{"id":10790,"date":"2026-06-23T10:01:39","date_gmt":"2026-06-23T09:01:39","guid":{"rendered":"https:\/\/www.sskb.sk\/2022\/?p=10790"},"modified":"2026-06-23T10:01:40","modified_gmt":"2026-06-23T09:01:40","slug":"stanovisko-eflm-k-navrhovanemu-dodatku-2025-0404cod-ivdr-k-clanku-5-5","status":"publish","type":"post","link":"https:\/\/www.sskb.sk\/2022\/stanovisko-eflm-k-navrhovanemu-dodatku-2025-0404cod-ivdr-k-clanku-5-5\/","title":{"rendered":"Stanovisko EFLM k navrhovan\u00e9mu dodatku 2025\/0404(COD) IVDR k \u010dl\u00e1nku 5.5"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Eur\u00f3pska komisia (EK) 16. decembra 2025 zverejnila legislat\u00edvny n\u00e1vrh 2025\/0404(COD) na cielen\u00fa rev\u00edziu nariadenia E\u00da 2017\/746 (IVDR), ktor\u00e9 tr\u00e1pia z\u00e1va\u017en\u00e9 probl\u00e9my s implement\u00e1ciou. V pr\u00edpade komer\u010dn\u00fdch testov IVD (CE-IVD) patria medzi probl\u00e9my \u00fazke miesta v certifik\u00e1cii, nedostatok pom\u00f4cok, stiahnutie IVD z trhu a oneskoren\u00e9 inov\u00e1cie, ktor\u00e9 ovplyv\u0148uj\u00fa dostupnos\u0165 a konkurencieschopnos\u0165. Z\u00e1\u0165a\u017e tie\u017e ne\u00famerne postihuje mal\u00fdch a\u00a0stredn\u00fdch v\u00fdrobcov v oblasti v\u00fdroby diagnost\u00edk vr\u00e1tane poskytovate\u013eov \u0161pecializovan\u00fdch testov a testov na vz\u00e1cne ochorenia. V pr\u00edpade intern\u00fdch testov (<em>in-house<\/em>) sa zdravotn\u00edcke zariadenia, ktor\u00e9 ich poskytuj\u00fa, stret\u00e1vaj\u00fa s prek\u00e1\u017ekami, ktor\u00e9 s\u00favisia najm\u00e4 so \u0161kodliv\u00fdmi obmedzeniami a neprimeran\u00fdmi po\u017eiadavkami, ako je op\u00edsan\u00e9 v \u010dl\u00e1nku 5.5 nariadenia IVDR. Hoci sa EK sna\u017eila prinies\u0165 na trh E\u00da bezpe\u010dn\u00e9 a \u00fa\u010dinn\u00e9 lek\u00e1rske testy, zo 40 000 testov sa po\u010das prechodu stratilo pribli\u017ene 9 000. Z n\u00e1\u0161ho poh\u013eadu ako odborn\u00edkov v laborat\u00f3rnej diagnostike s\u00fa nezam\u00fd\u0161\u013ean\u00e9 d\u00f4sledky po\u0161kodenia pacientov v d\u00f4sledku nedostatku a nedostupnosti v\u00fdraznej\u0161ie, \u010d\u00edm sa m\u00ed\u0148aj\u00fa k\u013e\u00fa\u010dov\u00e9 ciele IVDR, ktor\u00fdmi s\u00fa podpora bezpe\u010dn\u00fdch a \u00fa\u010dinn\u00fdch lek\u00e1rskych testov in vitro na trhu E\u00da v jeho s\u00fa\u010dasnej podobe.<\/p>\n\n<p class=\"wp-block-paragraph\">EFLM Komisia pre eur\u00f3pske regula\u010dn\u00e9 z\u00e1le\u017eitosti (CERA) v minulosti pravidelne poukazovala na v\u00fdzvy spojen\u00e9 s IVDR. Jej stanovisko kladie d\u00f4raz na bezpe\u010dnos\u0165 a pr\u00ednosy pre pacientov. V tomto stanovisku poukazuje na siln\u00e9 a slab\u00e9 str\u00e1nky n\u00e1vrhu reformy 2025\/0404(COD) v s\u00favislosti s intern\u00fdmi testami op\u00edsan\u00fdmi v \u010dl\u00e1nku 