{"id":1747,"date":"2021-02-17T10:57:19","date_gmt":"2021-02-17T10:57:19","guid":{"rendered":"http:\/\/medicallab.coreco.es\/?p=1538"},"modified":"2026-07-01T15:53:43","modified_gmt":"2026-07-01T15:53:43","slug":"directive-93-42-et-reglement-relatif-aux-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/medicallab.coreco.es\/fr\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/","title":{"rendered":"Directive 93\/42 et r\u00e8glement relatif aux dispositifs m\u00e9dicaux"},"content":{"rendered":"

Dans cet article, nous expliquons comment s'op\u00e8re la transition de la directive 93\/42 vers le r\u00e8glement sur les dispositifs m\u00e9dicaux, ainsi que les nouveaux aspects que ce r\u00e8glement pr\u00e9sente pour les fabricants de r\u00e9frig\u00e9rateurs \u00e0 usage m\u00e9dical. <\/p>\n\n\n\n

Le MDR, plus connu sous son acronyme anglais \u00ab Medical Devices Regulation \u00bb, marquera une avanc\u00e9e en mati\u00e8re de normes de qualit\u00e9 pour tous les dispositifs m\u00e9dicaux qui seront fabriqu\u00e9s en Europe.<\/p>\n\n\n\n

Chez Coreco, nous travaillons d'ores et d\u00e9j\u00e0 pour que, lorsque le nouveau r\u00e8glement entrera en vigueur, nos produits soient conformes aux exigences du MDR et pr\u00eats \u00e0 \u00eatre commercialis\u00e9s imm\u00e9diatement.<\/p>\n\n\n\n

Transition de la directive 93\/42 vers le r\u00e8glement relatif aux dispositifs m\u00e9dicaux (MDR)<\/h2>\n\n\n\n

Le Parlement europ\u00e9en a adopt\u00e9 le nouveau R\u00e8glement sur les dispositifs m\u00e9dicaux (MDR).<\/a> Les fabricants de dispositifs m\u00e9dicaux doivent s'attendre \u00e0 des changements majeurs dans un avenir proche. <\/p>\n\n\n\n

Le nouveau r\u00e8glement de l'UE relatif aux dispositifs m\u00e9dicaux remplace l'actuelle directive relative aux dispositifs m\u00e9dicaux (93\/42\/CEE) et la directive relative aux dispositifs m\u00e9dicaux implantables actifs (90\/385\/CEE).<\/p>\n\n\n\n

P\u00e9riode de transition<\/h4>\n\n\n\n

Le r\u00e8glement europ\u00e9en sur les dispositifs m\u00e9dicaux (MDR) a \u00e9t\u00e9 publi\u00e9 le 5 mai 2017 et est entr\u00e9 en vigueur le 25 mai de la m\u00eame ann\u00e9e. Pour les fabricants de dispositifs m\u00e9dicaux d\u00e9j\u00e0 homologu\u00e9s, une p\u00e9riode de transition de trois ans est pr\u00e9vue, c'est-\u00e0-dire jusqu'au 26 mai 2020 (report\u00e9e au 26 mai 2021), pour se conformer aux exigences du r\u00e8glement. <\/p>\n\n\n\n

Pour certains fabricants, la directive MDR pr\u00e9voit une prolongation de la p\u00e9riode de transition. Dans ce cas, les produits peuvent continuer \u00e0 \u00eatre commercialis\u00e9s jusqu\u2019\u00e0 quatre ans au maximum apr\u00e8s l\u2019entr\u00e9e en vigueur de la directive. Des exigences suppl\u00e9mentaires s\u2019appliquent \u00e0 cette prolongation de la p\u00e9riode de transition.<\/p>\n\n\n\n

Les principaux changements apport\u00e9s par le MDR<\/h2>\n\n\n\n

Le MDR diff\u00e8re consid\u00e9rablement des directives europ\u00e9ennes actuelles relatives aux dispositifs m\u00e9dicaux. Parmi les changements les plus importants, on peut citer :<\/p>\n\n\n\n

- \u00c9largissement du champ d'application<\/h4>\n\n\n\n

Les d\u00e9finitions dans le domaine des dispositifs m\u00e9dicaux seront consid\u00e9rablement \u00e9largies afin d'inclure, par exemple, des produits \u00e0 usage non m\u00e9dical, tels que les lentilles de contact color\u00e9es, ainsi que les implants et les substances \u00e0 usage esth\u00e9tique. <\/p>\n\n\n\n

