{"id":4014,"date":"2021-11-04T10:24:05","date_gmt":"2021-11-04T09:24:05","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4014"},"modified":"2021-11-04T10:36:11","modified_gmt":"2021-11-04T09:36:11","slug":"nouveau-reglement-a-venir-in-vitro-diagnostic-regulation-ivdr-2022","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/nouveau-reglement-a-venir-in-vitro-diagnostic-regulation-ivdr-2022\/","title":{"rendered":"Nouveau r\u00e8glement \u00e0 venir: In Vitro Diagnostic Regulation (IVDR) 2022"},"content":{"rendered":"

Apr\u00e8s une p\u00e9riode de transition de cinq ans, l’IVDD (In Vitro Diagnostic Directive) sera remplac\u00e9e par l’IVDR (In Vitro Diagnostic Regulation) le 26 mai 2022 et s’appliquera \u00e0 tous les dispositifs de diagnostic in vitro commercialis\u00e9s dans les \u00c9tats membres de l’UE.<\/p>\n

L’IVDR comporte les m\u00eames exigences de base que l’IVDD, mais avec certaines am\u00e9liorations majeures pour moderniser le syst\u00e8me actuel. Par rapport \u00e0 l’IVDD, l’IVDR est plus rigoureux, notamment en ce qui concerne les classes de risque et la surveillance par les organismes notifi\u00e9s.<\/p>\n

Le nouveau r\u00e8glement sur les dispositifs de diagnostic in vitro vise \u00e0 garantir un niveau \u00e9lev\u00e9 et coh\u00e9rent de s\u00e9curit\u00e9 des patients dans tous les \u00c9tats membres de l’UE.<\/p>\n

\"\"<\/p>\n

Alors que la p\u00e9riode de transition de l’IVDR touche \u00e0 sa fin, il est important d’\u00eatre en conformit\u00e9 avec l’IVDR. Contactez<\/a> notre expert aujourd’hui pour en savoir plus sur l’IVDR et sur la fa\u00e7on dont vous pouvez le mettre en \u0153uvre dans votre entreprise.<\/p>\n

Derni\u00e8re mise \u00e0 jour – L’Union europ\u00e9enne a r\u00e9cemment propos\u00e9 de retarder la date limite de la p\u00e9riode de transition vers l’IVDR pour certaines activit\u00e9s en raison du retard pris par le COVID. La proposition va maintenant \u00eatre soumise au Parlement europ\u00e9en et au Conseil pour approbation.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Apr\u00e8s une p\u00e9riode de transition de cinq ans, l’IVDD (In Vitro Diagnostic Directive) sera remplac\u00e9e par l’IVDR (In Vitro Diagnostic Regulation) le 26 mai 2022 et s’appliquera \u00e0 tous les dispositifs de diagnostic in vitro commercialis\u00e9s dans les \u00c9tats membres de l’UE. L’IVDR comporte les m\u00eames exigences de base que l’IVDD, mais avec certaines am\u00e9liorations […]<\/p>\n","protected":false},"author":2,"featured_media":4015,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[135,133,134],"tags":[],"class_list":["post-4014","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-2","category-materiovigilance","category-pharmacovigilance"],"acf":[],"yoast_head":"\nNouveau r\u00e8glement \u00e0 venir: In Vitro Diagnostic Regulation (IVDR) 2022 - Universal Medica<\/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.universalmedica.com\/fr\/nouveau-reglement-a-venir-in-vitro-diagnostic-regulation-ivdr-2022\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nouveau r\u00e8glement \u00e0 venir: In Vitro Diagnostic Regulation (IVDR) 2022 - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"Apr\u00e8s une p\u00e9riode de transition de cinq ans, l’IVDD (In Vitro Diagnostic Directive) sera remplac\u00e9e par l’IVDR (In Vitro Diagnostic Regulation) le 26 mai 2022 et s’appliquera \u00e0 tous les dispositifs de diagnostic in vitro commercialis\u00e9s dans les \u00c9tats membres de l’UE. 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