u0165 o pacientov v celej Eur\u00f3pe.<\/p>\n\n\n\n<p>V mene V\u00fdboru Slovenskej spolo\u010dnosti klinickej bioch\u00e9mie v\u00e1m odovzd\u00e1vame prilo\u017een\u00e9 vyhl\u00e1senie EB&nbsp; EFLM \u201e<em>Implement\u00e1cia nov\u00e9ho nariadenia E\u00da pre diagnostick\u00e9 zdravotn\u00edcke pr\u00edpravky &nbsp;in vitro: tikaj\u00faca \u010dasovan\u00e1 bomba pre diagnostick\u00fd sektor<\/em>\u201c a&nbsp;sumariza\u010dn\u00fa tabu\u013eku \u201e<em>Nes\u00falad medzi regula\u010dn\u00fdmi ustanoveniami E\u00da a klinickou potrebou zdravotn\u00edckych pom\u00f4cok s&nbsp;IVD\u201c.<\/em><\/p>\n\n\n\n<p>\u010ealej uv\u00e1dzame nieko\u013eko inform\u00e1ci\u00ed o aktu\u00e1lnej situ\u00e1cii a jej po\u017eiadavke, aby ste s akciou s\u00fahlasili. Nov\u00e9 eur\u00f3pske nariadenie o diagnostike in vitro (IVDR) EU \/ 2017\/746, uverejnen\u00e9 v \u00daradnom vestn\u00edku Eur\u00f3pskej \u00fanie 5. m\u00e1ja 2017, nadobudlo platnos\u0165 25. m\u00e1ja 2017. Ofici\u00e1lne prechodn\u00e9 obdobie na \u00fapln\u00fa implement\u00e1ciu je <strong>p\u00e4\u0165 rokov<\/strong>.&nbsp; Najv\u00e4\u010d\u0161\u00edmi zmenami s\u00fa roz\u0161\u00edrenie rozsahu p\u00f4sobnosti a zavedenie pr\u00edstupu ku klasifik\u00e1cii zalo\u017een\u00e9ho na riziku v kombin\u00e1cii so zv\u00fd\u0161en\u00fdm doh\u013eadom notifikovan\u00e9ho org\u00e1nu (NB), bez ochrany predch\u00e1dzaj\u00faceho stavu. Spolo\u010dnosti IVD musia do konca p\u00e4\u0165ro\u010dn\u00e9ho prechodn\u00e9ho obdobia preregistrova\u0165 cel\u00e9 svoje portf\u00f3lio IVD pod\u013ea nov\u00e9ho nariadenia. Implement\u00e1cia IVDR sa pl\u00e1nuje vo v\u0161etk\u00fdch \u010dlensk\u00fdch \u0161t\u00e1toch E\u00da do m\u00e1ja 2022. V s\u00fa\u010dasnosti sa za\u010dalo jednoro\u010dn\u00e9 odpo\u010d\u00edtavanie do IVDR D\u00e1tumu \u017eiadosti. Preto\u017ee v\u0161ak regula\u010dn\u00e1 infra\u0161trukt\u00fara E\u00da pre certifik\u00e1ciu a umo\u017enenie pr\u00edstupu na trh konven\u010dn\u00fdch lek\u00e1rskych testov pod\u013ea IVDR nie je zaveden\u00e1, kontinuita a dostupnos\u0165 konven\u010dn\u00fdch lek\u00e1rskych testov je ohrozen\u00e1. Do apr\u00edla 2021 z\u00edskalo pod\u013ea IVDR iba 7 lek\u00e1rskych testov z ~ 19 000 testov CE. Aliancia BioMed, ktorej \u010dlenom je EFLM, a pracovn\u00e1 skupina EFLM pre eur\u00f3pske regula\u010dn\u00e9 z\u00e1le\u017eitosti vyz\u00fdvaj\u00fa n\u00e1rodn\u00fdch z\u00e1stupcov vedeck\u00fdch spolo\u010dnost\u00ed laborat\u00f3rnej medic\u00edny v\u0161etk\u00fdch \u010dlensk\u00fdch \u0161t\u00e1tov E\u00da, aby prijali okam\u017eit\u00e9 opatrenia na zabr\u00e1nenie kolapsu diagnostick\u00fdch testov. \u201c Prilo\u017een\u00e9 vyhl\u00e1senie s n\u00e1zvom: \u201eImplement\u00e1cia nov\u00e9ho nariadenia E\u00da pre diagnostick\u00e9 