{"id":2733,"date":"2025-12-05T10:00:47","date_gmt":"2025-12-05T09:00:47","guid":{"rendered":"https:\/\/www.beautypristroje.sk\/?p=2733"},"modified":"2025-12-06T12:01:21","modified_gmt":"2025-12-06T11:01:21","slug":"mdr-regulacia-a-povinnosti-pri-pouzivani-beauty-pristrojov","status":"publish","type":"post","link":"https:\/\/www.beautypristroje.sk\/en\/mdr-regulacia-a-povinnosti-pri-pouzivani-beauty-pristrojov\/","title":{"rendered":"MDR regul\u00e1cia a povinnosti pri pou\u017e\u00edvan\u00ed beauty pr\u00edstrojov"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2733\" class=\"elementor elementor-2733\" wpc-filter-elementor-widget=\"1\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3eb08951 e-flex e-con-boxed e-con e-parent\" data-id=\"3eb08951\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5e813e6c elementor-widget elementor-widget-text-editor\" data-id=\"5e813e6c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<p data-start=\"209\" data-end=\"440\">Eur\u00f3pska legislat\u00edva v oblasti estetick\u00fdch technol\u00f3gi\u00ed pre\u0161la v posledn\u00fdch rokoch v\u00fdraznou zmenou. Nariadenie MDR (Medical Device Regulation 2017\/745) ur\u010duje jasn\u00e9 pravidl\u00e1 pre pr\u00edstroje pou\u017e\u00edvan\u00e9 v kozmetike, estetike aj medic\u00edne.<\/p>\n<p data-start=\"442\" data-end=\"610\">Pre sal\u00f3ny je k\u013e\u00fa\u010dov\u00e9 rozumie\u0165 rozdielu medzi zdravotn\u00edckou pom\u00f4ckou a pr\u00edstrojom bez medic\u00ednskeho \u00fa\u010delu, aby pracovali v s\u00falade so z\u00e1konom a chr\u00e1nili klientov aj seba.<\/p>\n<p data-start=\"612\" data-end=\"762\">Ako predajcovia profesion\u00e1lnych beauty technol\u00f3gi\u00ed poskytujeme v\u0161etky potrebn\u00e9 dokumenty, certifik\u00e1cie a odborn\u00e9 podklady, ktor\u00e9 s\u00fa pod\u013ea MDR povinn\u00e9.<\/p>\n<h3 class=\"wp-block-heading\" data-start=\"765\" data-end=\"800\">\u00a0<\/h3>\n<h4 data-start=\"765\" data-end=\"800\">\u010co presne znamen\u00e1 MDR 2017\/745?<\/h4>\n<p data-start=\"802\" data-end=\"839\">MDR je nariadenie E\u00da, ktor\u00e9 upravuje:<\/p>\n<p data-start=\"841\" data-end=\"1162\">\u2022 klasifik\u00e1ciu pr\u00edstrojov pod\u013ea \u00fa\u010delu pou\u017eitia<br data-start=\"887\" data-end=\"890\" \/>\u2022 povinnosti v\u00fdrobcu, distrib\u00fatora aj pou\u017e\u00edvate\u013ea<br data-start=\"939\" data-end=\"942\" \/>\u2022 technick\u00fa dokument\u00e1ciu a klinick\u00e9 hodnotenie<br data-start=\"988\" data-end=\"991\" \/>\u2022 povinn\u00e9 registr\u00e1cie v syst\u00e9me EUDAMED<br data-start=\"1030\" data-end=\"1033\" \/>\u2022 sledovanie bezpe\u010dnosti v\u00fdrobkov na trhu<br data-start=\"1074\" data-end=\"1077\" \/>\u2022 po\u017eiadavky na CE ozna\u010denie<br data-start=\"1105\" data-end=\"1108\" \/>\u2022 rizikovos\u0165 pr\u00edstrojov a ich zaradenie do kateg\u00f3ri\u00ed<\/p>\n<p data-start=\"1164\" data-end=\"1302\">Hlavn\u00fdm cie\u013eom MDR je zabezpe\u010di\u0165, \u017ee v\u0161etky pr\u00edstroje pou\u017e\u00edvan\u00e9 v E\u00da s\u00fa bezpe\u010dn\u00e9, technicky overen\u00e9 a maj\u00fa jasne definovan\u00fd \u00fa\u010del pou\u017eitia.