{"id":1281,"date":"2021-02-05T09:31:06","date_gmt":"2021-02-05T08:31:06","guid":{"rendered":"http:\/\/bionok.proyectosrank.com\/?page_id=1281"},"modified":"2021-02-19T10:56:12","modified_gmt":"2021-02-19T09:56:12","slug":"produits-sans-function-medicale","status":"publish","type":"page","link":"https:\/\/bionok.com\/fr\/produits-sans-function-medicale\/","title":{"rendered":"Produits sans fonction m\u00e9dicale pr\u00e9vue"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row css=&#8221;.vc_custom_1606733631624{margin-top: 55px !important;}&#8221;][vc_column][vc_column_text]<\/p>\n<h1 style=\"text-align: center;\">PRODUITS SANS FONCTION M\u00c9DICALE PR\u00c9VUE<\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=&#8221;2345&#8243; img_size=&#8221;full&#8221; el_id=&#8221;imagedesign&#8221;][vc_column_text]Ces produits sont similaires \u00e0 d&#8217;autres dispositifs m\u00e9dicaux en termes de fonctionnement et de risque associ\u00e9. Son innocuit\u00e9 doit donc \u00eatre \u00e9tudi\u00e9e de la m\u00eame mani\u00e8re. \u00c9tant donn\u00e9 que ces produits n&#8217;ont aucun effet clinique, il est important que leurs performances soient d\u00e9montr\u00e9es lors de leur \u00e9valuation de la conformit\u00e9.<\/p>\n<p>Ces produits n\u00e9cessitent, comme le reste des dispositifs m\u00e9dicaux, une d\u00e9claration de conformit\u00e9 dans laquelle le repr\u00e9sentant indique que le produit r\u00e9pond \u00e0 toutes les exigences qui lui correspondent.<\/p>\n<p>Les entreprises qui fabriquaient jusqu&#8217;\u00e0 pr\u00e9sent ces produits devront se conformer aux exigences du r\u00e8glement sur les produits sanitaires. Cela signifie qu&#8217;ils doivent mettre en \u0153uvre le syst\u00e8me qualit\u00e9 appropri\u00e9 dans leurs usines.<\/p>\n<p>Pour commercialiser leurs produits, les fabricants ou les importateurs peuvent d\u00e9signer un repr\u00e9sentant autoris\u00e9 dans l&#8217;Union europ\u00e9enne.<\/p>\n<p>Les produits suivants sont soumis au MDR:<\/p>\n<ul>\n<li>Lentilles de contact color\u00e9es sans ordonnance et autres produits \u00e0 mettre dans les yeux<\/li>\n<li>Les implants et autres produits destin\u00e9s \u00e0 \u00eatre ins\u00e9r\u00e9s totalement ou partiellement dans le corps humain par des moyens chirurgicalement invasifs afin de modifier l&#8217;anatomie.<\/li>\n<li>Produits de comblement cutan\u00e9 et autres substances, m\u00e9langes ou articles destin\u00e9s \u00e0 \u00eatre utilis\u00e9s pour les produits de comblement du visage ou d&#8217;autres membranes dermiques ou muqueuses.<\/li>\n<li>\u00c9quipement con\u00e7u pour r\u00e9duire, \u00e9liminer ou d\u00e9truire les tissus adipeux.<\/li>\n<li>Machines \u00e0 lumi\u00e8re puls\u00e9e intense pour l&#8217;\u00e9pilation du corps et autres rayonnements \u00e9lectromagn\u00e9tiques de haute intensit\u00e9 (par exemple, lumi\u00e8re infrarouge, visible et ultraviolette), \u00e9quipements \u00e9mettant des \u00e9quipements destin\u00e9s \u00e0 \u00eatre utilis\u00e9s sur le corps humain.<\/li>\n<li>\u00c9quipement de stimulation c\u00e9r\u00e9brale qui applique (sans chirurgie invasive) des courants \u00e9lectriques ou des champs magn\u00e9tiques ou \u00e9lectromagn\u00e9tiques qui p\u00e9n\u00e8trent dans le cr\u00e2ne pour modifier l&#8217;activit\u00e9 neuronale du cerveau.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1606726985955{margin-top: 0px !important;margin-bottom: 25px !important;border-top-width: 6px !important;border-top-color: #807002 !important;}&#8221; el_id=&#8221;contactview&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1601110535248{border-left-width: 3px !important;border-left-color: #00184e !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1613727883866{border-left-width: 3px !important;border-left-color: #00184e !important;}&#8221;]<\/p>\n<h4>Avez-vous des questions?<\/h4>\n<p><strong>+34911371170<\/strong>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_btn title=&#8221;N&#8217;H\u00c9SITEZ PAS \u00c0 NOUS CONTACTER&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;sandy-brown&#8221; size=&#8221;lg&#8221; align=&#8221;right&#8221; el_id=&#8221;buttons&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1606729171993{margin-top: 45px !important;margin-bottom: 75px !important;}&#8221;][vc_column]<ul class=\"clients clearfix \"><li style=\"width:16.667%\"><div class=\"client_wrapper\"><div class=\"gs-wrapper\"><img decoding=\"async\" width=\"135\" height=\"75\" 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class=\"gs-wrapper\"><img loading=\"lazy\" decoding=\"async\" width=\"143\" height=\"75\" src=\"https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?fit=143%2C75&amp;ssl=1\" class=\"scale-with-grid wp-post-image\" alt=\"\" srcset=\"https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?w=600&amp;ssl=1 600w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?resize=300%2C158&amp;ssl=1 300w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?resize=260%2C137&amp;ssl=1 260w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?resize=50%2C26&amp;ssl=1 50w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?resize=143%2C75&amp;ssl=1 143w\" sizes=\"(max-width: 143px) 100vw, 143px\" \/><\/div><\/div><\/li><\/ul>\n[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row css=&#8221;.vc_custom_1606733631624{margin-top: 55px !important;}&#8221;][vc_column][vc_column_text] PRODUITS SANS FONCTION M\u00c9DICALE PR\u00c9VUE [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=&#8221;2345&#8243; img_size=&#8221;full&#8221; el_id=&#8221;imagedesign&#8221;][vc_column_text]Ces produits sont similaires \u00e0 d&#8217;autres dispositifs m\u00e9dicaux en termes de fonctionnement et de<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"nf_dc_page":"","footnotes":""},"class_list":["post-1281","page","type-page","status-publish","hentry","types-medical-device-fr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Produits sans fonction m\u00e9dicale pr\u00e9vue - Bionok<\/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:\/\/bionok.com\/other-medical-purpose\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Produits sans fonction m\u00e9dicale pr\u00e9vue - Bionok\" \/>\n<meta property=\"og:description\" content=\"[vc_row css=&#8221;.vc_custom_1606733631624{margin-top: 55px !important;}&#8221;][vc_column][vc_column_text] PRODUITS SANS FONCTION M\u00c9DICALE PR\u00c9VUE [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=&#8221;2345&#8243; img_size=&#8221;full&#8221; el_id=&#8221;imagedesign&#8221;][vc_column_text]Ces produits sont similaires \u00e0 d&#8217;autres dispositifs m\u00e9dicaux en termes de fonctionnement et de [\u2026]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bionok.com\/other-medical-purpose\/\" \/>\n<meta property=\"og:site_name\" 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