zdravotn\u00edcke pr\u00edstroje in vitro: tikaj\u00faca \u010dasovan\u00e1 bomba pre diagnostick\u00fd sektor\u201c a tabu\u013eka objas\u0148uj\u00fa tvrd\u00fa zast\u00e1vku, ktorej bude diagnostick\u00fd sektor \u010deli\u0165 pri be\u017en\u00fdch CE-IVD, ak to neurob\u00edme spolo\u010dne postav sa teraz. N\u00e1rodn\u00fdch predstavite\u013eov kraj\u00edn E\u00da preto \u017eiadame, aby sa v najbli\u017e\u0161\u00edch t\u00fd\u017ed\u0148och \/ do konca m\u00e1ja obr\u00e1tili na svojich n\u00e1rodn\u00fdch ministrov zdravotn\u00edctva, aby ich informovali o zlo\u017eitej situ\u00e1cii, ktorej bud\u00fa laborat\u00f3rni odborn\u00edci, opatrovatelia a pacienti \u010deli\u0165 do m\u00e1ja 2022, ak sa ni\u010d nestane. N\u00e1rodn\u00ed z\u00e1stupcovia by mali po\u017eiada\u0165 svojich ministrov zdravotn\u00edctva, aby sa vyjadrili po\u010das nasleduj\u00faceho j\u00fanov\u00e9ho zasadnutia EPSCO: zasadania EPSCO 14. &#8211; 15. j\u00fana. Toto stretnutie organizuje Rada Eur\u00f3pskej \u00fanie a zameriava sa na zamestnanos\u0165, soci\u00e1lnu politiku, zdravie a ochranu spotrebite\u013ea. Ch\u00e1peme, \u017ee nariadenie o IVD bude na programe d\u0148a. Ak niektor\u00ed ministri zdravotn\u00edctva hovoria o naliehavej potrebe vyrie\u0161i\u0165 v\u00fdzvy IVDR na j\u00fanovom zasadan\u00ed EPSCO, d\u00fafame, \u017ee by to vyvolalo skuto\u010dn\u00fa diskusiu na politickej \u00farovni a povedie k rie\u0161eniam. Diskusia na stretnut\u00ed EPSCO viedla aj k rie\u0161eniam syst\u00e9mu MDR (pred\u013a\u017eila sa ochrann\u00e1 lehota a potom sa dohodol 1-ro\u010dn\u00fd odklad). Stretnutie EPSCO, ktor\u00e9 sa uskuto\u010dn\u00ed 14. &#8211; 15. j\u00fana 2021, je preto d\u00f4le\u017eitou pr\u00edle\u017eitos\u0165ou na to, aby sa nariadenie o IVD stalo prioritou pre \u010dlensk\u00e9 \u0161t\u00e1ty. \u010c\u00edm viac ministrov zdravotn\u00edctva prehovor\u00ed, t\u00fdm je pravdepodobnej\u0161ie, \u017ee bud\u00fa k dispoz\u00edcii v\u010dasn\u00e9 rie\u0161enia pre nariadenie o IVD! Na z\u00e1ver: od pand\u00e9mie COVID, v\u00e4\u010d\u0161ina zdrojov a \u00fasilia Eur\u00f3pskej komisie, notifikovan\u00fdch org\u00e1nov a v\u00fdrobcov IVD \u0161la do v\u00fdvoja a certifik\u00e1cie (samo) testov COVID. To do istej miery objas\u0148uje neprijate\u013enos\u0165 regula\u010dn\u00e9ho syst\u00e9mu E\u00da pre certifik\u00e1ciu lek\u00e1rskych testov. Kv\u00f4li pand\u00e9mii COVID sa implement\u00e1cia MDR, ktor\u00e1 u\u017e mala dos\u0165 vyspel\u00fd regula\u010dn\u00fd syst\u00e9m, musela odlo\u017ei\u0165 o jeden rok. Preto\u017ee v tuneli teraz svieti svetlo s postupuj\u00facimi vakcina\u010dn\u00fdmi kampa\u0148ami proti COVID a ke\u010f\u017ee MDR sa bude vykon\u00e1va\u0165 v m\u00e1ji 2021, mala by sa teraz venova\u0165 pozornos\u0165 