Les experts s'attendent \u00e0 ce que les dispositifs permettant de pr\u00e9dire et de pr\u00e9voir le risque de maladie entrent \u00e9galement dans le champ d'application du r\u00e8glement.<\/p>\n\n\n\n

- D\u00e9signation d'une personne qualifi\u00e9e<\/h4>\n\n\n\n

Les fabricants de dispositifs m\u00e9dicaux doivent d\u00e9signer au moins une personne au sein de leur organisation, qui sera en dernier ressort responsable de garantir le respect des exigences du nouveau r\u00e8glement relatif aux dispositifs m\u00e9dicaux. <\/p>\n\n\n\n

L'organisation doit d\u00e9montrer que cette personne poss\u00e8de les qualifications sp\u00e9cifiques requises pour les t\u00e2ches en question. Les entreprises dites \u00ab petites \u00bb et \u00ab micro-entreprises \u00bb peuvent \u00eatre soumises \u00e0 des exigences moins strictes.<\/p>\n\n\n\n

- Mise en place du syst\u00e8me de num\u00e9ro unique de produit<\/h4>\n\n\n\n

La proposition de r\u00e8glement sur les dispositifs m\u00e9dicaux impose la mise en place d'un syst\u00e8me d'identification unique des dispositifs (UDI). Cette exigence vise \u00e0 faciliter la tra\u00e7abilit\u00e9 de certains dispositifs au sein de la cha\u00eene d'approvisionnement pour les fabricants et les autorit\u00e9s, permettant ainsi le retrait rapide et efficace des dispositifs m\u00e9dicaux pr\u00e9sentant un risque pour la s\u00e9curit\u00e9. <\/p>\n\n\n\n

Il vise \u00e9galement \u00e0 \u00e9largir la base de donn\u00e9es europ\u00e9enne sur les dispositifs m\u00e9dicaux (EUDAMED), en facilitant l'acc\u00e8s aux informations relatives aux dispositifs m\u00e9dicaux autoris\u00e9s (remarque : le lancement d'EUDAMED a \u00e9t\u00e9 report\u00e9 \u00e0 mai 2022).<\/p>\n\n\n\n

- Une surveillance clinique stricte apr\u00e8s la mise sur le march\u00e9.<\/h4>\n\n\n\n

Le nouveau r\u00e8glement sur les dispositifs m\u00e9dicaux \u00e9largit les comp\u00e9tences des organismes notifi\u00e9s en mati\u00e8re de surveillance clinique post-commercialisation. <\/p>\n\n\n\n

Les audits inopin\u00e9s, les pr\u00e9l\u00e8vements al\u00e9atoires et les essais de produits renforcent le processus de mise en \u0153uvre de la r\u00e9glementation de l'UE et contribuent \u00e0 r\u00e9duire les risques li\u00e9s aux dispositifs m\u00e9dicaux non s\u00fbrs. Pour certaines cat\u00e9gories de dispositifs, les fabricants sont tenus de pr\u00e9senter des rapports annuels sur la s\u00e9curit\u00e9 et les performances de leurs dispositifs.<\/p>\n\n\n\n

-Caract\u00e9ristiques techniques<\/h4>\n\n\n\n

Le MDR vise \u00e0 introduire l'instrument r\u00e9glementaire des \u00ab sp\u00e9cifications communes \u00bb, qui permettra \u00e0 la Commission europ\u00e9enne ou \u00e0 des groupes d'experts de publier des sp\u00e9cifications communes applicables tant aux fabricants qu'aux organismes notifi\u00e9s. Celles-ci s'appliqueront parall\u00e8lement \u00e0 toute norme harmonis\u00e9e existante.<\/p>\n\n\n\n

-Classification des produits en fonction du risque, de la dur\u00e9e d'exposition et du degr\u00e9 d'invasivit\u00e9<\/h4>\n\n\n\n

