{"id":8386,"date":"2025-11-19T23:35:50","date_gmt":"2025-11-19T23:35:50","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8386"},"modified":"2025-11-19T23:35:50","modified_gmt":"2025-11-19T23:35:50","slug":"al-comprar-una-maquina-de-ondas-de-choque-es-obligatorio-el-cumplimiento-del-reglamento-de-dispositivos-medicos-de-la-ue-mdr-clase-iib-o-iii","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/","title":{"rendered":"Al comprar una m\u00e1quina de terapia de ondas de choque, \u00bfes obligatorio el cumplimiento de la clase IIb o III del Reglamento de Dispositivos M\u00e9dicos (MDR) de la UE?"},"content":{"rendered":"<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg\" alt=\"Dispositivo de onda de choque mostrado junto a iconos de caracter\u00edsticas estilo UE (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Como fabricante, me preguntan esto en casi todas las licitaciones de la UE: \u201c\u00bfEs la Clase IIb o III obligatoria para los sistemas de ondas de choque?\u201d La respuesta real depende del prop\u00f3sito previsto, la entrega de energ\u00eda y <a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/08\/08\/annex-viii\/\">las reglas del Anexo VIII del MDR<\/a> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>\u2014no de una \u00fanica clase general.<\/p>\n<p><strong>La Clase IIb o III del MDR no es autom\u00e1ticamente obligatoria para todos los dispositivos de terapia de ondas de choque. La mayor\u00eda de los sistemas terap\u00e9uticos ESWT caen en la Clase IIa o IIb dependiendo del uso previsto, el acoplamiento de energ\u00eda y el perfil de riesgo. Independientemente de la clase, el cumplimiento del MDR y el marcado CE son obligatorios antes de la comercializaci\u00f3n en la UE.<\/strong><\/p>\n<p>Las siguientes secciones detallan la l\u00f3gica de clasificaci\u00f3n, las expectativas del archivo t\u00e9cnico\/CE, la diligencia debida del importador y c\u00f3mo los sistemas radiales versus los enfocados pueden caer en diferentes clases bajo el marco m\u00e1s amplio de la <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\">Reglamento de Dispositivos M\u00e9dicos de la UE (MDR)<\/a> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup>.<\/p>\n<h2>\u00bfC\u00f3mo se clasifica el equipo de terapia de ondas de choque bajo el marco del MDR?<\/h2>\n<p>La clasificaci\u00f3n se determina por <strong>el prop\u00f3sito previsto<\/strong> and <strong>el riesgo inherente<\/strong>, utilizando las reglas del Anexo VIII del MDR para <a href=\"https:\/\/webgate.ec.europa.eu\/udi-helpdesk\/en\/other-relevant-information\/medical-device-classification.html\">la clasificaci\u00f3n de dispositivos m\u00e9dicos en I, IIa, IIb y III<\/a> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>. Los dispositivos de ondas de choque son equipos terap\u00e9uticos activos no implantables que administran energ\u00eda mec\u00e1nica\/ac\u00fastica a trav\u00e9s de la piel a tejidos humanos.<\/p>\n<p><strong>Bajo el Anexo VIII, la ESWT se clasifica generalmente seg\u00fan la Regla 9 (dispositivos terap\u00e9uticos activos destinados a administrar o intercambiar energ\u00eda) y se apoya en la Regla 11 cuando el software impulsa las declaraciones de rendimiento. En la pr\u00e1ctica, la mayor\u00eda de las ESWT musculoesquel\u00e9ticas\/est\u00e9ticas son de Clase IIa o IIb; los dispositivos de grado litotricia tienden hacia IIb, de acuerdo con <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2021-10\/mdcg_2021-24_en_0.pdf\">la gu\u00eda MDCG 2021-24 sobre clasificaci\u00f3n de dispositivos m\u00e9dicos<\/a> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/2a-scene-showing-multiple-clinical-posters-on-a-wal.jpg\" alt=\"Carteles de cl\u00ednica que promocionan los beneficios de la onda de choque y las aplicaciones de tratamiento (ID#2)\" title=\"Beneficios de la onda de choque\" \/><\/p>\n<h3>Lectura pr\u00e1ctica del Anexo VIII para ESWT<\/h3>\n<ul>\n<li><strong>Regla 9:<\/strong> Dispositivos activos que entregan energ\u00eda. El riesgo aumenta con la magnitud de la energ\u00eda, la profundidad y el potencial de da\u00f1o tisular.  <\/li>\n<li><strong>Duraci\u00f3n e invasividad:<\/strong> La ESWT es no invasiva y de contacto transitorio, pero la densidad de energ\u00eda y el \u00f3rgano diana son importantes.  <\/li>\n<li><strong>Prop\u00f3sito previsto:<\/strong> Alivio del dolor, tendinopat\u00eda, remodelaci\u00f3n de heridas\/d\u00e9rmica o fragmentaci\u00f3n de c\u00e1lculos (similar a la litotricia).  <\/li>\n<\/ul>\n<p>Para equipos de habla china, una <a href=\"https:\/\/www.cn-healthcare.com\/articlewm\/20230721\/content-1581748.html\">descripci\u00f3n general en chino de la clasificaci\u00f3n de riesgos del MDR<\/a> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup> puede ayudar a alinear la documentaci\u00f3n interna con las reglas de la UE.<\/p>\n<h3>Tabla 1 \u2014 Resultados t\u00edpicos del MDR para dispositivos de ondas de choque (ilustrativo, espec\u00edfico del dispositivo)<\/h3>\n<table>\n<thead>\n<tr>\n<th>Uso previsto \/ tecnolog\u00eda<\/th>\n<th>Clase probable<\/th>\n<th>Por qu\u00e9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Alivio del dolor musculoesquel\u00e9tico, tendinopat\u00eda (radial o focal; energ\u00eda no litotricia)<\/td>\n<td>IIa\u2013IIb<\/td>\n<td>Energ\u00eda terap\u00e9utica activa con riesgo sist\u00e9mico limitado<\/td>\n<\/tr>\n<tr>\n<td>Dermatolog\u00eda\/est\u00e9tica (celulitis, remodelaci\u00f3n de cicatrices)<\/td>\n<td>IIa\u2013IIb<\/td>\n<td>Energ\u00eda no invasiva; el riesgo depende de la dosis\/profundidad<\/td>\n<\/tr>\n<tr>\n<td>Terapia de heridas \/ afirmaciones de curaci\u00f3n \u00f3sea<\/td>\n<td>A menudo IIb<\/td>\n<td>Afirmaciones de mayor riesgo; efecto biol\u00f3gico m\u00e1s profundo<\/td>\n<\/tr>\n<tr>\n<td>Alta energ\u00eda enfocada similar a la litotricia para fragmentaci\u00f3n de c\u00e1lculos<\/td>\n<td>IIb<\/td>\n<td>Mayor potencial de da\u00f1o tisular<\/td>\n<\/tr>\n<tr>\n<td>Algoritmos de dosis controlados por software (SaMD independiente que influye en la terapia)<\/td>\n<td>Interacci\u00f3n de la Regla 11<\/td>\n<td>El riesgo del software puede elevar los controles, la misma clase de dispositivo todav\u00eda se aplica<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Punto clave:<\/strong> El <strong>la regla aplicable m\u00e1s estricta<\/strong> rige la clase final. Un fabricante debe justificar la clase con una justificaci\u00f3n formal del Anexo VIII en la documentaci\u00f3n t\u00e9cnica, y muchos utilizan <a href=\"https:\/\/www.compliancegate.com\/medical-device-classes-european-union\/\">gu\u00eda pr\u00e1ctica de clasificaci\u00f3n MDR para fabricantes e importadores de la UE<\/a> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> como punto de partida.<\/p>\n<hr \/>\n<h2>Para los compradores que exportan a la UE, \u00bfqu\u00e9 requisitos de marcado CE\/archivo t\u00e9cnico se aplican a estas clases?<\/h2>\n<p>El marcado CE seg\u00fan el MDR requiere <strong>Organismo Notificado<\/strong> para las clases IIa\/IIb\/III. Los compradores deben esperar un paquete regulatorio completo vinculado al modelo exacto, opciones y accesorios (por ejemplo, piezas de mano, cabezales, cables), informado por <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\">la gu\u00eda respaldada por MDCG y documentos \u00fatiles para la implementaci\u00f3n del MDR<\/a> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup>.<\/p>\n<p><strong>Para ESWT de Clase IIa\/IIb, espere un certificado v\u00e1lido de la UE MDR de un Organismo Notificado, una Declaraci\u00f3n de Conformidad y documentaci\u00f3n t\u00e9cnica completa: lista de verificaci\u00f3n GSPR, gesti\u00f3n de riesgos (ISO 14971), informe de evaluaci\u00f3n cl\u00ednica, plan\/informes PMCF, plan PMS, IFU\/etiquetado y asignaciones UDI registradas en EUDAMED.