riadnej implement\u00e1cii IVDR. Politici E\u00da by preto mali n\u00e1js\u0165 rie\u0161enie na zodpovedn\u00e9 a bezpe\u010dn\u00e9 vykon\u00e1vanie IVDR v s\u00falade s p\u00f4vodn\u00fdmi cie\u013emi, t. J. Na bezpe\u010dn\u00fa a efekt\u00edvnu diagnostiku pacientov a starostlivos\u0165 o pacientov v celej Eur\u00f3pe. N\u00e1rodn\u00ed z\u00e1stupcovia a \u010dlenovia spolo\u010dnost\u00ed laborat\u00f3rnej medic\u00edny: ako v\u00fdkonn\u00e1 rada EFLM sa spoliehame na v\u00e1s a va\u0161e urgentn\u00e9 kroky!<\/p>\n\n\n\n<ol class=\"wp-block-list\" type=\"1\"><li>https:\/\/www.biomedeurope.org\/<\/li><li>Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC<\/li><li>Regulation (Eu) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on <em>in vitro <\/em>diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU<\/li><\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">11.6.2021 <br><strong><span style=\"color:#040f8d\" class=\"has-inline-color\">Implement\u00e1cia nov\u00e9ho nariadenia E\u00da pre diagnostick\u00e9 zdravotn\u00edcke pr\u00edstroje in vitro: tikaj\u00faca \u010dasovan\u00e1 bomba pre diagnostick\u00fd sektor<\/span><\/strong><\/h3>\n\n\n\n<p>Po\u010das workshopu \u201ePotreba lep\u0161\u00edch polit\u00edk E\u00da v oblasti zdravia\u201c, ktor\u00fd organizoval Panel pre bud\u00facnos\u0165 vedy a techniky (STOA) Eur\u00f3pskeho parlamentu, z\u00e1stupcovia IVD pracovnej skupiny Aliancie BioMed zd\u00f4raznili, \u017ee bez kritickej infra\u0161trukt\u00fary, usmer\u0148ovac\u00edch dokumentov a&nbsp;alternat\u00edvnych pl\u00e1nov pre v\u0161etky pr\u00edpady d\u00f4jde k naru\u0161eniu dostupnosti z\u00e1kladn\u00fdch diagnostick\u00fdch testov (IVD so zna\u010dkou CE). Je potrebn\u00fd jasn\u00fd a vhodn\u00fd n\u00e1vod pre dom\u00e1ce testy ( \u201ein-house devices\u201c ), zn\u00e1me ako laborat\u00f3rne testy vyvinut\u00e9 v laborat\u00f3riu (LDT), s cie\u013eom pom\u00f4c\u0165 laborat\u00f3ri\u00e1m sa v\u010das pripravi\u0165 na nov\u00fa legislat\u00edvu a podpori\u0165 v\u00fdvoj inovat\u00edvnych rie\u0161en\u00ed pre \u0161peci\u00e1lne aplik\u00e1cie, zriedkav\u00e9 choroby a r\u00fdchle reakcie na zdravotn\u00e9 kr\u00edzy.<\/p>\n\n\n\n<p>Diagnostick\u00e9 odvetvie bude nov\u00fdm nariaden\u00edm transformovan\u00e9 a je na tvorcoch polit\u00edk a v\u0161etk\u00fdch zainteresovan\u00fdch stran\u00e1ch, aby sa vyhli rizik\u00e1m nespr\u00e1vnej implement\u00e1cie IVDR. S\u00fa\u010dasn\u00fd stav implement\u00e1cie IVDR (nedostato\u010dn\u00fd po\u010det notifikovan\u00fdch org\u00e1nov, nedostupnos\u0165 datab\u00e1zy EUDAMED, panely odborn\u00edkov a \/ alebo referen\u010dn\u00e9 laborat\u00f3ri\u00e1, ktor\u00e9 e\u0161te nie s\u00fa funk\u010dne pripraven\u00e9 na vyhodnocovanie testov s najvy\u0161\u0161\u00edm rizikom, nedostatok pohotovostn\u00fdch pl\u00e1nov, oneskoren\u00e9 usmernenie) hroz\u00ed naru\u0161en\u00edm eur\u00f3pskeho diagnostick\u00e9ho sektoru a v\u00e1\u017ene ovplyv\u0148uj\u00fa \u017eivoty pacientov v celej Eur\u00f3pe.