{"id":8453,"date":"2025-11-26T23:07:57","date_gmt":"2025-11-26T23:07:57","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8453"},"modified":"2025-11-26T23:07:57","modified_gmt":"2025-11-26T23:07:57","slug":"lors-de-lachat-dune-machine-de-traitement-par-ondes-de-choc-doit-elle-etre-conforme-au-reglement-europeen-sur-la-recuperation-des-emballages","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/fr\/when-purchasing-a-shockwave-therapy-machine-must-it-comply-with-the-eu-packaging-recovery-regulation\/","title":{"rendered":"Lors de l'achat d'une machine de th\u00e9rapie par ondes de choc, doit-elle \u00eatre conforme \u00e0 la r\u00e9glementation europ\u00e9enne sur la r\u00e9cup\u00e9ration des emballages ?"},"content":{"rendered":"

\n \"Configuration\n<\/p>\n

De notre point de vue, c\u00f4t\u00e9 production, nous constatons souvent que les acheteurs ne savent pas si les appareils de th\u00e9rapie par ondes de choc doivent se conformer au r\u00e8glement mis \u00e0 jour de l'UE sur les emballages et les d\u00e9chets d'emballages lorsqu'ils entrent sur le march\u00e9 de l'UE.<\/p>\n

Oui, les appareils de th\u00e9rapie par ondes de choc doivent se conformer au r\u00e8glement de l'UE sur les emballages et les d\u00e9chets d'emballages, car tous les emballages mis sur le march\u00e9 de l'UE \u2013 quelle que soit la cat\u00e9gorie de produit \u2013 rel\u00e8vent de la responsabilit\u00e9 \u00e9largie des producteurs (REP), des exigences de recyclage et de l'\u00e9tiquetage harmonis\u00e9, sauf exemptions sp\u00e9cifiques pour des raisons de st\u00e9rilit\u00e9 ou d'int\u00e9grit\u00e9 du produit.<\/strong><\/p>\n

Comprendre ces r\u00e8gles \u00e0 l'avance permet d'\u00e9viter les probl\u00e8mes douaniers, les retards de d\u00e9douanement et les co\u00fbts de conformit\u00e9 impr\u00e9vus pour les importateurs.<\/p>\n

Lorsque vous planifiez \u00e0 l'avance, la conformit\u00e9 des emballages devient une partie pr\u00e9visible de votre cha\u00eene d'approvisionnement au lieu d'une surprise r\u00e9glementaire.<\/p>\n

\n

Quelles normes d'emballage sont requises pour la conformit\u00e9 environnementale ?<\/h2>\n

Du point de vue d'un fabricant, nous travaillons fr\u00e9quemment avec des distributeurs de l'UE qui comptent sur nous pour concevoir des emballages qui r\u00e9pondent aux obligations de recyclabilit\u00e9, de marquage et de documentation en vertu des derni\u00e8res r\u00e8gles de l'UE.<\/p>\n

Les emballages des appareils de th\u00e9rapie par ondes de choc doivent respecter les exigences de l'UE en mati\u00e8re de recyclabilit\u00e9 des mat\u00e9riaux, d'\u00e9tiquettes harmonis\u00e9es, d'identification pr\u00e9cise des mat\u00e9riaux, d'enregistrement REP et de rapports appropri\u00e9s \u2013 m\u00eame si certains emballages de dispositifs m\u00e9dicaux sont exempt\u00e9s des objectifs de contenu recycl\u00e9 ou de recyclabilit\u00e9 pour des raisons de s\u00e9curit\u00e9.<\/strong><\/p>\n

\"Techniciens<\/p>\n

Le r\u00e8glement de l'UE sur les emballages et les d\u00e9chets d'emballages (PPWR) s'applique largement aux emballages mis sur le march\u00e9, comme d\u00e9crit dans le r\u00e9sum\u00e9 officiel de la proposition PPWR<\/a><\/strong> 1<\/a><\/sup>.<\/p>\n

1. Exigences de recyclabilit\u00e9<\/h3>\n

La plupart des emballages vendus dans l'UE doivent \u00eatre con\u00e7us pour \u00eatre recyclables. Les crit\u00e8res de recyclabilit\u00e9 font r\u00e9f\u00e9rence aux principes d\u00e9finis dans les directives europ\u00e9ennes sur les emballages de l'\u00e9conomie circulaire<\/a><\/strong> 2<\/a><\/sup>.<\/p>\n

