{"id":31537,"date":"2026-02-13T09:42:15","date_gmt":"2026-02-13T12:42:15","guid":{"rendered":"https:\/\/sobelconsult.com\/mdr-and-ivdr-under-review\/"},"modified":"2026-02-13T09:42:52","modified_gmt":"2026-02-13T12:42:52","slug":"mdr-and-ivdr-under-review","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/","title":{"rendered":"Nouvelles : MDR et IVDR en cours de r\u00e9vision, QMSR en vigueur, etc."},"content":{"rendered":"\n

Au cours des derniers mois, le secteur de la r\u00e9glementation s’est de plus en plus concentr\u00e9 sur des sujets li\u00e9s au MDR et \u00e0 l’IVDR.<\/p>\n\n

Dans la derni\u00e8re \u00e9dition de Sobel News, nous avons couvert une \u00e9tude command\u00e9e par l’Union europ\u00e9enne qui analyse l’impact du MDR et de l’IVDR<\/a> sur le march\u00e9 des dispositifs m\u00e9dicaux dans la r\u00e9gion.<\/p>\n\n

Fin janvier, Bruxelles a accueilli des discussions sur les r\u00e9visions potentielles du MDR et de l’IVDR<\/strong>.<\/p>\n\n

Cette mise \u00e0 jour, ainsi que d’importants d\u00e9veloppements r\u00e9glementaires aux \u00c9tats-Unis et en Chine, font l’objet du pr\u00e9sent article.<\/p>\n\n

Le MDR et l’IVDR en cours de r\u00e9vision dans l’Union europ\u00e9enne<\/strong><\/h2>\n\n

Les autorit\u00e9s r\u00e9glementaires de l’Union europ\u00e9enne ont pr\u00e9sent\u00e9 des propositions initiales de r\u00e9vision du MDR et de l’IVDR<\/strong><\/a> (Medical Device Regulation et In Vitro Diagnostic Regulation).<\/p>\n\n

L’objectif est d’adapter les op\u00e9rations r\u00e9glementaires afin de r\u00e9duire les difficult\u00e9s rencontr\u00e9es par les fabricants au cours des processus de certification et de maintenance.<\/p>\n\n

Les discussions portent notamment sur l’am\u00e9lioration de la pr\u00e9visibilit\u00e9 r\u00e9glementaire et sur la possibilit\u00e9 de prolonger les d\u00e9lais dans des situations sp\u00e9cifiques. Elles portent \u00e9galement sur les ajustements des exigences affectant la disponibilit\u00e9 des produits sur le march\u00e9 europ\u00e9en. <\/p>\n\n

Depuis leur mise en \u0153uvre, le MDR et l’IVDR ont consid\u00e9rablement accru les exigences techniques et documentaires impos\u00e9es aux fabricants, renfor\u00e7ant ainsi les normes de s\u00e9curit\u00e9 et de performance.<\/p>\n\n

Toutefois, ce cadre a pos\u00e9 des probl\u00e8mes, notamment l’augmentation des co\u00fbts r\u00e9glementaires, la complexit\u00e9 des processus et la capacit\u00e9 limit\u00e9e des organismes notifi\u00e9s.<\/p>\n\n

Fondamentalement, les r\u00e9visions propos\u00e9es visent \u00e0 am\u00e9liorer l’efficacit\u00e9 de la r\u00e9glementation sans compromettre les objectifs fondamentaux.<\/p>\n\n

Pour les fabricants, les changements apport\u00e9s au MDR et \u00e0 l’IVDR peuvent avoir une incidence sur la planification r\u00e9glementaire, les priorit\u00e9s du march\u00e9 et les calendriers du cycle de vie des produits.<\/p>\n\n

Il s’agit d’un sujet qui devrait rester d’actualit\u00e9 dans les mois \u00e0 venir.<\/p>\n\n