Conform\u00e9ment au nouveau r\u00e8glement MDR, les fabricants doivent prendre connaissance des nouvelles r\u00e8gles de classification et mettre \u00e0 jour leur documentation technique en cons\u00e9quence. Il convient de noter que les dispositifs m\u00e9dicaux de classe III et les dispositifs implantables sont soumis \u00e0 des exigences cliniques plus strictes. Par cons\u00e9quent, ces dispositifs m\u00e9dicaux sont soumis \u00e0 un m\u00e9canisme de contr\u00f4le des \u00e9valuations de conformit\u00e9 (processus d'examen approfondi).<\/p>\n\n\n\n

-Statistiques rigoureuses pour les dispositifs m\u00e9dicaux de classe III et les dispositifs implantables<\/h4>\n\n\n\n

Les fabricants qui ne disposent pas de donn\u00e9es cliniques suffisantes pour d\u00e9montrer la s\u00e9curit\u00e9 et les performances requises d'un produit donn\u00e9 sont tenus de mener des essais cliniques. En outre, les fabricants doivent collecter et conserver les donn\u00e9es cliniques afin d'\u00e9valuer en permanence les risques potentiels pour la s\u00e9curit\u00e9.<\/p>\n\n\n\n

-\u00c9valuation clinique syst\u00e9matique des dispositifs m\u00e9dicaux des classes IIa et IIb.<\/h4>\n\n\n\n

Les fabricants doivent refaire leur \u00e9valuation clinique. Pour ce faire, il convient de tenir compte de la nouvelle r\u00e9daction du r\u00e8glement relatif \u00e0 l'\u00e9quivalence des produits, ainsi que des circonstances dans lesquelles une \u00e9valuation clinique peut l\u00e9gitimement \u00eatre omise.<\/p>\n\n\n\n

-Sans droits acquis<\/h4>\n\n\n\n

Selon le MDR, tous les dispositifs m\u00e9dicaux actuellement homologu\u00e9s doivent faire l'objet de nouveaux essais et \u00eatre certifi\u00e9s conform\u00e9ment aux nouvelles exigences. <\/p>\n\n\n\n

D\u00e9couvrez Coreco<\/h2>\n\n\n\n

Nous esp\u00e9rons que ce petit article vous aura apport\u00e9 des informations qui vous int\u00e9resseront. <\/p>\n\n\n\n

Si vous avez des questions techniques concernant la r\u00e9glementation ou les produits, n'h\u00e9sitez pas \u00e0 nous contacter via info@coreco.es<\/a><\/p>\n\n\n\n

Si vous souhaitez t\u00e9l\u00e9charger notre catalogue, veuillez Cliquez sur cette ligne<\/a> qui vous m\u00e8nera vers notre zone de t\u00e9l\u00e9chargement<\/p>","protected":false},"excerpt":{"rendered":"