2. Exigences en mati\u00e8re de contenu recycl\u00e9<\/h3>\n

Les seuils futurs obligatoires de contenu recycl\u00e9 suivent les objectifs \u00e9nonc\u00e9s dans les documents de politique de l'UE sur les emballages en plastique<\/a><\/strong> 3<\/a><\/sup>.<\/p>\n

3. \u00c9tiquetage harmonis\u00e9<\/h3>\n

Les formats d'\u00e9tiquettes, les identifiants de mat\u00e9riaux et les r\u00e8gles de marquage d'\u00e9limination correspondent aux normes europ\u00e9ennes harmonis\u00e9es d'\u00e9tiquetage des emballages<\/a><\/strong> 4<\/a><\/sup>.<\/p>\n

4. Minimisation des emballages<\/h3>\n

Les exigences de minimisation, y compris les ratios de vide, sont r\u00e9f\u00e9renc\u00e9es dans les principes europ\u00e9ens de pr\u00e9vention des d\u00e9chets d'emballages<\/a><\/strong> 5<\/a><\/sup>.<\/p>\n

Tableau des normes d'emballage<\/h3>\n\n\n\n\n\n\n\n\n\n
Type d'exigence<\/th>\nDescription<\/th>\nS'applique aux emballages Shockwave ?<\/th>\n<\/tr>\n<\/thead>\n
Recyclabilit\u00e9<\/td>\nDoit \u00eatre recyclable par conception<\/td>\nOui (sauf exemption de st\u00e9rilit\u00e9)<\/td>\n<\/tr>\n
Teneur recycl\u00e9e<\/td>\nObligatoire % pour les plastiques<\/td>\nPartiellement (exempt si st\u00e9rilit\u00e9)<\/td>\n<\/tr>\n
Labeling<\/td>\nMarques de recyclage harmonis\u00e9es<\/td>\nOui<\/td>\n<\/tr>\n
Enregistrement REP<\/td>\nResponsabilit\u00e9 au niveau du pays<\/td>\nOui<\/td>\n<\/tr>\n
Minimisation des emballages<\/td>\n\u00c9viter les emballages excessifs<\/td>\nOui<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

Les dispositifs m\u00e9dicaux et esth\u00e9tiques sont-ils soumis aux m\u00eames r\u00e8gles d'emballage ?<\/h2>\n

Les dispositifs m\u00e9dicaux et esth\u00e9tiques suivent le m\u00eame cadre europ\u00e9en d'emballage, mais les emballages m\u00e9dicaux st\u00e9riles ou sensibles \u00e0 la contamination peuvent \u00eatre exempt\u00e9s de certaines obligations de recyclabilit\u00e9 et de contenu recycl\u00e9, tandis que les dispositifs esth\u00e9tiques doivent suivre les exigences compl\u00e8tes en mati\u00e8re d'emballage sans exemptions.<\/strong><\/p>\n

\"Kits<\/p>\n

Le traitement des emballages pour les biens li\u00e9s au domaine m\u00e9dical suit les d\u00e9finitions de Interpr\u00e9tations r\u00e9glementaires europ\u00e9ennes des emballages m\u00e9dicaux<\/a><\/strong> 6<\/a><\/sup>.<\/p>\n

Cat\u00e9gories d'emballages de dispositifs m\u00e9dicaux<\/h3>\n

Le droit de l'UE distingue entre :<\/p>\n

    \n
  1. Emballage barri\u00e8re st\u00e9rile<\/strong> <\/li>\n
  2. \u00c9lectronique m\u00e9dicale non st\u00e9rile<\/strong> (machines \u00e0 ondes de choc) <\/li>\n
  3. Dispositifs esth\u00e9tiques ou de bien-\u00eatre<\/strong> <\/li>\n<\/ol>\n

    Les machines de th\u00e9rapie par ondes de choc rel\u00e8vent de \u00e9lectronique m\u00e9dicale non st\u00e9rile<\/strong>, donc soumis aux r\u00e8gles REP et de recyclabilit\u00e9.<\/p>\n

    Tableau comparatif<\/h3>\n\n\n\n\n\n\n\n
    Type d'appareil<\/th>\nExigence de st\u00e9rilit\u00e9<\/th>\nExemptions de recyclabilit\u00e9<\/th>\nObligations REP compl\u00e8tes ?<\/th>\n<\/tr>\n<\/thead>\n
    Machine de th\u00e9rapie par ondes de choc<\/td>\nNon st\u00e9rile<\/td>\nNon<\/td>\nOui<\/td>\n<\/tr>\n
    Outils chirurgicaux (st\u00e9riles)<\/td>\nEmballage st\u00e9rile<\/td>\nOui<\/td>\nOui<\/td>\n<\/tr>\n
    Appareils de beaut\u00e9\/esth\u00e9tique<\/td>\nNon st\u00e9rile<\/td>\nNon<\/td>\nOui<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    Quelle documentation les fournisseurs doivent-ils fournir pour la conformit\u00e9 des emballages ?<\/h2>\n