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-high-end-tabletop-scene-displaying-a-complete-md.jpg\" alt=\"Dispositivo de onda de choque con documentos regulatorios sobre la mesa (ID#3)\" title=\"Papeleo regulatorio\" \/><\/p>\n<h3>Tabla 2 \u2014 Elementos del archivo CE \/ t\u00e9cnico que los compradores deben ver (condensado)<\/h3>\n<table>\n<thead>\n<tr>\n<th>Art\u00edculo<\/th>\n<th>Qu\u00e9 buscar<\/th>\n<th>Notas<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Certificado NB (EU MDR Art. 56)<\/strong><\/td>\n<td>Nombre del Organismo Notificado, n\u00famero NB, alcance lista su modelo exacto y accesorios<\/td>\n<td>Verifique la edici\u00f3n, caducidad y cambios del certificado<\/td>\n<\/tr>\n<tr>\n<td><strong>Declaraci\u00f3n de Conformidad de la UE<\/strong><\/td>\n<td>Referencias MDR, clase del dispositivo, normas (por ejemplo, EN 60601-1\/-1-2)<\/td>\n<td>Firmante legal y fecha actual<\/td>\n<\/tr>\n<tr>\n<td><strong>Lista de verificaci\u00f3n GSPR<\/strong><\/td>\n<td>Trazabilidad del Anexo I a las pruebas y controles de dise\u00f1o<\/td>\n<td>Referencia cruzada con informes<\/td>\n<\/tr>\n<tr>\n<td><strong>Informe de Evaluaci\u00f3n Cl\u00ednica (CER)<\/strong><\/td>\n<td>Literatura y\/o datos cl\u00ednicos que respaldan las afirmaciones<\/td>\n<td>Plan PMCF cuando existan lagunas de evidencia<\/td>\n<\/tr>\n<tr>\n<td><strong>Expediente de Gesti\u00f3n de Riesgos<\/strong><\/td>\n<td>Proceso ISO 14971; peligros vinculados a la verificaci\u00f3n\/validaci\u00f3n<\/td>\n<td>Incluye riesgos de energ\u00eda-dosis<\/td>\n<\/tr>\n<tr>\n<td><strong>PMS\/PSUR<\/strong><\/td>\n<td>Plan PMS; PSUR para cadencia IIa\/IIb<\/td>\n<td>Bucle de retroalimentaci\u00f3n de campo definido<\/td>\n<\/tr>\n<tr>\n<td><strong>IFU\/etiquetado\/UDI<\/strong><\/td>\n<td>Asignaci\u00f3n UDI-DI, s\u00edmbolos, conjunto de idiomas<\/td>\n<td>SRN de EUDAMED del fabricante<\/td>\n<\/tr>\n<tr>\n<td><strong>Pruebas esenciales<\/strong><\/td>\n<td>EN 60601-1, EN 60601-1-2, biocompatibilidad (ISO 10993) cuando sea aplicable<\/td>\n<td>Etiquetado EMC para el entorno de uso<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Ruta de evaluaci\u00f3n de la conformidad:<\/strong> Clase IIa\/IIb t\u00edpicamente utiliza <strong>Anexo IX (SGC + TD)<\/strong> or <strong>Anexo XI<\/strong> variantes; su certificado de la NB debe indicar la ruta.<\/p>\n<hr \/>\n<h2>\u00bfQu\u00e9 pasos de diligencia debida deben tomar los importadores con respecto al cumplimiento del MDR del proveedor?<\/h2>\n<p>Los importadores y distribuidores de la UE tienen obligaciones legales (art\u00edculos 13-14 del MDR). La diligencia debida protege el acceso al mercado y reduce la responsabilidad de acuerdo con <a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/07\/08\/mdr-article-13-general-obligations-of-importers\/\">Art\u00edculo 13 obligaciones generales de los importadores en virtud del MDR<\/a> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>.<\/p>\n<p><strong>Los importadores deben verificar la autenticidad de la certificaci\u00f3n del NB, hacer coincidir las identidades de los modelos, comprobar el UDI\/etiquetado, confirmar los datos del operador econ\u00f3mico y conservar copias del DoC y los certificados. Establecer una v\u00eda de vigilancia para las quejas y las acciones de seguridad en campo, y verificar los registros de EUDAMED y los datos del PRRC, utilizando <a href=\"https:\/\/casusconsulting.com\/eu-importer-requirements-article-13-the-mdr-ivdr\/\">requisitos detallados para importadores y preguntas frecuentes en virtud del Reglamento de la UE sobre productos sanitarios\/productos sanitarios de diagn\u00f3stico in vitro<\/a> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup> como una lista de verificaci\u00f3n pr\u00e1ctica.