Entr\u00e9e en vigueur<\/strong>du QMSR<\/strong>aux \u00c9tats-Unis<\/strong><\/h2>\n\n

Le nouveau r\u00e8glement sur le syst\u00e8me de gestion de la qualit\u00e9 de la FDA est entr\u00e9 en vigueur. Le nouveau r\u00e8glement de la FDA sur les syst\u00e8mes de gestion de la qualit\u00e9 (QMSR) est entr\u00e9 en vigueur,<\/strong><\/a> alignant les exigences du syst\u00e8me de qualit\u00e9 des dispositifs m\u00e9dicaux sur la norme ISO 13485.<\/p>\n\n

Cette mise \u00e0 jour repr\u00e9sente une \u00e9tape importante vers l’harmonisation des r\u00e9glementations au niveau international.<\/p>\n\n

Dans la pratique, elle introduit des ajustements pertinents aux attentes en mati\u00e8re de conformit\u00e9 pour les fabricants op\u00e9rant sur le march\u00e9 am\u00e9ricain, ce qui n\u00e9cessite <\/strong>des mises \u00e0 jour des proc\u00e9dures internes, de la documentation et des processus d’audit.<\/strong><\/a><\/p>\n\n

\"Mains<\/figure>\n\n

La Chine lance un plan de renforcement des syst\u00e8mes de qualit\u00e9 dans l’industrie des cosm\u00e9tiques<\/strong><\/h2>\n\n

Les autorit\u00e9s r\u00e9glementaires chinoises ont annonc\u00e9 un plan d’action 2026-2028<\/a> visant \u00e0 renforcer les syst\u00e8mes de qualit\u00e9 pour les fabricants de cosm\u00e9tiques.<\/strong><\/p>\n\n

L’initiative comprend une supervision renforc\u00e9e bas\u00e9e sur le risque, un contr\u00f4le plus strict des mati\u00e8res premi\u00e8res et une surveillance continue de la conformit\u00e9 tout au long du cycle de vie du produit.<\/p>\n\n

Il s’agit l\u00e0 d’un signal clair d’une augmentation des attentes en mati\u00e8re de r\u00e9glementation pour les entreprises qui fabriquent ou exportent vers le march\u00e9 chinois.<\/p>\n\n

La FDA publie un projet de lignes directrices pour les cosm\u00e9tiques<\/strong><\/h2>\n\n

La FDA a publi\u00e9 un projet de guide d\u00e9crivant les nouvelles attentes en mati\u00e8re de s\u00e9curit\u00e9 et de r\u00e9glementation<\/strong><\/a> applicables aux produits cosm\u00e9tiques.<\/strong><\/p>\n\n

Le document souligne la n\u00e9cessit\u00e9 d’une documentation technique solide, d’une bonne tenue des registres et d’un renforcement des pratiques de surveillance apr\u00e8s la mise sur le march\u00e9<\/strong>.<\/p>\n\n

Bien qu’encore pr\u00e9liminaires, ces lignes directrices indiquent l’orientation future de la r\u00e9glementation et permettent aux entreprises de commencer \u00e0 ajuster leurs processus de mise en conformit\u00e9.<\/p>\n\n

Qualit\u00e9, tra\u00e7abilit\u00e9 et surveillance r\u00e9glementaire<\/strong><\/h2>\n\n

Les discussions autour du MDR et de l’IVDR, combin\u00e9es \u00e0 la mise en \u0153uvre du QMSR aux \u00c9tats-Unis et aux nouvelles initiatives r\u00e9glementaires en Chine et dans le secteur des cosm\u00e9tiques aux \u00c9tats-Unis, d\u00e9montrent que l’environnement r\u00e9glementaire mondial continue d’\u00e9voluer vers des mod\u00e8les plus solides de qualit\u00e9, de tra\u00e7abilit\u00e9 et de surveillance.<\/p>\n\n