<\/p>\n\n\n\n<p>Hlavn\u00e9 d\u00f4sledky bud\u00fa:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>z\u00e1kladn\u00e9 testy ozna\u010den\u00e9 CE nebud\u00fa na eur\u00f3pskom trhu k dispoz\u00edcii alebo zmizn\u00fa<\/li><li>\u0161peci\u00e1lne testy ozna\u010den\u00e9 CE (pre genetiku, virol\u00f3giu, molekul\u00e1rnu diagnostiku, rakovinu) bud\u00fa obzvl\u00e1\u0161\u0165 zranite\u013en\u00e9<\/li><li>personalizovan\u00e1 diagnostika a testy na zriedkav\u00e9 choroby sa nebud\u00fa rozv\u00edja\u0165 a tendencia k monopolom v testoch ozna\u010den\u00fdch CE obmedz\u00ed ich diagnostick\u00fd rozsah<\/li><li>bude brzden\u00fd v\u00fdvoj nov\u00fdch a kreat\u00edvnych rie\u0161en\u00ed pre zriedkav\u00e9 choroby a zdravotn\u00e9 kr\u00edzy, ako je napr. &nbsp;Covid-19<\/li><li>diagnostick\u00e9 laborat\u00f3ri\u00e1 nebud\u00fa schopn\u00e9 nies\u0165 bremeno splnenia po\u017eiadaviek na v\u0161etky svoje vlastn\u00e9 IVD zariadenia \/ LDT, tak\u017ee m\u00f4\u017eu opusti\u0165 \u010das\u0165 svojho s\u00fa\u010dasn\u00e9ho testovacieho portf\u00f3lia<\/li><\/ul>\n\n\n\n<p>Preto vyz\u00fdvame Eur\u00f3psku komisiu a v\u0161etky \u010dlensk\u00e9 \u0161t\u00e1ty, aby sa bezodkladne zaoberali t\u00fdmito probl\u00e9mami IVDR:<\/p>\n\n\n\n<ol class=\"wp-block-list\" type=\"1\"><li><strong>Nedostatok notifikovan\u00fdch org\u00e1nov.<\/strong><\/li><\/ol>\n\n\n\n<p><strong>Nedostatok kapacity notifikovan\u00e9ho org\u00e1nu ovplyvn\u00ed dostupnos\u0165 zariaden\u00ed IVD so zna\u010dkou CE. Asi 70% rozhodnut\u00ed lek\u00e1rov sa zaklad\u00e1 na v\u00fdsledkoch diagnostick\u00fdch testov, \u010do v\u00e1\u017ene obmedz\u00ed starostlivos\u0165 o pacientov.<\/strong><\/p>\n\n\n\n<p>S\u00fa\u010dasn\u00e1 situ\u00e1cia: Pod\u013ea IVDR boli v s\u00fa\u010dasnosti ur\u010den\u00e9 iba 4 notifikovan\u00e9 org\u00e1ny. 90% IVD v porovnan\u00ed s 10% pod\u013ea predch\u00e1dzaj\u00facej smernice 98\/79 \/ ES2. bude musie\u0165 podst\u00fapi\u0165 pos\u00fadenie zhody notifikovan\u00fdm org\u00e1nom. Situ\u00e1cia je alarmuj\u00faca, ak vezmeme do \u00favahy, \u017ee doteraz iba 7 testov z cca. 19 000 testov bolo certifikovan\u00fdch pod\u013ea IVDR a v s\u00fa\u010dasnosti sa posudzuje iba \u010fal\u0161\u00edch 249 testov. Spracovanie \u017eiadosti o certifik\u00e1t notifikovan\u00e9ho org\u00e1nu trv\u00e1 v priemere 10 mesiacov a 78% v\u00fdrobcov IVD nahl\u00e1silo probl\u00e9my s certifika\u010dn\u00fdm procesom IVD. Prek\u00e1\u017eky v pr\u00edstupe k notifikovan\u00e9mu org\u00e1nu spolu s nemo\u017enos\u0165ou dlhodob\u00e9ho predv\u00eddania n\u00fatia v\u00fdrobcov, najm\u00e4 mal\u00e9 a stredn\u00e9 podniky, aby zastavili v\u00fdrobu cel\u00e9ho radu CE-IVD. To sp\u00f4sob\u00ed \u0165a\u017ekosti poskytovate\u013eom diagnostiky zdravotnej starostlivosti, ktor\u00ed sa pri poskytovan\u00ed rie\u0161en\u00ed zdravotnej starostlivosti pacientom spoliehaj\u00fa na testy ozna\u010den\u00e9 zna\u010dkou CE.