Directive 93\/42 et r\u00e8glement relatif aux dispositifs m\u00e9dicaux<\/p>","protected":false},"author":1,"featured_media":1779,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[9],"tags":[],"class_list":["post-1747","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categoria"],"acf":[],"yoast_head":"\nDirectiva 93\/42 y Reglamento de Dispositivos M\u00e9dicos | Medical Lab<\/title>\n<meta name=\"description\" content=\"Si quiere saber m\u00e1s sobre la transici\u00f3n de Directiva 93\/42 al Reglamento de Dispositivos M\u00e9dicos, en este art\u00edculo hablamos sobre ello\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medicallab.coreco.es\/fr\/directive-93-42-et-reglement-relatif-aux-dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Directiva 93\/42 y Reglamento de Dispositivos M\u00e9dicos\" \/>\n<meta property=\"og:description\" content=\"Si quiere saber m\u00e1s sobre la transici\u00f3n de Directiva 93\/42 al Reglamento de Dispositivos M\u00e9dicos, en este art\u00edculo hablamos sobre ello\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medicallab.coreco.es\/fr\/directive-93-42-et-reglement-relatif-aux-dispositifs-medicaux\/\" \/>\n<meta property=\"og:site_name\" content=\"Medical Lab\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-17T10:57:19+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-01T15:53:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/medical2026.3wstudiopro.com\/wp-content\/uploads\/2026\/07\/Tubos-laboratory-1.jpg_2K_202607011727.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1072\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"jesus\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"jesus\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/\"},\"author\":{\"name\":\"jesus\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#\\\/schema\\\/person\\\/101ce523c59b70675314a1bb9e262938\"},\"headline\":\"Directiva 93\\\/42 y Reglamento de Dispositivos M\u00e9dicos\",\"datePublished\":\"2021-02-17T10:57:19+00:00\",\"dateModified\":\"2026-07-01T15:53:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/\"},\"wordCount\":1032,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/Tubos-laboratory-1.jpg_2K_202607011727.webp\",\"articleSection\":[\"Sin categor\u00eda\"],\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/\",\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/\",\"name\":\"Directiva 93\\\/42 y Reglamento de Dispositivos M\u00e9dicos | Medical Lab\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/Tubos-laboratory-1.jpg_2K_202607011727.webp\",\"datePublished\":\"2021-02-17T10:57:19+00:00\",\"dateModified\":\"2026-07-01T15:53:43+00:00\",\"description\":\"Si quiere saber m\u00e1s sobre la transici\u00f3n de Directiva 93\\\/42 al Reglamento de Dispositivos M\u00e9dicos, en este art\u00edculo hablamos sobre ello\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#primaryimage\",\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/Tubos-laboratory-1.jpg_2K_202607011727.webp\",\"contentUrl\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/Tubos-laboratory-1.jpg_2K_202607011727.webp\",\"width\":1920,\"height\":1072},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/directiva-93-42-y-reglamento-de-dispositivos-medicos\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\\\/\\\/medicallab.coreco.es\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Directiva 93\\\/42 y Reglamento de Dispositivos M\u00e9dicos\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#website\",\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/\",\"name\":\"CORECO Medical Lab\",\"description\":\"Medical Lab\",\"publisher\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#organization\"},\"alternateName\":\"CORECO Medical Lab\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/medicallab.coreco.es\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#organization\",\"name\":\"CORECO Medical Lab\",\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/cropped-FAVICON.webp\",\"contentUrl\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/cropped-FAVICON.webp\",\"width\":512,\"height\":512,\"caption\":\"CORECO Medical Lab\"},\"image\":{\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"description\":\"CORECO es una empresa fundada en 1986 dedicada al desarrollo y fabricaci\u00f3n de equipamiento para el amplio mercado hostelero. A lo largo de su historia, se ha caracterizado por una continua evoluci\u00f3n tecnol\u00f3gica y un gran crecimiento empresarial enfocado en ofrecer opciones eficaces y con garant\u00edas a los clientes m\u00e1s exigentes. Puntos clave de la empresa:Enfoque Ecol\u00f3gico y Eficiente: Sus productos est\u00e1n dise\u00f1ados