{"id":6086,"date":"2019-10-16T16:26:34","date_gmt":"2019-10-16T16:26:34","guid":{"rendered":"https:\/\/kolabtree.com\/blog\/?p=6086"},"modified":"2020-05-13T13:49:22","modified_gmt":"2020-05-13T13:49:22","slug":"prepare-your-medical-device-for-eu-mdr-8-trusted-resources","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/prepare-your-medical-device-for-eu-mdr-8-trusted-resources\/","title":{"rendered":"Pr\u00e9parez votre dispositif m\u00e9dical pour le MDR de l'UE : 8 ressources de confiance"},"content":{"rendered":"

Pr\u00e9parer votre dispositif m\u00e9dical<\/a> pour le MDR europ\u00e9en peut \u00eatre un processus complexe. Travaillez avec des Consultants MDR<\/a> sur Kolabtree<\/a> pour obtenir de l'aide pour r\u00e9diger un rapport d'\u00e9valuation clinique et vous assurer que votre dispositif est conforme au r\u00e8glement MDR.\u00a0<\/em><\/span><\/p>\n

Mise \u00e0 jour du 13 mai 2020 : Le RMD de l'UE est maintenant report\u00e9 au 26 mai 2021 \u00e0 la lumi\u00e8re de COVID-19.\u00a0<\/strong><\/p><\/blockquote>\n

Le r\u00e8glement de l'Union europ\u00e9enne sur les dispositifs m\u00e9dicaux (EU MDR) est un nouvel ensemble de r\u00e8gles et de r\u00e8glements qui remplacera l'actuelle directive sur les dispositifs m\u00e9dicaux (MDD). Toute entreprise de dispositifs m\u00e9dicaux souhaitant commercialiser un dispositif sur le march\u00e9 de l'UE doit se conformer au MDR, qui entrera en vigueur le 1er janvier 2010. 26 mai 2021<\/strong>. Pr\u00e9parer votre produit pour le MDR de l'UE peut \u00eatre un processus complexe qui implique de compiler une documentation technique complexe et de faire recertifier vos produits.<\/p>\n

Tous les fabricants de dispositifs m\u00e9dicaux doivent obtenir une \"marque CE\" pour montrer que leur produit est conforme aux exigences de la directive MDD\/MDR. La marque CE est l\u00e9galement requise par toute entreprise qui souhaite vendre un dispositif m\u00e9dical dans l'UE. Pour obtenir le marquage CE, l'entreprise de dispositifs m\u00e9dicaux doit soumettre une demande \u00e0 son organisme notifi\u00e9, un ensemble d'organismes de r\u00e9glementation d\u00e9sign\u00e9s par le gouvernement pour \u00e9valuer la conformit\u00e9 de certains produits.<\/p>\n

Pour obtenir le marquage CE, vous devez d'abord d\u00e9terminer quelles r\u00e8gles du RIM s'appliquent \u00e0 votre produit. Ensuite, effectuez une \u00e9valuation approfondie de votre produit pour vous assurer qu'il r\u00e9pond \u00e0 chacune des directives et qu'il est conforme aux normes r\u00e9glementaires. Une fois que vous avez v\u00e9rifi\u00e9 que les directives sont respect\u00e9es, rassemblez toute la documentation technique requise pour votre produit dans un \"dossier technique\". Celui-ci fournit une vue d'ensemble de votre produit, ainsi que des manuels d'instruction, des proc\u00e9dures de contr\u00f4le de la qualit\u00e9 et un rapport d'\u00e9valuation clinique (CER).<\/p>\n

L'examen d'une CER est l'un des documents les plus importants dont vous aurez besoin pour satisfaire aux exigences du RIM. La CER contient les conclusions des \u00e9valuations cliniques r\u00e9alis\u00e9es sur votre dispositif m\u00e9dical, qui sont effectu\u00e9es r\u00e9guli\u00e8rement tout au long du cycle de vie du produit. Il s'agit de rassembler des donn\u00e9es provenant de la litt\u00e9rature existante, d'essais cliniques, de d\u00e9montrer des preuves de s\u00e9curit\u00e9 et d'efficacit\u00e9, et plus encore. Travailler avec un r\u00e9dacteur expert en CER<\/a> peut vous aider \u00e0 \u00e9conomiser du temps et des efforts et \u00e0 augmenter vos chances d'\u00eatre approuv\u00e9 plus rapidement.\u00a0<\/span><\/p>\n

Bien que l'\u00e9ch\u00e9ance soit proche, la confusion et le manque de clart\u00e9 persistent quant \u00e0 la mani\u00e8re de se mettre en conformit\u00e9 avec le MDR. Voici 8 ressources fiables pour vous aider \u00e0 comprendre les bases du MDR de l'UE afin que vous puissiez planifier vos prochaines \u00e9tapes.\u00a0<\/span><\/p>\n