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Obrovsk\u00e1 neistota okolo pou\u017e\u00edvania dom\u00e1cich laborat\u00f3rnych testov (LDT).<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Nedostatok vhodn\u00fdch pokynov pre klinick\u00e9 laborat\u00f3ri\u00e1 s\u0165a\u017euje ich pr\u00edpravu na IVDR. Interpret\u00e1cia po\u017eiadaviek IVDR na LDT by mohla br\u00e1ni\u0165 ich dostupnosti a v\u00fdvoju novej diagnostiky a testov na zriedkav\u00e9 choroby.<\/strong><\/p>\n\n\n\n<p>S\u00fa\u010dasn\u00e1 situ\u00e1cia: Diagnostick\u00e9 testy vyvinut\u00e9 v&nbsp;laborat\u00f3ri\u00e1ch maj\u00fa z\u00e1sadn\u00fa \u00falohu v diagnostike v celej Eur\u00f3pe. Ned\u00e1vna pr\u00edpadov\u00e1 \u0161t\u00fadia vo ve\u013ekom laborat\u00f3riu univerzitnej nemocnice v Belgicku uk\u00e1zala, \u017ee 47% testov realizovan\u00fdch v nemocni\u010dn\u00fdch laborat\u00f3ri\u00e1ch s\u00fa LDT. V \u0161pecializovan\u00fdch laborat\u00f3ri\u00e1ch sa tento po\u010det m\u00f4\u017ee zv\u00fd\u0161i\u0165 a\u017e na 80 &#8211; 90%. \u010casto ide o komplexn\u00e9 testy na zriedkav\u00e9 choroby a \/ alebo testy, ktor\u00e9 sa vykon\u00e1vaj\u00fa zriedka. LDT vyp\u013a\u0148aj\u00fa medzeru poskytovan\u00edm r\u00fdchlo implementovate\u013en\u00fdch a personalizovan\u00fdch rie\u0161en\u00ed, ke\u010f alternat\u00edvy so zna\u010dkou CE nie s\u00fa na trhu k dispoz\u00edcii (vy\u0161\u0161ie uveden\u00e1 pr\u00edpadov\u00e1 \u0161t\u00fadia zistila, \u017ee v s\u00fa\u010dasnosti nie je k dispoz\u00edcii alternat\u00edva pre 72% LDT). Napr\u00edklad LDT hrali z\u00e1sadn\u00fa \u00falohu pri poskytovan\u00ed r\u00fdchlych rie\u0161en\u00ed v ran\u00fdch f\u00e1zach pand\u00e9mie COVID-19. LDT bud\u00fa povolen\u00e9 pod\u013ea IVDR za pr\u00edsnych podmienok (\u017eiadna alternat\u00edva s ozna\u010den\u00edm CE, opr\u00e1vnen\u00e9 pou\u017eitie, kvalita je zabezpe\u010den\u00e1 splnen\u00edm v\u0161eobecn\u00fdch bezpe\u010dnostn\u00fdch a v\u00fdkonov\u00fdch po\u017eiadaviek IVDR at\u010f.). Laborat\u00f3ri\u00e1 musia vy\u010dleni\u0165 zna\u010dn\u00e9 prostriedky na pochopenie po\u017eiadaviek dan\u00fdch IVDR a na dodr\u017eiavanie tohto nov\u00e9ho nariadenia. Prevencia v\u00fdvoja LDT hne\u010f, ako bude k dispoz\u00edcii jeden test ozna\u010den\u00fd zna\u010dkou CE, podpor\u00ed monopoly a riziko zlyhania pri optimaliz\u00e1cii diagnostiky variantov, ako je to v pr\u00edpade SARS-CoV-2 a&nbsp;kancer\u00f3znych variantov odoln\u00fdch liekom.