Pour les fabricants et les entreprises actives au niveau international, il est essentiel de suivre ces changements et d’int\u00e9grer la veille r\u00e9glementaire dans la strat\u00e9gie commerciale afin de r\u00e9duire les risques, de maintenir la conformit\u00e9 et de pr\u00e9server la comp\u00e9titivit\u00e9 sur des march\u00e9s de plus en plus exigeants.<\/p>\n\n

Qu’il s’agisse du MDR et de l’IVDR, des tendances r\u00e9glementaires en mati\u00e8re de cosm\u00e9tiques ou des nouvelles publications des autorit\u00e9s r\u00e9glementaires, la lettre d’information Sobel est l’endroit o\u00f9 vous trouverez les mises \u00e0 jour les plus importantes de l’industrie.<\/p>\n\n

Abonnez-vous gratuitement au Sobel News Round Up<\/a> et restez inform\u00e9 des d\u00e9veloppements susceptibles d’avoir un impact sur votre entreprise dans les secteurs des dispositifs m\u00e9dicaux, des DIV et des cosm\u00e9tiques.<\/p>\n\n

Pour \u00e9laborer une strat\u00e9gie r\u00e9glementaire efficace, il faut se pr\u00e9parer aux mises \u00e0 jour constantes de la r\u00e9glementation mondiale.<\/p>\n","protected":false},"excerpt":{"rendered":"

Mises \u00e0 jour mondiales sur le MDR et l’IVDR, le QMSR aux \u00c9tats-Unis et les nouvelles exigences r\u00e9glementaires pour les cosm\u00e9tiques en Chine et sur le march\u00e9 am\u00e9ricain.<\/p>\n","protected":false},"author":16,"featured_media":31526,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[314],"tags":[315,295,327,115,136,85,117],"class_list":["post-31537","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites","tag-actualites","tag-brazil","tag-china","tag-cosmetiques","tag-dispositifs-medicaux","tag-fda","tag-leurope"],"yoast_head":"\nNouvelles : MDR et IVDR en cours de r\u00e9vision, QMSR en vigueur, etc. - Sobel<\/title>\n<meta name=\"description\" content=\"Mises \u00e0 jour mondiales sur le MDR et l'IVDR, le QMSR aux \u00c9tats-Unis et les nouvelles exigences r\u00e9glementaires pour les cosm\u00e9tiques en Chine et sur le march\u00e9 am\u00e9ricain.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nouvelles : MDR et IVDR en cours de r\u00e9vision, QMSR en vigueur, etc.\" \/>\n<meta property=\"og:description\" content=\"Mises \u00e0 jour mondiales sur le MDR et l'IVDR, le QMSR aux \u00c9tats-Unis et les nouvelles exigences r\u00e9glementaires pour les cosm\u00e9tiques en Chine et sur le march\u00e9 am\u00e9ricain.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-13T12:42:15+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-13T12:42:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/02\/Rear-view-of-female-business-executive-giving-a-speech.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1500\" \/>\n\t<meta property=\"og:image:height\" content=\"1000\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Bruna Marzarotto\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Bruna Marzarotto\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"Nouvelles : MDR et IVDR en cours de r\u00e9vision, QMSR en vigueur, etc.\",\"datePublished\":\"2026-02-13T12:42:15+00:00\",\"dateModified\":\"2026-02-13T12:42:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/\"},\"wordCount\":949,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/02\/Rear-view-of-female-business-executive-giving-a-speech.webp\",\"keywords\":[\"Actualit\u00e9s\",\"Brazil\",\"China\",\"Cosm\u00e9tiques\",\"Dispositifs m\u00e9dicaux\",\"FDA\",\"L'Europe\"],\"articleSection\":[\"Actualit\u00e9s\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/\",\"url\":\"https:\/\/sobelconsult.com\/fr\/mdr-and-ivdr-under-review\/\",\"name\":\"Nouvelles : MDR et IVDR en cours de r\u00e9vision, QMSR en vigueur, etc. - 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