para tener una gran eficiencia energ\u00e9tica, ser respetuosos con la conservaci\u00f3n del medio ambiente y ayudar al usuario final a reducir los costes de uso y mantenimiento. Calidad Certificada: Cuentan con procesos de fabricaci\u00f3n certificados bajo la norma internacional ISO 14001 y someten sus equipos a estrictos procesos de ensayo acordes a las directivas y regulaciones internacionales. Tecnolog\u00eda Avanzada: En la fabricaci\u00f3n de sus equipos emplean componentes de alto rendimiento, entre los que destacan:Refrigerantes hidrocarburos (R290 y R600a). Gesti\u00f3n electr\u00f3nica para el control de temperatura, descarches y condensaci\u00f3n. Aislamiento de poliuretano de alta densidad (40 Kg\\\/m\u00b3). Compresores, ventiladores de alto rendimiento e iluminaci\u00f3n LED.Puertas de cristal con tratamientos bajo-emisivos y barreras t\u00e9rmicas por gas inerte.\",\"email\":\"info@coreco.es\",\"telephone\":\"+34 957 50 22 75\",\"legalName\":\"CORECO S.A.\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/#\\\/schema\\\/person\\\/101ce523c59b70675314a1bb9e262938\",\"name\":\"jesus\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/litespeed\\\/avatar\\\/653694bef48abce83a847738b36d597a.jpg?ver=1787676785\",\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/litespeed\\\/avatar\\\/653694bef48abce83a847738b36d597a.jpg?ver=1787676785\",\"contentUrl\":\"https:\\\/\\\/medicallab.coreco.es\\\/wp-content\\\/litespeed\\\/avatar\\\/653694bef48abce83a847738b36d597a.jpg?ver=1787676785\",\"caption\":\"jesus\"},\"sameAs\":[\"https:\\\/\\\/medicallab.coreco.es\"],\"url\":\"https:\\\/\\\/medicallab.coreco.es\\\/fr\\\/author\\\/jesus\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Directive 93\/42 et r\u00e8glement relatif aux dispositifs m\u00e9dicaux | Medical Lab","description":"Si vous souhaitez en savoir plus sur la transition de la directive 93\/42 vers le r\u00e8glement relatif aux dispositifs m\u00e9dicaux, nous abordons ce sujet dans cet article","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/medicallab.coreco.es\/fr\/directive-93-42-et-reglement-relatif-aux-dispositifs-medicaux\/","og_locale":"fr_FR","og_type":"article","og_title":"Directiva 93\/42 y Reglamento de Dispositivos M\u00e9dicos","og_description":"Si quiere saber m\u00e1s sobre la transici\u00f3n de Directiva 93\/42 al Reglamento de Dispositivos M\u00e9dicos, en este art\u00edculo hablamos sobre ello","og_url":"https:\/\/medicallab.coreco.es\/fr\/directive-93-42-et-reglement-relatif-aux-dispositifs-medicaux\/","og_site_name":"Medical Lab","article_published_time":"2021-02-17T10:57:19+00:00","article_modified_time":"2026-07-01T15:53:43+00:00","og_image":[{"width":1920,"height":1072,"url":"https:\/\/medical2026.3wstudiopro.com\/wp-content\/uploads\/2026\/07\/Tubos-laboratory-1.jpg_2K_202607011727.webp","type":"image\/webp"}],"author":"jesus","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"jesus","Dur\u00e9e de lecture estim\u00e9e":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#article","isPartOf":{"@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/"},"author":{"name":"jesus","@id":"https:\/\/medicallab.coreco.es\/#\/schema\/person\/101ce523c59b70675314a1bb9e262938"},"headline":"Directiva 93\/42 y Reglamento de Dispositivos M\u00e9dicos","datePublished":"2021-02-17T10:57:19+00:00","dateModified":"2026-07-01T15:53:43+00:00","mainEntityOfPage":{"@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/"},"wordCount":1032,"commentCount":0,"publisher":{"@id":"https:\/\/medicallab.coreco.es\/#organization"},"image":{"@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#primaryimage"},"thumbnailUrl":"https:\/\/medicallab.coreco.es\/wp-content\/uploads\/2026\/07\/Tubos-laboratory-1.jpg_2K_202607011727.webp","articleSection":["Sin categor\u00eda"],"inLanguage":"fr-FR","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/","url":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/","name":"Directive 93\/42 et r\u00e8glement relatif aux dispositifs m\u00e9dicaux | Medical Lab","isPartOf":{"@id":"https:\/\/medicallab.coreco.es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#primaryimage"},"image":{"@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#primaryimage"},"thumbnailUrl":"https:\/\/medicallab.coreco.es\/wp-content\/uploads\/2026\/07\/Tubos-laboratory-1.jpg_2K_202607011727.webp","datePublished":"2021-02-17T10:57:19+00:00","dateModified":"2026-07-01T15:53:43+00:00","description":"Si vous souhaitez en savoir plus sur la transition de la directive 93\/42 vers le r\u00e8glement relatif aux dispositifs m\u00e9dicaux, nous abordons ce sujet dans cet