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/4a-professional-office-scene-showing-an-eu-importer.jpg\" alt=\"Importador revisando archivos de certificaci\u00f3n para dispositivos est\u00e9ticos (ID#4)\" title=\"Revisi\u00f3n de certificaci\u00f3n\" \/><\/p>\n<h3>Tabla 3 \u2014 Lista de verificaci\u00f3n de diligencia debida del importador (copiar\/pegar)<\/h3>\n<table>\n<thead>\n<tr>\n<th>Control<\/th>\n<th>C\u00f3mo verificar<\/th>\n<th>Se\u00f1ales de alerta<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Validez del certificado del NB<\/td>\n<td>Comprobar el n\u00famero del NB; confirmar con el sitio web\/base de datos del NB<\/td>\n<td>El certificado enumera una familia de modelos diferente<\/td>\n<\/tr>\n<tr>\n<td>Declaraci\u00f3n de conformidad<\/td>\n<td>Cotejar n\u00fameros de pieza, opciones, accesorios<\/td>\n<td>Normas faltantes o regulaci\u00f3n incorrecta citada<\/td>\n<\/tr>\n<tr>\n<td>UDI y etiquetado<\/td>\n<td>Verificar UDI-DI y basic UDI-DI; idioma establecido para el EM de destino<\/td>\n<td>UDI no impreso; nombre del dispositivo no coincidente<\/td>\n<\/tr>\n<tr>\n<td>Operadores econ\u00f3micos<\/td>\n<td>Fabricante, Representante Autorizado, Importador identificados con direcciones<\/td>\n<td>RA de la UE faltante; direcciones de shell<\/td>\n<\/tr>\n<tr>\n<td>IFU y reclamaciones<\/td>\n<td>Las reclamaciones se alinean con el alcance de la CER y el certificado<\/td>\n<td>Marketing fuera de etiqueta, reclamaciones est\u00e9ticas no cubiertas<\/td>\n<\/tr>\n<tr>\n<td>PMS \/ vigilancia<\/td>\n<td>SOP del proveedor para quejas, gesti\u00f3n de FSN\/FSCA<\/td>\n<td>No hay proceso documentado ni contactos<\/td>\n<\/tr>\n<tr>\n<td>EUDAMED \/ SRN<\/td>\n<td>El fabricante y el RA tienen SRN; entradas del m\u00f3dulo UDI seg\u00fan corresponda<\/td>\n<td>Sin SRN; \u201cregistro pendiente\u201d durante a\u00f1os<\/td>\n<\/tr>\n<tr>\n<td>Control de configuraci\u00f3n<\/td>\n<td>Opciones\/cabezales\/piezas de mano listados en el certificado<\/td>\n<td>Venta de kits no cubiertos por el alcance<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Mantener un <strong>acuerdo de acceso al dossier t\u00e9cnico<\/strong> para que pueda obtener pruebas espec\u00edficas bajo NDA durante auditor\u00edas o licitaciones.<\/p>\n<hr \/>\n<h2>\u00bfExisten diferencias en la clasificaci\u00f3n\/requisitos entre las m\u00e1quinas de ondas de choque radiales y enfocadas?<\/h2>\n<p>Ambos son <strong>dispositivos de energ\u00eda activos no implantables<\/strong>, pero el acoplamiento de energ\u00eda y el prop\u00f3sito previsto difieren. Los reguladores se centran en el <strong>riesgo<\/strong>, no en la marca; aplican las mismas reglas del Anexo VIII resumidas en <a href=\"https:\/\/reguverse.com\/documentation\/eu-mdr-indexing\/classification\/\">Notas de clasificaci\u00f3n MDR de ReguVerse<\/a> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<p><strong>Los sistemas radiales (ondas de presi\u00f3n m\u00e1s amplias y superficiales) a menudo justifican la Clase IIa para indicaciones musculoesquel\u00e9ticas, mientras que los sistemas enfocados, especialmente con afirmaciones m\u00e1s profundas o similares a la litotricia, caen m\u00e1s com\u00fanmente en la Clase IIb. La clasificaci\u00f3n depende del uso previsto, la densidad de energ\u00eda, la profundidad y la evidencia cl\u00ednica que respalde la seguridad y el rendimiento.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/5a-close-up-of-a-focused-eswt-device-interface-that.jpg\" alt=\"Interfaz de primer plano de un dispositivo ESWT moderno en una cl\u00ednica (ID#5)\" title=\"Interfaz ESWT\" \/><\/p>\n<h3>Tabla 4: Radial vs. enfocado: consideraciones regulatorias (generalizadas)<\/h3>\n<table>\n<thead>\n<tr>\n<th>Aspecto<\/th>\n<th>ESWT Radial<\/th>\n<th>Focused ESWT<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Perfil de energ\u00eda<\/td>\n<td>Energ\u00eda focal m\u00e1s amplia y de menor pico<\/td>\n<td>Mayor energ\u00eda focal, mayor alcance<\/td>\n<\/tr>\n<tr>\n<td>Reclamaciones