<\/p>\n<h3 data-start=\"1305\" data-end=\"1365\">\u00a0<\/h3>\n<h4 data-start=\"1305\" data-end=\"1365\">Zdravotn\u00edcka pom\u00f4cka vs. pr\u00edstroj bez medic\u00ednskeho \u00fa\u010delu<\/h4>\n<h4 data-start=\"1367\" data-end=\"1412\">\u00a0<\/h4>\n<h5 data-start=\"1367\" data-end=\"1412\">1. Zdravotn\u00edcka pom\u00f4cka (Medical Device)<\/h5>\n<p data-start=\"1414\" data-end=\"1479\">Pr\u00edstroj spad\u00e1 pod MDR ako zdravotn\u00edcka pom\u00f4cka, ak je ur\u010den\u00fd na:<\/p>\n<p data-start=\"1481\" data-end=\"1583\">\u2022 lie\u010dbu<br data-start=\"1489\" data-end=\"1492\" \/>\u2022 korekciu<br data-start=\"1502\" data-end=\"1505\" \/>\u2022 diagnostiku<br data-start=\"1518\" data-end=\"1521\" \/>\u2022 prevenciu ochoren\u00ed<br data-start=\"1541\" data-end=\"1544\" \/>\u2022 terapeutick\u00e9 alebo medic\u00ednske \u00fa\u010dely<\/p>\n<p data-start=\"1585\" data-end=\"1613\">Tak\u00e9to zariadenia musia ma\u0165:<\/p>\n<p data-start=\"1615\" data-end=\"1809\">\u2022 CE ozna\u010denie pod\u013ea triedy I, IIa, IIb alebo III<br data-start=\"1664\" data-end=\"1667\" \/>\u2022 klinick\u00fa dokument\u00e1ciu<br data-start=\"1690\" data-end=\"1693\" \/>\u2022 prehl\u00e1senie o zhode pod\u013ea MDR<br data-start=\"1724\" data-end=\"1727\" \/>\u2022 registr\u00e1ciu v EUDAMED<br data-start=\"1750\" data-end=\"1753\" \/>\u2022 technick\u00fa dokument\u00e1ciu podlo\u017een\u00fa testami a meraniami<\/p>\n<p data-start=\"1811\" data-end=\"1917\">Tieto pr\u00edstroje m\u00f4\u017ee pou\u017e\u00edva\u0165 iba zdravotn\u00edcky person\u00e1l alebo klinick\u00e9 pracovisk\u00e1, pod\u013ea typu technol\u00f3gie.<\/p>\n<h4 data-start=\"1920\" data-end=\"1982\">\u00a0<\/h4>\n<h5 data-start=\"1920\" data-end=\"1982\">2. Pr\u00edstroje bez medic\u00ednskeho \u00fa\u010delu (non-medical devices)<\/h5>\n<p data-start=\"1984\" data-end=\"2025\">Patria sem zariadenia ur\u010den\u00e9 v\u00fdhradne na:<\/p>\n<p data-start=\"2027\" data-end=\"2154\">\u2022 skr\u00e1\u0161\u013euj\u00faci \u00fa\u010dinok<br data-start=\"2047\" data-end=\"2050\" \/>\u2022 estetick\u00e9 \u00fapravy<br data-start=\"2068\" data-end=\"2071\" \/>\u2022 zlep\u0161enie kvality poko\u017eky<br data-start=\"2098\" data-end=\"2101\" \/>\u2022 lifting a rejuveniz\u00e1ciu<br data-start=\"2126\" data-end=\"2129\" \/>\u2022 neinvaz\u00edvne proced\u00fary<\/p>\n<p data-start=\"2156\" data-end=\"2352\">Tieto pr\u00edstroje nesm\u00fa deklarova\u0165 lie\u010debn\u00e9 \u00fa\u010dinky ani prenika\u0165 do medic\u00ednskej h\u013abky. Musia v\u0161ak sp\u013a\u0148a\u0165 v\u0161etky technick\u00e9 a bezpe\u010dnostn\u00e9 po\u017eiadavky smernice o v\u0161eobecnej bezpe\u010dnosti produktov (GPSD).