    Comme nous pr\u00e9parons des dossiers de conformit\u00e9 pour de nombreux clients europ\u00e9ens, nous savons que les acheteurs ont souvent du mal \u00e0 identifier les documents d'emballage l\u00e9galement requis.<\/p>\n

    Les fournisseurs font couramment r\u00e9f\u00e9rence aux exigences de conformit\u00e9 des emballages de l'UE<\/a><\/strong> 7<\/a><\/sup> lors de la pr\u00e9paration de la documentation.<\/p>\n

    \"Dossier<\/p>\n

    Les documents requis comprennent :<\/h3>\n
      \n
    1. \n

      Certificat d'enregistrement REP<\/strong>
      \nLes obligations REP suivent les exigences nationales souvent accessibles via       les directives de conformit\u00e9 REP de l'UE<\/a><\/strong> 8<\/a><\/sup>.<\/p>\n<\/li>\n

    2. \n

      Liste de composition des mat\u00e9riaux d'emballage<\/strong> <\/p>\n<\/li>\n

    3. \n

      \u00c9valuation de la recyclabilit\u00e9<\/strong> <\/p>\n<\/li>\n

    4. \n

      D\u00e9claration de conformit\u00e9 des emballages<\/strong> <\/p>\n<\/li>\n

    5. \n

      Feuille de v\u00e9rification de l'\u00e9tiquetage<\/strong> <\/p>\n<\/li>\n<\/ol>\n

      Tableau de documentation<\/h3>\n\n\n\n\n\n\n\n\n\n
      Type de document<\/th>\nObjectif<\/th>\nN\u00e9cessaire ?<\/th>\n<\/tr>\n<\/thead>\n
      Preuve d'enregistrement REP<\/td>\nConfirme la conformit\u00e9 dans le pays du march\u00e9 cible<\/td>\nOui<\/td>\n<\/tr>\n
      Liste de la composition des mat\u00e9riaux<\/td>\nAssure la transparence de la recyclabilit\u00e9<\/td>\nOui<\/td>\n<\/tr>\n
      D\u00e9claration de recyclabilit\u00e9<\/td>\nConfirme la conformit\u00e9 ou l'exemption<\/td>\nOui<\/td>\n<\/tr>\n
      Feuille d'\u00e9tiquetage<\/td>\nV\u00e9rifie les marques correctes<\/td>\nOui<\/td>\n<\/tr>\n
      D\u00e9claration de conformit\u00e9 de l'emballage<\/td>\nRequis pour les audits et les inspections<\/td>\nOui<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      Comment les acheteurs doivent-ils g\u00e9rer la responsabilit\u00e9 de l'emballage dans le commerce transfrontalier ?<\/h2>\n

      Les acheteurs doivent d\u00e9finir clairement qui assume la responsabilit\u00e9 REP, v\u00e9rifier les enregistrements REP du fournisseur et s'assurer que la documentation d'emballage est attribu\u00e9e \u00e0 l'importateur ou au fabricant, selon qui met le produit sur le march\u00e9 de l'UE.<\/strong><\/p>\n

      \"Convoyeur<\/p>\n

      Les responsabilit\u00e9s REP sont d\u00e9termin\u00e9es par les r\u00e8gles d\u00e9crites dans Crit\u00e8res de responsabilit\u00e9 \u00e9largie du producteur de l'UE<\/a><\/strong> 9<\/a><\/sup>.<\/p>\n

      Principes cl\u00e9s pour la conformit\u00e9 transfrontali\u00e8re<\/h3>\n
        \n
      1. La responsabilit\u00e9 de la REP incombe \u00e0 l'entit\u00e9 qui met le produit sur le march\u00e9 de l'UE<\/strong> <\/li>\n
      2. Responsabilit\u00e9 de l'importateur en cas d'achat aupr\u00e8s d'un fabricant non-UE<\/strong> <\/li>\n
      3. Les transitaires n'assument pas la REP<\/strong> <\/li>\n
      4. Les plateformes appliquent la REP mais ne remplacent pas les obligations de l'importateur<\/strong><\/li>\n<\/ol>\n