t\u00edpicas<\/td>\n<td>Alivio del dolor musculoesquel\u00e9tico, tendinopat\u00eda, alisamiento de la celulitis<\/td>\n<td>Musculoesquel\u00e9tico, estimulaci\u00f3n \u00f3sea, tendones dif\u00edciles; algunos sistemas cerca de rangos de litotricia<\/td>\n<\/tr>\n<tr>\n<td>Clase probable (ilustrativa)<\/td>\n<td>IIa \u2192 IIb (risk-based)<\/td>\n<td>IIb more common<\/td>\n<\/tr>\n<tr>\n<td>Evidence burden<\/td>\n<td>Literature + performance equivalence<\/td>\n<td>Stronger CER, PMCF often expected<\/td>\n<\/tr>\n<tr>\n<td>Testing emphasis<\/td>\n<td>EMC, essential performance, usability<\/td>\n<td>Additional performance validation at depth<\/td>\n<\/tr>\n<tr>\n<td>Labeling nuance<\/td>\n<td>Professional use; environment limits<\/td>\n<td>Clear warnings for sensitive anatomy<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Caution:<\/strong> If a radial device\u2019s <strong>software claims<\/strong> or <strong>marketing<\/strong> infer deeper biological effects or peri-organ targets, the class can escalate. The <strong>la clase final reside en el prop\u00f3sito previsto<\/strong>.<\/p>\n<hr \/>\n<h2>Conclusi\u00f3n<\/h2>\n<p>el cumplimiento de la MDR de la UE es obligatorio; <strong>la clase IIb o III no es obligatoria autom\u00e1ticamente<\/strong> para todos los dispositivos de ondas de choque. La mayor\u00eda de los sistemas ESWT son <strong>Clase IIa o IIb<\/strong> dependiendo del uso previsto y el perfil de energ\u00eda. Los compradores deben exigir certificados de NB, DoC, UDI\/etiquetado, CER y archivos de riesgos que <strong>coincidan con el modelo y las afirmaciones exactas<\/strong>\u2014y confirmar que las indicaciones radiales o enfocadas se alinean con el alcance certificado.<\/p>\n<hr \/>\n<h2>Notas al pie<\/h2>\n<p><span id=\"footnote-1\">1. Texto consolidado no oficial del Anexo VIII de la MDR con las reglas de clasificaci\u00f3n completas. <a href=\"#ref-1\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Resumen de la Comisi\u00f3n Europea del nuevo marco regulatorio MDR\/IVDR. <a href=\"#ref-2\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Resumen del Helpdesk de UDI de la UE de los principios de clasificaci\u00f3n de dispositivos m\u00e9dicos de la MDR. <a href=\"#ref-3\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. Documento de orientaci\u00f3n MDCG 2021-24 sobre la aplicaci\u00f3n de las reglas de clasificaci\u00f3n del Anexo VIII de la MDR. <a href=\"#ref-4\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Art\u00edculo chino que explica las clases de riesgo de la MDR y las reglas de clasificaci\u00f3n para los fabricantes. <a href=\"#ref-5\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. Gu\u00eda pr\u00e1ctica que describe las clases I, IIa, IIb y III de la MDR de la UE y las rutas de conformidad. <a href=\"#ref-6\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u00cdndice de documentos de orientaci\u00f3n respaldados por MDCG que apoyan la implementaci\u00f3n de la MDR. <a href=\"#ref-7\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. Art\u00edculo que reproduce el Art\u00edculo 13 de la MDR sobre las obligaciones generales de los importadores. <a href=\"#ref-8\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. Resumen de consultor\u00eda sobre las obligaciones del importador y preguntas frecuentes en virtud del MDR\/IVDR de la UE. <a href=\"#ref-9\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Notas explicativas sobre las definiciones de clasificaci\u00f3n del MDR, incluidos los dispositivos terap\u00e9uticos activos. <a href=\"#ref-10\">\u21a9\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>As the manufacturer, I am asked this in nearly every EU tender: \u201cIs Class IIb or III mandatory for shockwave systems?