5.5. IVDR. D\u00f4razne sa zasadzuje za to, aby politika E\u00da v oblasti zdravia prijala zmeny a doplnenia uveden\u00e9 v tomto dokumente. Presadzovanie s\u00fa\u010dasn\u00fdch prakt\u00edk, ktor\u00e9 br\u00e1nia poskytovaniu zdravotnej starostlivosti, bezpe\u010dnosti a v\u010dasn\u00fdm diagnostick\u00fdm slu\u017eb\u00e1m, bude na\u010falej nielen znev\u00fdhod\u0148ova\u0165 pacientov, ktor\u00fdm by mala by\u0165 venovan\u00e1 pozornos\u0165, ale pravdepodobne bude aj \u0161kodliv\u00e9 pre trval\u00e9 ved\u00face postavenie Eur\u00f3pskej \u00fanie v oblasti inov\u00e1ci\u00ed v diagnostickej medic\u00edne.<\/p>\n\n<p class=\"wp-block-paragraph\">Reforma nariadenia o in vitro diagnostike zo strany Eur\u00f3pskej komisie zah\u0155\u0148a kateg\u00f3rie, ktor\u00e9 priamo menia prax v oblasti in vitro diagnostiky:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Zjednodu\u0161enie a zn\u00ed\u017eenie administrat\u00edvnej z\u00e1\u0165a\u017ee<\/li>\n\n<li>Moderniz\u00e1ciu d\u00f4kazov a klinick\u00e9ho v\u00fdkonu<\/li>\n\n<li>Inov\u00e1ciu a dostupnos\u0165 ustanoven\u00ed<\/li>\n\n<li>Digitaliz\u00e1ciu a\u00a0koordin\u00e1ciu medzi pr\u00edslu\u0161n\u00fdmi org\u00e1nmi..<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">CERA vykonala kritick\u00fa anal\u00fdzu navrhovan\u00fdch reforiem nariadenia o in vitro diagnostike a\u00a0zhrnula ich siln\u00e9 a\u00a0slab\u00e9 str\u00e1nky. Rozvinula sa v\u00fdznamn\u00e1 diskusia o ustanoveniach \u010dl\u00e1nku 5.5 a jeho 9 pododsekoch (a\u2013i). CERA vypracovala porovnanie \u010dl\u00e1nku 5.5 v nariaden\u00ed IVDR 2017\/746 s \u010dl\u00e1nkom 5.5 v nariaden\u00ed 2025\/0404 (COD). \u010cl\u00e1nok 5.5 je pr\u00edli\u0161 pr\u00edsny, zameran\u00fd na dokument\u00e1ciu a br\u00e1ni v\u00fdvoju, valid\u00e1cii a pou\u017e\u00edvaniu z\u00e1kladn\u00fdch a personalizovan\u00fdch diagnostick\u00fdch testov v klinick\u00fdch postupoch. CERA uv\u00e1dza siln\u00e9 argumenty na \u00fapravu \u010dl\u00e1nku 5.5. a o\u010dak\u00e1va zmeny zameran\u00e9 na odstr\u00e1nenie po\u017eiadavky na od\u00f4vodnenie ekvivalencie; zn\u00ed\u017eenie povinnost\u00ed t\u00fdkaj\u00facich sa dokument\u00e1cie; harmoniz\u00e1ciu vn\u00fatro\u0161t\u00e1tnych interpret\u00e1ci\u00ed, zn\u00ed\u017eenie za\u0165a\u017eenia lek\u00e1rskych laborat\u00f3ri\u00ed a predov\u0161etk\u00fdm na predch\u00e1dzanie po\u0161kodeniu pacientov.<\/p>\n\n<p class=\"wp-block-paragraph\">Navrhovan\u00e1 reforma nariadenia o IVDR sa jasne zameriava na zv\u00fd\u0161enie flexibility a kontextualiz\u00e1cie. Predt\u00fdm, ako sa stane pr\u00e1vnym predpisom, ju v\u0161ak mus\u00ed schv\u00e1li\u0165 Eur\u00f3psky parlament a Eur\u00f3pska rada. Pre \u00fapln\u00e9 pochopenie vplyvu n\u00e1vrhu 2025\/404(COD) nariadenia o IVDR tabu\u013eka 1 poskytuje porovnanie s\u00fa\u010dasn\u00fdch a navrhovan\u00fdch po\u017eiadaviek \u010dl\u00e1nku 5.5 nariadenia o IVDR.