{"id":1575,"date":"2023-03-20T20:33:38","date_gmt":"2023-03-20T20:33:38","guid":{"rendered":"https:\/\/medev.es\/?page_id=1575"},"modified":"2023-03-22T19:29:47","modified_gmt":"2023-03-22T19:29:47","slug":"noticias-medev-consulting","status":"publish","type":"page","link":"https:\/\/medev.es\/?page_id=1575","title":{"rendered":"Noticias MeDev Consulting"},"content":{"rendered":"\t\t
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\n\t\t\t\n\t\t\t\tMDD \u00abLegacy\u00bb Nueva declaraci\u00f3n de conformidad del fabricante en relaci\u00f3n con el Reglamento (UE) 2023\/607\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-07-24\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u00a0 \u00a0 \u00a0 MedTech Europe* pone a disposici\u00f3n una plantilla de Declaraci\u00f3n del fabricante para facilitar la declaraci\u00f3n de los fabricantes con respecto al Reglamento<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tLa MHRA anuncia una pr\u00f3rroga adicional del periodo de espera del marcado UKCA\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
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La MHRA anuncia una pr\u00f3rroga adicional del periodo de espera del marcado UKCA<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tLa comision europea publica el modelo de confirmation letter necesario para poder ampliar los periodos del MDD\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-05-31\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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La Comisi\u00f3n Europea publica el modelo de \u00abConfirmation Letter\u00bb necesaria para poder aplicar los periodos transitorios extendidos del reglamento 2023\/607<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tNueva actualizacion MDGC 2020-3 cambios significativos equipos bajo MDD\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-05-15\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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Se ha publicado una \ud835\uddee\ud835\uddf0\ud835\ude01\ud835\ude02\ud835\uddee\ud835\uddf9\ud835\uddf6\ud835\ude07\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf1\ud835\uddf2 \ud835\uddf9\ud835\uddee \ud835\uddda\ud835\ude02\ud835\uddf6\u0301\ud835\uddee \ud835\udde0\ud835\uddd7\ud835\uddd6\ud835\uddda \ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfec-\ud835\udfef sobre \ud835\uddf0\ud835\uddee\ud835\uddfa\ud835\uddef\ud835\uddf6\ud835\uddfc\ud835\ude00 \ud835\ude00\ud835\uddf6\ud835\uddf4\ud835\uddfb\ud835\uddf6\ud835\uddf3\ud835\uddf6\ud835\uddf0\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\ude03\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\uddfb \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf0\ud835\uddfc\ud835\uddfb \ud835\uddf9\ud835\uddee \ud835\uddf1\ud835\uddf6\ud835\ude00\ud835\uddfd\ud835\uddfc\ud835\ude00\ud835\uddf6\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\ude01\ud835\uddff\ud835\uddee\ud835\uddfb\ud835\ude00\ud835\uddf6\ud835\ude01\ud835\uddfc\ud835\uddff\ud835\uddf6\ud835\uddee \ud835\uddf1\ud835\uddf2\ud835\uddf9 \ud835\uddee\ud835\uddff\ud835\ude01\ud835\uddf6\u0301\ud835\uddf0\ud835\ude02\ud835\uddf9\ud835\uddfc \ud835\udfed\ud835\udfee\ud835\udfec \ud835\uddf1\ud835\uddf2\ud835\uddf9 \ud835\udde0\ud835\uddd7\ud835\udde5 para productos sanitarios certificados por MDD o AIMDD.<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tLa\u00a0AEMPS\u00a0actualiza la \ud835\uddf6\ud835\uddfb\ud835\ude00\ud835\ude01\ud835\uddff\ud835\ude02\ud835\uddf0\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\udde3\ud835\udde6\ud835\udfed\/\ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfee \ud835\uddf6\ud835\uddfb\ud835\uddf0\ud835\uddf9\ud835\ude02yendo los \ud835\uddff\ud835\uddf2\ud835\uddfe\ud835\ude02\ud835\uddf6\ud835\ude00\ud835\uddf6\ud835\ude01\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\ude00\ud835\ude01\ud835\uddee\ud835\uddef\ud835\uddf9\ud835\uddf2\ud835\uddf0\ud835\uddf6\ud835\uddf1\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\uddfb \ud835\uddf2\ud835\uddf9 \ud835\udde5\ud835\uddf2\ud835\uddee\ud835\uddf9 \ud835\uddd7\ud835\uddf2\ud835\uddf0\ud835\uddff\ud835\uddf2\ud835\ude01\ud835\uddfc \ud835\udfed\ud835\udff5\ud835\udfee\/\ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfef, de 21 de marzo, por el que se regulan los productos sanitarios.\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