<\/p>\n\n\n\n<p>Eur\u00f3pska komisia spolu s pr\u00edslu\u0161n\u00fdmi vn\u00fatro\u0161t\u00e1tnymi org\u00e1nmi mus\u00ed vypracova\u0165 jasn\u00e9 a vhodn\u00e9 usmernenie k LDT, ktor\u00e9 u\u013eah\u010d\u00ed harmoniz\u00e1ciu po\u017eiadaviek IVDR na \u00farovni E\u00da, pri\u010dom zoh\u013eadn\u00ed vstupy od pr\u00edslu\u0161n\u00fdch zainteresovan\u00fdch str\u00e1n. To zabezpe\u010d\u00ed optim\u00e1lnu kvalitu testu, ale tie\u017e to, \u017ee regula\u010dn\u00e1 z\u00e1\u0165a\u017e pre laborat\u00f3ri\u00e1 nebude vy\u0161\u0161ia, ako je nevyhnutne potrebn\u00e9. Malo by sa tak sta\u0165 \u010do najsk\u00f4r, aby sme pomohli laborat\u00f3ri\u00e1m pokra\u010dova\u0165 v pr\u00edpravn\u00fdch pr\u00e1cach a zaru\u010dili pokra\u010dovanie \u00fa\u010dinnej a kvalitnej diagnostickej starostlivosti zalo\u017eenej na LDT po m\u00e1ji 2022.<\/p>\n\n\n\n<p><strong><span style=\"color:#f20808\" class=\"has-inline-color\">K\u013e\u00fa\u010dov\u00e9 posolstv\u00e1<\/span><\/strong><\/p>\n\n\n\n<p><span style=\"color:#f20808\" class=\"has-inline-color\">Eur\u00f3pska komisia a \u010dlensk\u00e9 \u0161t\u00e1ty musia teraz:<\/span><\/p>\n\n\n\n<p>\u2022<span class=\"has-inline-color has-vivid-red-color\"> &nbsp; <\/span><span style=\"color:#f20808\" class=\"has-inline-color\"><strong>pripravi\u0165<\/strong> a <strong>zverejni\u0165<\/strong> pohotovostn\u00e9 pl\u00e1ny implement\u00e1cie IVDR, ktor\u00e9 neohrozia dostupnos\u0165 ak\u00fdchko\u013evek z\u00e1kladn\u00fdch medic\u00ednskych diagnostick\u00fdch laborat\u00f3rnych testov<\/span><\/p>\n\n\n\n<p>\u2022 &nbsp; <span style=\"color:#f20808\" class=\"has-inline-color\"><strong>ur\u00fdchli\u0165<\/strong> pr\u00edpravu usmer\u0148ovac\u00edch dokumentov<\/span><\/p>\n\n\n\n<p>\u2022 &nbsp; <span style=\"color:#f20808\" class=\"has-inline-color\"><strong>spolupracova\u0165<\/strong> so v\u0161etk\u00fdmi pr\u00edslu\u0161n\u00fdmi zainteresovan\u00fdmi stranami, aby sa zabr\u00e1nilo kolapsu lek\u00e1rskej diagnostiky.<\/span><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"has-inline-color has-black-color\">11. 6 .2021 <\/span><br><span style=\"color:#040f8d\" class=\"has-inline-color\"><strong>Nes\u00falad medzi regula\u010dn\u00fdmi ustanoveniami E\u00da a klinickou potrebou zdravotn\u00edckych pom\u00f4cok s IVD<\/strong><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td><span style=\"color:#035b30\" class=\"has-inline-color\"><strong>Laborat\u00f3rne diagnostick\u00e9 testy nevyhnutn\u00e9 pre klinick\u00fa prax a&nbsp;zdravotn\u00fa starostlivos\u0165: s\u00fa\u010dasn\u00fd stav a regula\u010dn\u00e9 ustanovenia<\/strong><\/span><\/td><td><span class=\"has-inline-color