<\/p>\n\n<figure>\n<table>\n<tbody>\n<tr>\n<td colspan=\"4\"><strong>Porovnanie s\u00fa\u010dasn\u00fdch regula\u010dn\u00fdch po\u017eiadaviek pod\u013ea \u010cl\u00e1nku 5.5 v nariaden\u00ed o IVDR a zmien a doplnen\u00ed pod\u013ea \u010dl\u00e1nku navrhnut\u00fdch v (COD)<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td><strong>P\u00f4vodn\u00fd \u010dl\u00e1nok 5.5 uveden\u00fd<\/strong> <strong>v IVDR 2017\/746<\/strong><\/td>\n<td><strong>Revidovan\u00fd \u010dl\u00e1nok 5.5 navrhnut\u00fd 2025\/0404 (COD)<\/strong><\/td>\n<td><strong>Dopl\u0148uj\u00face pozn\u00e1mky k (COD)<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.a<\/td>\n<td>Pom\u00f4cky sa <strong>neprev\u00e1dzaj\u00fa <\/strong>na in\u00fd pr\u00e1vny subjekt;<\/td>\n<td>Pom\u00f4cky sa <strong>neprev\u00e1dzaj\u00fa <\/strong>na in\u00fd pr\u00e1vny subjekt, s <strong>v\u00fdnimkou<\/strong> in\u00e9ho zdravotn\u00edckeho zariadenia<strong> v riadne od\u00f4vodnenom z\u00e1ujme verejn\u00e9ho zdravia, bezpe\u010dnosti alebo zdravia pacientov, alebo na \u00fa\u010dely pr\u00edpravy alebo reakcie na n\u00fadzov\u00fd stav v oblasti verejn\u00e9ho zdravia.<\/strong><\/td>\n<td rowspan=\"3\">V pr\u00edpade prevodu pom\u00f4cky do in\u00e9ho zdravotn\u00edckeho zariadenia <strong>zabezpe\u010dia prev\u00e1dzaj\u00face a prij\u00edmaj\u00face zdravotn\u00edcke zariadenia vysledovate\u013enos\u0165 pom\u00f4cky<\/strong>.<br \/>Prij\u00edmaj\u00face zdravotn\u00edcke zariadenie <strong>ozn\u00e1mi ak\u00fdko\u013evek incident<\/strong> s\u00favisiaci s pom\u00f4ckou prev\u00e1dzaj\u00facemu zdravotn\u00edckemu zariadeniu.<br \/>Tento odsek sa <strong>vz\u0165ahuje aj na pom\u00f4cky<\/strong> vyroben\u00e9 a pou\u017e\u00edvan\u00e9 v laborat\u00f3riu, ktor\u00e9 m\u00e1 s\u00eddlo v \u00danii a poskytuje konzistentn\u00e9, najmodernej\u0161ie testovacie slu\u017eby pre klinick\u00fd v\u00fdskum, za predpokladu, \u017ee tieto pom\u00f4cky s\u00fa ur\u010den\u00e9 v\u00fdlu\u010dne na pou\u017eitie v r\u00e1mci <strong>klinick\u00e9ho sk\u00fa\u0161ania pod\u013ea nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) \u010d. 1997\/2018*<\/strong>.<\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.c<\/td>\n<td>Laborat\u00f3rium zdravotn\u00edckeho zariadenia je v s\u00falade s normou EN ISO 15189 alebo pr\u00edpadne s vn\u00fatro\u0161t\u00e1tnymi ustanoveniami vr\u00e1tane vn\u00fatro\u0161t\u00e1tnych opatren\u00ed t\u00fdkaj\u00facich sa akredit\u00e1cie;<\/td>\n<td>Laborat\u00f3rium zdravotn\u00edckeho zariadenia je v s\u00falade s normou EN ISO 15189 alebo, ak je to relevantn\u00e9, s n\u00e1rodn\u00fdmi ustanoveniami o kvalite a kompetencii v zdravotn\u00edckych laborat\u00f3ri\u00e1ch vr\u00e1tane n\u00e1rodn\u00fdch ustanoven\u00ed t\u00fdkaj\u00facich sa akredit\u00e1cie.