\u201d The real answer depends on intended purpose, energy delivery, and MDR Annex VIII rules 1\u2014not on a single, blanket class. MDR Class IIb or III is not automatically mandatory for all shockwave therapy devices. [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8387,"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-8386","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory? - 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\/es\/al-comprar-una-maquina-de-ondas-de-choque-es-obligatorio-el-cumplimiento-del-reglamento-de-dispositivos-medicos-de-la-ue-mdr-clase-iib-o-iii\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?\" \/>\n<meta property=\"og:description\" content=\"As the manufacturer, I am asked this in nearly every EU tender: \u201cIs Class IIb or III mandatory for shockwave systems?\u201d The real answer depends on intended purpose, energy delivery, and MDR Annex VIII rules 1\u2014not on a single, blanket class. MDR Class IIb or III is not automatically mandatory for all shockwave therapy devices. [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kmslaser.com\/es\/al-comprar-una-maquina-de-ondas-de-choque-es-obligatorio-el-cumplimiento-del-reglamento-de-dispositivos-medicos-de-la-ue-mdr-clase-iib-o-iii\/\" \/>\n<meta property=\"og:site_name\" content=\"KMSLaser\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-19T23:35:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Sophia Wu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sophia Wu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/\"},\"author\":{\"name\":\"Sophia Wu\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/person\\\/c37fe1d989e6bd9dbe4f1f7b6cfa9588\"},\"headline\":\"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?\",\"datePublished\":\"2025-11-19T23:35:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/\"},\"wordCount\":1328,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/1a-premium-digital-illustration-showing-a-modern-sh.jpg\",\"articleSection\":[\"Shockwave Therapy Machine\"],\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/\",\"name\":\"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory? - KMSLaser\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/1a-premium-digital-illustration-showing-a-modern-sh.jpg\",\"datePublished\":\"2025-11-19T23:35:50+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#primaryimage\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/1a-premium-digital-illustration-showing-a-modern-sh.jpg\",\"contentUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/1a-premium-digital-illustration-showing-a-modern-sh.jpg\",\"width\":600,\"height\":400},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/kmslaser.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#website\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/\",\"name\":\"KMSLaser\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/kmslaser.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\",\"name\":\"KMSLaser\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/logo.png\",\"contentUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/logo.png\",\"width\":180,\"height\":71,\"caption\":\"KMSLaser\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/person\\\/c37fe1d989e6bd9dbe4f1f7b6cfa9588\",\"name\":\"Sophia Wu\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"caption\":\"Sophia Wu\"},\"url\":\"https:\\\/\\\/kmslaser.com\\\/es\\\/author\\\/sophia\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Al comprar una m\u00e1quina de terapia de ondas de choque, \u00bfes obligatorio el cumplimiento con la Clase IIb o III del Reglamento de Dispositivos M\u00e9dicos de la UE (MDR)? - KMSLaser","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:\/\/kmslaser.com\/es\/al-comprar-una-maquina-de-ondas-de-choque-es-obligatorio-el-cumplimiento-del-reglamento-de-dispositivos-medicos-de-la-ue-mdr-clase-iib-o-iii\/","og_locale":"es_MX","og_type":"article","og_title":"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?","og_description":"As the manufacturer, I am asked this in nearly every EU tender: \u201cIs Class IIb or III mandatory for shockwave systems?