        Les attentes suppl\u00e9mentaires en mati\u00e8re d'acc\u00e8s au march\u00e9 sont r\u00e9sum\u00e9es dans Guide de conformit\u00e9 transfrontali\u00e8re des emballages de l'UE<\/a><\/strong> 10<\/a><\/sup>.<\/p>\n

        Tableau des responsabilit\u00e9s transfrontali\u00e8res<\/h3>\n\n\n\n\n\n\n\n\n
        Sc\u00e9nario<\/th>\nPartie responsable de la REP<\/th>\nNotes<\/th>\n<\/tr>\n<\/thead>\n
        Fabricant non-UE avec entit\u00e9 dans l'UE<\/td>\nFabricant<\/td>\nDoit s'enregistrer sur les march\u00e9s locaux<\/td>\n<\/tr>\n
        Fabricant non-UE sans entit\u00e9 dans l'UE<\/td>\nImportateur<\/td>\nSc\u00e9nario le plus courant<\/td>\n<\/tr>\n
        Distributeur vendant dans l'UE<\/td>\nDistributeur ou producteur<\/td>\nSelon le contrat<\/td>\n<\/tr>\n
        Agent ou transitaire utilis\u00e9<\/td>\nNon responsable<\/td>\nPas de fardeau REP<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
        \n

        Conclusion<\/h2>\n

        Les appareils de th\u00e9rapie par ondes de choc doivent \u00eatre conformes au r\u00e8glement europ\u00e9en sur les emballages et les d\u00e9chets d'emballages, y compris les exigences REP, de recyclabilit\u00e9, d'\u00e9tiquetage et de documentation. Les exemptions m\u00e9dicales sont limit\u00e9es et ne s'appliquent pas aux dispositifs \u00e9lectroniques m\u00e9dicaux non st\u00e9riles, rendant la conformit\u00e9 essentielle pour un acc\u00e8s fluide au march\u00e9 et une durabilit\u00e9 \u00e0 long terme.<\/p>\n

        \n

        Notes de bas de page<\/h2>\n

        1. Aper\u00e7u de la proposition PPWR de l'UE. \ufe0e<\/a><\/span>
        \n2. Orientations de l'UE sur les emballages dans le cadre de l'\u00e9conomie circulaire.         \ufe0e<\/a><\/span>
        \n3. R\u00e9sum\u00e9 de la strat\u00e9gie europ\u00e9enne sur les plastiques.         \ufe0e<\/a><\/span>
        \n4. R\u00e8gles harmonis\u00e9es d'\u00e9tiquetage des emballages.         \ufe0e<\/a><\/span>
        \n5. Principes de l'UE en mati\u00e8re de pr\u00e9vention des d\u00e9chets.         \ufe0e<\/a><\/span>
        \n6. Contexte r\u00e9glementaire des emballages de dispositifs m\u00e9dicaux.         \ufe0e<\/a><\/span>
        \n7. R\u00e8gles officielles de conformit\u00e9 des emballages.         \ufe0e<\/a><\/span>
        \n8. Orientations du syst\u00e8me REP de l'UE.         \ufe0e<\/a><\/span>
        \n9. Crit\u00e8res de responsabilit\u00e9 \u00e9largie du producteur de l'UE.         \ufe0e<\/a><\/span>
        \n10. R\u00e9f\u00e9rence de conformit\u00e9 pour l'acc\u00e8s au march\u00e9 de l'UE.         \ufe0e<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"

        From our position on the production side, we often see buyers uncertain about whether shockwave therapy machines must follow the EU\u2019s updated Packaging and Packaging Waste Regulation when entering the EU market. Yes, shockwave therapy machines must comply with the EU Packaging and Packaging Waste Regulation because all packaging placed on the EU market\u2014regardless of […]<\/p>\n","protected":false},"author":3,"featured_media":8456,"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":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"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":""},"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-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":"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":""},"mobile":{"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":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8453","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"\nWhen purchasing a Shockwave Therapy Machine, must it comply with the EU packaging recovery regulation? - KMSLaser<\/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:\/\/kmslaser.com\/fr\/lors-de-lachat-dune-machine-de-traitement-par-ondes-de-choc-doit-elle-etre-conforme-au-reglement-europeen-sur-la-recuperation-des-emballages\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"When purchasing a Shockwave Therapy Machine, must it comply with the EU packaging recovery regulation?\" \/>\n<meta property=\"og:description\" content=\"From our position on the production side, we often see buyers uncertain about whether shockwave therapy machines must follow the EU\u2019s updated Packaging and Packaging Waste Regulation when entering the EU market. 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