has-luminous-vivid-orange-color\"><strong>Stav implement\u00e1cie nov\u00e9ho nariadenia o diagnostick\u00fdch zdravotn\u00edckych pom\u00f4ckach in vitro (E\u00da) 2017\/746 (IVDR)<\/strong><\/span><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"has-text-align-center wp-block-heading\"><strong><span style=\"color:#040f8d\" class=\"has-inline-color\">Medic\u00ednske testy so zna\u010dkou CE<\/span><\/strong><\/h4>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td class=\"has-text-align-left\" data-align=\"left\"><span style=\"color:#035b30\" class=\"has-inline-color\"><strong>V medic\u00ednskej praxi sa pou\u017e\u00edva viac ako 27 000 laborat\u00f3rnych diagnostick\u00fdch testov (IVD)<\/strong><br><br>Pod\u013ea smernice E\u00da 98\/79 \/ ES (IVDD)<br>o Diagnostick\u00fdch medic\u00ednskych pom\u00f4ckach in vitro mus\u00ed <strong>notifikovan\u00fd org\u00e1n skontrolova\u0165 takmer 10% laborat\u00f3rnych diagnostick\u00fdch testov<\/strong><br><br>Na certifik\u00e1ciu testov IVD pod\u013ea IVDD<sup>1<\/sup> je schv\u00e1len\u00fdch <strong>18 notifikovan\u00fdch org\u00e1nov<\/strong><br>Proces ur\u010denia notifikovan\u00e9ho org\u00e1nu pod\u013ea predpisov E\u00da o zdravotn\u00edckych pom\u00f4ckach <strong>trv\u00e1 asi 700 dn\u00ed <\/strong><br><br>Pos\u00fadenie \u017eiadosti o certifik\u00e1t CE pre IVD pom\u00f4cku predlo\u017eenej <strong>v\u00fdrobcom trv\u00e1 asi<br>10 mesiacov<\/strong><\/span><\/td><td><span class=\"has-inline-color has-luminous-vivid-orange-color\"><strong>D\u00e1tum za\u010diatku<\/strong> uplat\u0148ovania nov\u00e9ho nariadenia IVDR je <strong>26. m\u00e1j 2022<\/strong><br><br><strong>90% testov IVD (asi 19 000) si bude po prv\u00fdkr\u00e1t vy\u017eadova\u0165 pos\u00fadenie zhody notifikovan\u00fdm org\u00e1nom pod\u013ea IVDR <\/strong><br><br><strong>Pre IVDR boli doteraz ur\u010den\u00e9 iba 4 notifikovan\u00e9 org\u00e1ny<\/strong> <br><br>O\u010dak\u00e1va sa, \u017ee v priebehu nasleduj\u00facich 6 mesiacov bude menovan\u00fd iba <strong>1 <\/strong>\u010fal\u0161\u00ed <strong>notifikovan\u00fd org\u00e1n<\/strong> <br><br><strong>Pod\u013ea IVDR bolo doteraz schv\u00e1len\u00fdch iba 7 testov IVD<sup>2<\/sup> <\/strong><br><br>Prebieha presk\u00famanie \u010fal\u0161\u00edch 249 testov<sup>2 <\/sup><br><br><strong>78% v\u00fdrobcov IVD <\/strong>uviedlo \u0165a\u017ekosti so schv\u00e1len\u00edm svojich testov z d\u00f4vodu nedostatku kapacity notifikovan\u00e9ho org\u00e1nu<sup>3<\/sup> <br><br><strong>Testy ozna\u010den\u00e9 CE,<\/strong> ktor\u00e9 nem\u00f4\u017eu podst\u00fapi\u0165 hodnotenie notifikovan\u00fdm org\u00e1nom<strong>, u\u017e nebud\u00fa k dispoz\u00edcii pre pacientov, ktor\u00ed ich potrebuj\u00fa<\/strong><\/span><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"has-text-align-center