article","breadcrumb":{"@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#primaryimage","url":"https:\/\/medicallab.coreco.es\/wp-content\/uploads\/2026\/07\/Tubos-laboratory-1.jpg_2K_202607011727.webp","contentUrl":"https:\/\/medicallab.coreco.es\/wp-content\/uploads\/2026\/07\/Tubos-laboratory-1.jpg_2K_202607011727.webp","width":1920,"height":1072},{"@type":"BreadcrumbList","@id":"https:\/\/medicallab.coreco.es\/directiva-93-42-y-reglamento-de-dispositivos-medicos\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/medicallab.coreco.es\/"},{"@type":"ListItem","position":2,"name":"Directiva 93\/42 y Reglamento de Dispositivos M\u00e9dicos"}]},{"@type":"WebSite","@id":"https:\/\/medicallab.coreco.es\/#website","url":"https:\/\/medicallab.coreco.es\/","name":"CORECO Medical Lab","description":"Laboratoire m\u00e9dical","publisher":{"@id":"https:\/\/medicallab.coreco.es\/#organization"},"alternateName":"CORECO Medical Lab","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/medicallab.coreco.es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/medicallab.coreco.es\/#organization","name":"CORECO Medical Lab","url":"https:\/\/medicallab.coreco.es\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/medicallab.coreco.es\/#\/schema\/logo\/image\/","url":"https:\/\/medicallab.coreco.es\/wp-content\/uploads\/2026\/03\/cropped-FAVICON.webp","contentUrl":"https:\/\/medicallab.coreco.es\/wp-content\/uploads\/2026\/03\/cropped-FAVICON.webp","width":512,"height":512,"caption":"CORECO Medical Lab"},"image":{"@id":"https:\/\/medicallab.coreco.es\/#\/schema\/logo\/image\/"},"description":"CORECO est une entreprise fond\u00e9e en 1986, sp\u00e9cialis\u00e9e dans le d\u00e9veloppement et la fabrication d'\u00e9quipements destin\u00e9s au vaste march\u00e9 de l'h\u00f4tellerie et de la restauration. Tout au long de son histoire, elle s'est distingu\u00e9e par une \u00e9volution technologique constante et une forte croissance, ax\u00e9es sur l'offre de solutions efficaces et fiables aux clients les plus exigeants. Points forts de l'entreprise : Approche \u00e9cologique et efficace : ses produits sont con\u00e7us pour offrir une grande efficacit\u00e9 \u00e9nerg\u00e9tique, respecter la pr\u00e9servation de l'environnement et aider l'utilisateur final \u00e0 r\u00e9duire ses co\u00fbts d'utilisation et d'entretien. Qualit\u00e9 certifi\u00e9e : ses processus de fabrication sont certifi\u00e9s selon la norme internationale ISO 14001 et ses \u00e9quipements sont soumis \u00e0 des proc\u00e9dures d\u2019essai rigoureuses, conformes aux directives et r\u00e9glementations internationales. Technologie de pointe : lors de la fabrication de ses \u00e9quipements, l\u2019entreprise utilise des composants hautement performants, parmi lesquels : des r\u00e9frig\u00e9rants \u00e0 base d\u2019hydrocarbures (R290 et R600a) ; une gestion \u00e9lectronique pour le contr\u00f4le de la temp\u00e9rature, du d\u00e9givrage et de la condensation ; Isolation en polyur\u00e9thane haute densit\u00e9 (40 kg\/m\u00b3). Compresseurs, ventilateurs haute performance et \u00e9clairage LED. Portes vitr\u00e9es dot\u00e9es de traitements \u00e0 faible \u00e9missivit\u00e9 et de barri\u00e8res thermiques \u00e0 gaz inerte.","email":"info@coreco.es","telephone":"+34 957 50 22 75","legalName":"CORECO S.A."},{"@type":"Person","@id":"https:\/\/medicallab.coreco.es\/#\/schema\/person\/101ce523c59b70675314a1bb9e262938","name":"J\u00e9sus","image":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/medicallab.coreco.es\/wp-content\/litespeed\/avatar\/653694bef48abce83a847738b36d597a.jpg?ver=1787676785","url":"https:\/\/medicallab.coreco.es\/wp-content\/litespeed\/avatar\/653694bef48abce83a847738b36d597a.jpg?ver=1787676785","contentUrl":"https:\/\/medicallab.coreco.es\/wp-content\/litespeed\/avatar\/653694bef48abce83a847738b36d597a.jpg?ver=1787676785","caption":"jesus"},"sameAs":["https:\/\/medicallab.coreco.es"],"url":"https:\/\/medicallab.coreco.es\/fr\/author\/jesus\/"}]}},"_links":{"self":[{"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/posts\/1747","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/comments?post=1747"}],"version-history":[{"count":1,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/posts\/1747\/revisions"}],"predecessor-version":[{"id":1764,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/posts\/1747\/revisions\/1764"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/media\/1779"}],"wp:attachment":[{"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/media?parent=1747"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/categories?post=1747"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medicallab.coreco.es\/fr\/wp-json\/wp\/v2\/tags?post=1747"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}