<\/p>\n<p data-start=\"2354\" data-end=\"2384\">Ako predajcovia zabezpe\u010dujeme:<\/p>\n<p data-start=\"2386\" data-end=\"2645\">\u2022 kompletn\u00e9 CE certifik\u00e1cie pre non-medical devices<br data-start=\"2437\" data-end=\"2440\" \/>\u2022 prehl\u00e1senie o zhode<br data-start=\"2461\" data-end=\"2464\" \/>\u2022 bezpe\u010dnostn\u00e9 a technick\u00e9 listy<br data-start=\"2496\" data-end=\"2499\" \/>\u2022 n\u00e1vody na pou\u017eitie<br data-start=\"2519\" data-end=\"2522\" \/>\u2022 detailn\u00e9 protokoly a parametre<br data-start=\"2554\" data-end=\"2557\" \/>\u2022 ozna\u010denie energetick\u00fdch limitov a h\u013abok z\u00e1sahu<br data-start=\"2605\" data-end=\"2608\" \/>\u2022 dokument\u00e1ciu pre kontroln\u00e9 org\u00e1ny<\/p>\n<h3 data-start=\"2648\" data-end=\"2673\">\u00a0<\/h3>\n<h4 data-start=\"2648\" data-end=\"2673\">Borderline zariadenia<\/h4>\n<p data-start=\"2675\" data-end=\"2823\">Niektor\u00e9 technol\u00f3gie (najm\u00e4 microneedling, frak\u010dn\u00e9 technol\u00f3gie, ur\u010dit\u00e9 laserov\u00e9 a HF syst\u00e9my) sa nach\u00e1dzaj\u00fa na hranici medzi kozmetikou a medic\u00ednou.<\/p>\n<p data-start=\"2825\" data-end=\"2855\">MDR stanovuje, \u017ee ak pr\u00edstroj:<\/p>\n<p data-start=\"2857\" data-end=\"2979\">\u2022 p\u00f4sob\u00ed invaz\u00edvne<br data-start=\"2875\" data-end=\"2878\" \/>\u2022 prekra\u010duje z\u00f3nu epidermis<br data-start=\"2905\" data-end=\"2908\" \/>\u2022 sp\u00f4sobuje poru\u0161enie integrity ko\u017ee<br data-start=\"2944\" data-end=\"2947\" \/>\u2022 alebo m\u00e1 fyziologick\u00fd \u00fa\u010dinok<\/p>\n<p data-start=\"2981\" data-end=\"3007\">ide u\u017e o medic\u00ednsky z\u00e1sah.<\/p>\n<p data-start=\"3009\" data-end=\"3101\">V takom pr\u00edpade mus\u00ed ma\u0165 zariadenie medic\u00ednsku klasifik\u00e1ciu a kozmeti\u010dka ho nesmie pou\u017e\u00edva\u0165.<\/p>\n<h3 data-start=\"3104\" data-end=\"3168\">\u00a0<\/h3>\n<h4 data-start=\"3104\" data-end=\"3168\">Pre\u010do je d\u00f4le\u017eit\u00e9 pracova\u0165 len s certifikovan\u00fdmi pr\u00edstrojmi?<\/h4>\n<p data-start=\"3170\" data-end=\"3467\">\u2022 kontroln\u00e9 org\u00e1ny (SOI, \u0160\u00daKL) m\u00f4\u017eu vy\u017eadova\u0165 dokument\u00e1ciu<br data-start=\"3228\" data-end=\"3231\" \/>\u2022 pokuty za nespr\u00e1vne klasifikovan\u00e9 alebo necertifikovan\u00e9 pr\u00edstroje s\u00fa vysok\u00e9<br data-start=\"3308\" data-end=\"3311\" \/>\u2022 spr\u00e1vna dokument\u00e1cia chr\u00e1ni v\u00e1s aj klientky<br data-start=\"3356\" data-end=\"3359\" \/>\u2022 certifikovan\u00e9 pr\u00edstroje s\u00fa bezpe\u010dnej\u0161ie a stabiln\u00e9<br data-start=\"3411\" data-end=\"3414\" \/>\u2022 zaru\u010duj\u00fa profesion\u00e1lne v\u00fdsledky a kvalitu slu\u017eieb<\/p>\n<h3 data-start=\"3470\" data-end=\"3527\">\u00a0<\/h3>\n<h4 data-start=\"3470\" data-end=\"3527\">\u010co zabezpe\u010dujeme my ako predajcovia beauty pr\u00edstrojov<\/h4>\n<p