    \n
  1. Le guide de la Commission europ\u00e9enne sur les nouveaux r\u00e8glements : <\/span>
    \n<\/span>    https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations_en<\/span><\/a><\/li>\n
  2. Le guide de l'UE sur le marquage CE <\/span>
    \n<\/span>    https:\/\/europa.eu\/youreurope\/business\/product-requirements\/labels-markings\/ce-marking\/index_en.htm<\/span><\/a><\/li>\n
  3. Un guide d'introduction au MDR et \u00e0 l'IVDR, pr\u00e9par\u00e9 par la MHRA.\u00a0 <\/span>
    \n<\/span>    https:\/\/www.gov.uk\/guidance\/medical-devices-eu-regulations-for-mdr-and-ivdr<\/a><\/li>\n
  4. Lisez les livres blancs de la BSI, qui donnent un aper\u00e7u de ce qui a chang\u00e9 dans le MDR et comment s'y pr\u00e9parer. <\/span>
    \n<\/span>    https:\/\/www.bsigroup.com\/en-GB\/medical-devices\/resources\/whitepapers\/downloads\/<\/span><\/a><\/li>\n
  5. Lignes directrices de l'Agence europ\u00e9enne des m\u00e9dicaments bas\u00e9es sur les cat\u00e9gories de dispositifs m\u00e9dicaux <\/span>
    \n<\/span>    https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices<\/span><\/a><\/li>\n
  6. Le guide rapide du gourou de Greenlight : \"7 questions sur le MDR ont r\u00e9pondu\" <\/span>
    \n<\/b>    https:\/\/www.greenlight.guru\/blog\/7-questions-about-european-mdr-answered<\/span><\/a><\/li>\n
  7. Vid\u00e9o du professeur Christian Johner expliquant les 5 principaux changements introduits par le RMD<\/span>
    \n<\/span>    https:\/\/www.youtube.com\/watch?v=RN9-IqZAqyM<\/span><\/a><\/li>\n
  8. Transition entre les directives relatives aux dispositifs m\u00e9dicaux (MDD) et le r\u00e8glement sur les dispositifs m\u00e9dicaux (MDR) : Un webinaire gratuit <\/span>
    \n<\/span>    https:\/\/www.youtube.com\/watch?v=KD2PKDYGzOY<\/span><\/a><\/li>\n<\/ol>\n

    Les petites et moyennes entreprises de dispositifs m\u00e9dicaux du monde entier travaillent dur pour mettre \u00e0 jour leur documentation technique, ce qui est la partie la plus longue du processus. Compte tenu du court d\u00e9lai et du haut niveau d'expertise requis pour ce travail, beaucoup d'entre elles ont du mal \u00e0 r\u00e9pondre aux exigences. La plupart de ces entreprises ne peuvent tout simplement pas se permettre de voir leur candidature rejet\u00e9e ou de devoir la retravailler. L'embauche d'un r\u00e9dacteur m\u00e9dical ind\u00e9pendant<\/a> ou un R\u00e9dacteur du rapport d'\u00e9valuation clinique<\/a> peut aider les entreprises \u00e0 r\u00e9unir facilement tout ce dont elles ont besoin pour se conformer au r\u00e8glement europ\u00e9en sur les m\u00e9dicaments (MDR) et \u00e0 acc\u00e9l\u00e9rer le processus de certification de leurs produits avant l'\u00e9ch\u00e9ance imminente.<\/span><\/p>\n

     <\/p>\n

    Experts connexes :<\/p>\n

    Consultants en dispositifs m\u00e9dicaux<\/a>\u00a0|\u00a0R\u00e9dacteur m\u00e9dical ind\u00e9pendant<\/a>\u00a0|\u00a0R\u00e9dacteur ind\u00e9pendant du CER<\/a>\u00a0|\u00a0Consultants MDR de l'UE<\/a>\u00a0|\u00a0Soumissions \u00e0 la FDA<\/a>\u00a0|\u00a0Experts en recherche documentaire<\/a>\u00a0|\u00a0Experts en conformit\u00e9 r\u00e9glementaire<\/a>\u00a0|\u00a0Expert en essais cliniques<\/a>\u00a0|\u00a0R\u00e9dacteurs de textes r\u00e9glementaires<\/a>\u00a0|\u00a0Consultants PMS<\/a>\u00a0|\u00a0Consultants du PMCF<\/a>\u00a0|\u00a0Experts en biostatistique<\/a>\u00a0|\u00a0Expert en d\u00e9veloppement de produits\u00a0<\/a><\/strong><\/p>\n

    \u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"

    Pr\u00e9parer votre dispositif m\u00e9dical pour le MDR de l'UE peut \u00eatre un processus complexe. Travaillez avec des consultants MDR de confiance sur Kolabtree pour obtenir de l'aide pour r\u00e9diger un rapport d'\u00e9valuation clinique et vous assurer que votre dispositif est conforme au MDR. Mise \u00e0 jour du 13 mai 2020 : Le MDR de l'UE est maintenant report\u00e9 au 26 mai 2021 \u00e0 la lumi\u00e8re de COVID-19. La Commission europ\u00e9enne<\/p>\n

    Lire la suite<\/a><\/div>","protected":false},"author":12,"featured_media":6089,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,443,540,433],"tags":[],"acf":[],"yoast_head":"\nPrepare your medical device for EU MDR: 8 trusted resources<\/title>\n<meta name=\"description\" content=\"8 trusted resources and guides to help you prepare your medical device for EU MDR, which will come into effect on 26 May 2020.\" \/>\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.kolabtree.com\/blog\/fr\/prepare-your-medical-device-for-eu-mdr-8-trusted-resources\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prepare your medical device for EU MDR: 8 trusted resources\" \/>\n<meta property=\"og:description\" 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