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\ud83d\udce2 La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios informa de la actualizaci\u00f3n de la \ud835\uddee\ud835\uddfb\ud835\ude01\ud835\uddf2\ud835\uddff\ud835\uddf6\ud835\uddfc\ud835\uddff \ud835\uddf6\ud835\uddfb\ud835\ude00\ud835\ude01\ud835\uddff\ud835\ude02\ud835\uddf0\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\udde3\ud835\udde6\ud835\udfed\/\ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfee \ud835\uddfd\ud835\uddee\ud835\uddff\ud835\uddee \ud835\uddf6\ud835\uddfb\ud835\uddf0\ud835\uddf9\ud835\ude02\ud835\uddf6\ud835\uddff \ud835\uddff\ud835\uddf2\ud835\uddfe\ud835\ude02\ud835\uddf6\ud835\ude00\ud835\uddf6\ud835\ude01\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\ude00\ud835\ude01\ud835\uddee\ud835\uddef\ud835\uddf9\ud835\uddf2\ud835\uddf0\ud835\uddf6\ud835\uddf1\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\uddfb \ud835\uddf2\ud835\uddf9 \ud835\udde5\ud835\uddf2\ud835\uddee\ud835\uddf9 \ud835\uddd7\ud835\uddf2\ud835\uddf0\ud835\uddff\ud835\uddf2\ud835\ude01\ud835\uddfc \ud835\udfed\ud835\udff5\ud835\udfee\/\ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfef, de 21 de marzo, por el que se regulan los productos sanitarios.<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tQuestions and Answers: Extension of the transitional periods MDD\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-03-27\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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Preguntas y respuestas: La Comisi\u00f3n propone una ampliaci\u00f3n de los periodos transitorios para la aplicaci\u00f3n del Reglamento sobre productos sanitarios<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tSe ha publicado hoy en el BOE el \ud835\uddfb\ud835\ude02\ud835\uddf2\ud835\ude03\ud835\uddfc \ud835\udde5\ud835\uddf2\ud835\uddee\ud835\uddf9 \ud835\uddd7\ud835\uddf2\ud835\uddf0\ud835\uddff\ud835\uddf2\ud835\ude01\ud835\uddfc \ud835\uddf1\ud835\uddf2 \ud835\udde3\ud835\uddff\ud835\uddfc\ud835\uddf1\ud835\ude02\ud835\uddf0\ud835\ude01\ud835\uddfc\ud835\ude00 \ud835\udde6\ud835\uddee\ud835\uddfb\ud835\uddf6\ud835\ude01\ud835\uddee\ud835\uddff\ud835\uddf6\ud835\uddfc\ud835\ude00 21 de Marzo 2023\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-03-22\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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Se trata del RD 192\/2023 de 21 de marzo de 2023.
\nEl Real Decreto entra en vigor ma\u00f1ana (23 de marzo).<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tNuevo RD de productos sanitarios\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-03-21\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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El Consejo de Ministros aprueba el Real Decreto que regula los productos sanitarios
\nEsta norma sustituye a la que estaba en vigor desde 2019 y su funci\u00f3n es adaptar la normativa nacional sobre productos sanitarios en funci\u00f3n de lo dictado por el Reglamento de la Uni\u00f3n Europea, que se est\u00e1 aplicando desde 2021.<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tAmpliaci\u00f3n plazo validez Directiva MDD\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2023-03-20\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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Ha entrado en vigor el REGLAMENTO (UE) 2023\/607 prorrogando la validez de los certificados expedidos de conformidad con las Directivas 90\/385\/CEE y 93\/42\/CEE.<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tMDCG: nueva MDCG 2022-18 sobre productos legacy cuyo certificado MDD antes de la expedici\u00f3n de un certificado MDR\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2022-12-10\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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MDCG: nueva MDCG 2022-18 Documento de posici\u00f3n sobre la aplicaci\u00f3n del art\u00edculo 97 MDR a los productos legacy cuyo certificado MDD o AIMDD expira antes de la expedici\u00f3n de un certificado MDR<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tMDCG 2022-17 Auditorias hibridas\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t2022-12-06\t\t<\/span>\n\t\t\t\t\n\t\t\tNo hay comentarios\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t
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MDCG 2022-17 de Auditorias hibridas. Directriz sobre \u201c hybrid audits \u201d presenciales y a distancia<\/p>\n\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\tRead More \u00bb\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<\/div>\n\n\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-1575","page","type-page","status-publish","hentry"],"yoast_head":"\nNoticias MeDev Consulting - MeDev<\/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:\/\/medev.es\/?page_id=1575\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Noticias MeDev Consulting - 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