data-start=\"3529\" data-end=\"3598\">Ka\u017ed\u00fd pr\u00edstroj dod\u00e1vame s kompletnou MDR bezpe\u010dnostnou dokument\u00e1ciou:<\/p>\n<p data-start=\"3600\" data-end=\"3866\">\u2022 CE certifik\u00e1t<br data-start=\"3615\" data-end=\"3618\" \/>\u2022 prehl\u00e1senie o zhode<br data-start=\"3639\" data-end=\"3642\" \/>\u2022 technick\u00fd list<br data-start=\"3658\" data-end=\"3661\" \/>\u2022 bezpe\u010dnostn\u00e9 protokoly<br data-start=\"3685\" data-end=\"3688\" \/>\u2022 detailn\u00e9 parametre a limity pou\u017eitia<br data-start=\"3726\" data-end=\"3729\" \/>\u2022 z\u00e1znam o kategoriz\u00e1cii pod\u013ea MDR (medical \/ non-medical)<br data-start=\"3787\" data-end=\"3790\" \/>\u2022 servisn\u00e9 a z\u00e1ru\u010dn\u00e9 dokumenty<br data-start=\"3820\" data-end=\"3823\" \/>\u2022 n\u00e1vod pre spr\u00e1vne a bezpe\u010dn\u00e9 pou\u017e\u00edvanie<\/p>\n<p data-start=\"3868\" data-end=\"3996\">K pr\u00edstrojom poskytujeme aj za\u0161kolenie a odborn\u00fa podporu, aby kozmeti\u010dka pracovala maxim\u00e1lne bezpe\u010dne a v s\u00falade s legislat\u00edvou.<\/p>\n<h4 data-start=\"3999\" data-end=\"4008\">\u00a0<\/h4>\n<h4 data-start=\"3999\" data-end=\"4008\">Z\u00e1ver<\/h4>\n<p data-start=\"4010\" data-end=\"4209\">MDR nie je komplik\u00e1cia, ale d\u00f4le\u017eit\u00fd syst\u00e9m, ktor\u00fd jasne odde\u013euje profesion\u00e1lnu estetick\u00fa prax od medic\u00edny. Kozmeti\u010dky tak presne vedia, ak\u00e9 pr\u00edstroje m\u00f4\u017eu pou\u017e\u00edva\u0165 a v ak\u00fdch parametroch s\u00fa bezpe\u010dn\u00e9.<\/p>\n<p data-start=\"4211\" data-end=\"4324\">Ako predajcovia prin\u00e1\u0161ame iba certifikovan\u00e9 zariadenia, ktor\u00e9 sp\u013a\u0148aj\u00fa v\u0161etky technick\u00e9 a legislat\u00edvne po\u017eiadavky.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Eur\u00f3pska legislat\u00edva v oblasti estetick\u00fdch technol\u00f3gi\u00ed pre\u0161la v posledn\u00fdch rokoch v\u00fdraznou zmenou. Nariadenie MDR (Medical Device Regulation 2017\/745) ur\u010duje jasn\u00e9 pravidl\u00e1 pre pr\u00edstroje pou\u017e\u00edvan\u00e9 v kozmetike, estetike aj medic\u00edne. Pre sal\u00f3ny je k\u013e\u00fa\u010dov\u00e9 rozumie\u0165 rozdielu medzi zdravotn\u00edckou pom\u00f4ckou a pr\u00edstrojom bez medic\u00ednskeho \u00fa\u010delu, aby pracovali v s\u00falade so z\u00e1konom a chr\u00e1nili klientov aj seba. Ako [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2110,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2733","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nezaradene"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR regul\u00e1cia a povinnosti pri pou\u017e\u00edvan\u00ed beauty pr\u00edstrojov - Beauty pr\u00edstroje<\/title>\n<meta name=\"description\" content=\"Preh\u013ead MDR regul\u00e1cie a povinnost\u00ed pri pou\u017e\u00edvan\u00ed beauty pr\u00edstrojov. 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