<\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.d<\/td>\n<td>Zdravotn\u00edcke zariadenie vo svojej dokument\u00e1cii od\u00f4vodn\u00ed, \u017ee \u0161pecifick\u00e9 potreby cie\u013eovej skupiny pacientov nie je mo\u017en\u00e9 splni\u0165 alebo nie je mo\u017en\u00e9 splni\u0165 na primeranej \u00farovni v\u00fdkonu ekvivalentnou pom\u00f4ckou dostupnou na trhu;<\/td>\n<td><strong>VYMAZAN\u00c9!<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.e<\/td>\n<td>Zdravotn\u00edcke zariadenie poskytuje na po\u017eiadanie inform\u00e1cie o pou\u017e\u00edvan\u00ed tak\u00fdchto pom\u00f4cok svojmu pr\u00edslu\u0161n\u00e9mu org\u00e1nu, ktor\u00e9 musia obsahova\u0165 od\u00f4vodnenie ich v\u00fdroby, \u00fapravy a pou\u017e\u00edvania;<\/td>\n<td>Na \u017eiados\u0165 pr\u00edslu\u0161n\u00e9ho org\u00e1nu poskytne zdravotn\u00edcke zariadenie inform\u00e1cie o pou\u017e\u00edvan\u00ed tak\u00fdchto pom\u00f4cok tomuto org\u00e1nu vr\u00e1tane od\u00f4vodnenia uveden\u00e9ho v p\u00edsmene a).<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.f. (i.i.i.)<\/td>\n<td>Vyhl\u00e1senie, \u017ee pom\u00f4cky sp\u013a\u0148aj\u00fa v\u0161eobecn\u00e9 po\u017eiadavky na bezpe\u010dnos\u0165 a v\u00fdkon stanoven\u00e9 v pr\u00edlohe I k tomuto nariadeniu a v pr\u00edpade potreby inform\u00e1cie o tom, ktor\u00e9 po\u017eiadavky nie s\u00fa \u00faplne splnen\u00e9, s od\u00f4vodnen\u00edm;<\/td>\n<td>Vyhl\u00e1senie, \u017ee zdravotn\u00edcke zariadenie je akreditovan\u00e9 pod\u013ea normy uvedenej v p\u00edsmene c), alebo \u017ee pom\u00f4cky sp\u013a\u0148aj\u00fa pr\u00edslu\u0161n\u00e9 v\u0161eobecn\u00e9 po\u017eiadavky na bezpe\u010dnos\u0165 a v\u00fdkon stanoven\u00e9 v Pr\u00edlohe I a v pr\u00edpade potreby inform\u00e1cie o tom, ktor\u00e9 po\u017eiadavky nie s\u00fa \u00faplne splnen\u00e9, s od\u00f4vodnen\u00edm.<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.g<\/td>\n<td>Pokia\u013e ide o pom\u00f4cky triedy D v s\u00falade s pravidlami stanoven\u00fdmi v Pr\u00edlohe VIII, zdravotn\u00edcke zariadenie vypracuje dokument\u00e1ciu, ktor\u00e1 umo\u017e\u0148uje pochopi\u0165 v\u00fdrobn\u00e9 zariadenie, v\u00fdrobn\u00fd proces, kon\u0161trukciu a v\u00fdkonnostn\u00e9 \u00fadaje pom\u00f4cok vr\u00e1tane ur\u010den\u00e9ho \u00fa\u010delu a ktor\u00e1 je dostato\u010dne podrobn\u00e1 na to, aby pr\u00edslu\u0161n\u00fd org\u00e1n mohol overi\u0165, \u010di s\u00fa splnen\u00e9 v\u0161eobecn\u00e9 po\u017eiadavky na bezpe\u010dnos\u0165 a v\u00fdkon stanoven\u00e9 v Pr\u00edlohe I k tomuto Nariadeniu. \u010clensk\u00e9 \u0161t\u00e1ty m\u00f4\u017eu toto ustanovenie uplatni\u0165 aj na pom\u00f4cky triedy A, B alebo C v s\u00falade s pravidlami