\u201d The real answer depends on intended purpose, energy delivery, and MDR Annex VIII rules 1\u2014not on a single, blanket class. MDR Class IIb or III is not automatically mandatory for all shockwave therapy devices. [&hellip;]","og_url":"https:\/\/kmslaser.com\/es\/al-comprar-una-maquina-de-ondas-de-choque-es-obligatorio-el-cumplimiento-del-reglamento-de-dispositivos-medicos-de-la-ue-mdr-clase-iib-o-iii\/","og_site_name":"KMSLaser","article_published_time":"2025-11-19T23:35:50+00:00","og_image":[{"width":600,"height":400,"url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg","type":"image\/jpeg"}],"author":"Sophia Wu","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Sophia Wu","Tiempo de lectura":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#article","isPartOf":{"@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/"},"author":{"name":"Sophia Wu","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588"},"headline":"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?","datePublished":"2025-11-19T23:35:50+00:00","mainEntityOfPage":{"@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/"},"wordCount":1328,"commentCount":0,"publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"image":{"@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg","articleSection":["Shockwave Therapy Machine"],"inLanguage":"es","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/","url":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/","name":"Al comprar una m\u00e1quina de terapia de ondas de choque, \u00bfes obligatorio el cumplimiento con la Clase IIb o III del Reglamento de Dispositivos M\u00e9dicos de la UE (MDR)? - KMSLaser","isPartOf":{"@id":"https:\/\/kmslaser.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#primaryimage"},"image":{"@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg","datePublished":"2025-11-19T23:35:50+00:00","breadcrumb":{"@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#primaryimage","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-premium-digital-illustration-showing-a-modern-sh.jpg","width":600,"height":400},{"@type":"BreadcrumbList","@id":"https:\/\/kmslaser.com\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/kmslaser.com\/"},{"@type":"ListItem","position":2,"name":"When purchasing a Shockwave Therapy Machine, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?"}]},{"@type":"WebSite","@id":"https:\/\/kmslaser.com\/#website","url":"https:\/\/kmslaser.com\/","name":"KMSLaser","description":"","publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/kmslaser.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/kmslaser.com\/#organization","name":"KMSLaser","url":"https:\/\/kmslaser.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/#\/schema\/logo\/image\/","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2020\/02\/logo.png","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2020\/02\/logo.png","width":180,"height":71,"caption":"KMSLaser"},"image":{"@id":"https:\/\/kmslaser.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588","name":"Sophia Wu","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","caption":"Sophia Wu"},"url":"https:\/\/kmslaser.com\/es\/author\/sophia\/"}]}},"_links":{"self":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/8386","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/comments?post=8386"}],"version-history":[{"count":0,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/8386\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media\/8387"}],"wp:attachment":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media?parent=8386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/categories?post=8386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/tags?post=8386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}