wp-block-heading\"><span style=\"color:#040f8d\" class=\"has-inline-color\"><strong>Diagnostick\u00e9 testy vyvinut\u00e9 v&nbsp;laborat\u00f3riu <\/strong><br><strong>(dom\u00e1ce testy, \u201ein house\u201c)<\/strong><\/span><\/h4>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td><span style=\"color:#035b30\" class=\"has-inline-color\">Typick\u00e1 univerzitn\u00e1 nemocnica vykon\u00e1va 922 r\u00f4znych laborat\u00f3rnych diagnostick\u00fdch testov<sup>4 <\/sup><br><br>47% s\u00fa dom\u00e1ce laborat\u00f3rne testy;<br>pre 72% z nich neexistuje komer\u010dne dostupn\u00e1 alternat\u00edva<\/span><\/td><td><span class=\"has-inline-color has-luminous-vivid-orange-color\">Regula\u010dn\u00fd doh\u013ead nad laborat\u00f3rne vyvinut\u00fdmi testami bol delegovan\u00fd na \u010dlensk\u00e9 \u0161t\u00e1ty E\u00da, ale usmernenie e\u0161te nebolo zverejnen\u00e9 Vplyv IVDR na dostupnos\u0165 laborat\u00f3rne vyvinut\u00fdch testov vy\u017eaduje form\u00e1lne vyhodnotenie<\/span><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ol class=\"wp-block-list\" type=\"1\"><li>List of Bodies Notified under Directive: 98\/79\/EC In vitro diagnostic medical devices. (Accessed 7 May 2021) <a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.pdf&amp;refe_cd=98%2F79%2FEC&amp;requesttimeout=900\">https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.pdf&amp;refe_cd=98%2F79%2FEC&amp;requesttimeout=900<\/a><\/li><li>Information provided by the European Commission on 22 April 2021.<\/li><li>European Commission Survey on IVDR preparedness, 27 Jan \u2013 16 Feb 2021; courtesy of MedTech Europe.<\/li><li>Vermeersch P et al. The new IVD Regulation 2017\/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab developed tests to improve patient care. Clin Chem Lab Med. 2020;59(1):101-6.&nbsp;<\/li><\/ol>\n","protected":false},"excerpt":{"rendered":"<p>22.7.2021 Odpove\u010f Ministerstva zdravorn\u00edctva SR na v\u00fdzvu \u010dasov\u00e9ho odkladu implement\u00e1cie nariadenia (E\u00da) 207\/746 o diagnostick\u00fdch zdravotn\u00edckych pom\u00f4ckach in vitro a o zru\u0161en\u00ed smernice 98\/79\/ES a rozhodnutia Komisie 2010\/227\/E\u00da si m\u00f4\u017eete pre\u010d\u00edta\u0165 TU.\u00a0 12.7.2021Nadch\u00e1dzaj\u00face svetov\u00e9 a region\u00e1lne kongresy 7.7.2021 IFCC Handbook 2021 &#8211; 2023 Medzin\u00e1rodn\u00e1 feder\u00e1cia klinickej ch\u00e9mie a laborat\u00f3rnej medic\u00edny (IFCC) je celosvetov\u00e1 nepolitick\u00e1 organiz\u00e1cia [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8],"tags":[],"class_list":["post-3287","post","type-post","status-publish","format-standard","hentry","category-informacie-z-eflm-a-ifcc"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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