stanoven\u00fdmi v Pr\u00edlohe VIII;<\/td>\n<td>Pokia\u013e ide o pom\u00f4cky triedy D v s\u00falade s pravidlami stanoven\u00fdmi v Pr\u00edlohe VIII, ak zdravotn\u00edcke zariadenie nie je akreditovan\u00e9 pod\u013ea normy uvedenej v p\u00edsmene c), zdravotn\u00edcke zariadenie vypracuje dostato\u010dne podrobn\u00fa dokument\u00e1ciu, aby pr\u00edslu\u0161n\u00fd org\u00e1n mohol overi\u0165, \u010di s\u00fa splnen\u00e9 pr\u00edslu\u0161n\u00e9 v\u0161eobecn\u00e9 po\u017eiadavky na bezpe\u010dnos\u0165 a v\u00fdkon stanoven\u00e9 v Pr\u00edlohe I.<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>\u010cl. 5.5.h<\/td>\n<td>Zdravotn\u00edcke zariadenie prijme v\u0161etky potrebn\u00e9 opatrenia na zabezpe\u010denie toho, aby v\u0161etky pom\u00f4cky boli vyroben\u00e9 v s\u00falade s dokument\u00e1ciou uvedenou v p\u00edsmene g);<\/td>\n<td><strong>VYMAZAN\u00c9!<\/strong><\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n<p class=\"wp-block-paragraph\">\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Eur\u00f3pska komisia (EK) 16. decembra 2025 zverejnila legislat\u00edvny n\u00e1vrh 2025\/0404(COD) na cielen\u00fa rev\u00edziu nariadenia E\u00da 2017\/746 (IVDR), ktor\u00e9 tr\u00e1pia z\u00e1va\u017en\u00e9 probl\u00e9my s implement\u00e1ciou. V pr\u00edpade komer\u010dn\u00fdch testov IVD (CE-IVD) patria medzi probl\u00e9my \u00fazke miesta v certifik\u00e1cii, nedostatok pom\u00f4cok, stiahnutie IVD z trhu a oneskoren\u00e9 inov\u00e1cie, ktor\u00e9 ovplyv\u0148uj\u00fa dostupnos\u0165 a konkurencieschopnos\u0165. Z\u00e1\u0165a\u017e tie\u017e ne\u00famerne postihuje mal\u00fdch [&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-10790","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 v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Stanovisko EFLM k navrhovan\u00e9mu dodatku 2025\/0404(COD) IVDR k \u010dl\u00e1nku 5.5 - SSKB SLS<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sskb.sk\/2022\/stanovisko-eflm-k-navrhovanemu-dodatku-2025-0404cod-ivdr-k-clanku-5-5\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Stanovisko EFLM k navrhovan\u00e9mu dodatku 2025\/0404(COD) IVDR k \u010dl\u00e1nku 5.5 - SSKB SLS\" \/>\n<meta property=\"og:description\" content=\"Eur\u00f3pska komisia (EK) 16. decembra 2025 zverejnila legislat\u00edvny n\u00e1vrh 2025\/0404(COD) na cielen\u00fa rev\u00edziu nariadenia E\u00da 2017\/746 (IVDR), ktor\u00e9 tr\u00e1pia z\u00e1va\u017en\u00e9 probl\u00e9my s implement\u00e1ciou. V pr\u00edpade komer\u010dn\u00fdch testov IVD (CE-IVD) patria medzi probl\u00e9my \u00fazke miesta v certifik\u00e1cii, nedostatok pom\u00f4cok, stiahnutie IVD z trhu a oneskoren\u00e9 inov\u00e1cie, ktor\u00e9 ovplyv\u0148uj\u00fa dostupnos\u0165 a konkurencieschopnos\u0165. 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