CSDmed https://www.csdmed.mc pt Copyright 2026, CSDmed https://www.csdmed.mc/images/logo.svg CSDmed https://www.csdmed.mc Custom RSS Generator by Colibri <![CDATA[MDCG 2021-24 Orientações sobre a classificação dos dispositivos médicos - outubro de 2021]]>
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:2012 ]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-24-guidance-on-classification-of-medical-devices-56 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-24-guidance-on-classification-of-medical-devices-56 Fri, 07 Jan 2022 00:00:00 +0100 <![CDATA[MDCG 2021-28 Alteração substancial da investigação clínica ao abrigo do Regulamento relativo aos dispositivos médicos - dezembro de 2021]]>
A 9 de dezembro de 2021, o Grupo de Coordenação dos Dispositivos Médicos (MDCG) publicou um novo documento de orientação. Este novo documento fornece orientações no que diz respeito a modificações substanciais da investigação clínica ao abrigo do Regulamento relativo aos dispositivos médicos (MDCG 2021-28). ]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-28-substantial-modification-of-clinical-investigation-under-medical-device-regulation-57 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-28-substantial-modification-of-clinical-investigation-under-medical-device-regulation-57 Thu, 13 Jan 2022 00:00:00 +0100 <![CDATA[MDCG 2022-16 Orientações sobre representantes autorizados ao abrigo do RDM e do RIV]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2022-16-guidance-on-authorised-representatives-under-mdr-ivdr-58 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2022-16-guidance-on-authorised-representatives-under-mdr-ivdr-58 Tue, 01 Nov 2022 00:00:00 +0100 <![CDATA[Prorrogação do período de transição do Regulamento Dispositivos Médicos (MDR 2017/745)]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/extension-of-transitional-period-of-medical-device-regulation-mdr-2017-745-59 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/extension-of-transitional-period-of-medical-device-regulation-mdr-2017-745-59 Mon, 12 Dec 2022 00:00:00 +0100 <![CDATA[MDCG 2023-1 - Orientações sobre a isenção das instituições de saúde ao abrigo do artigo 5.º, n.º 5, do Regulamento (UE) 2017/745 e do Regulamento (UE) 2017/746]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-1-guidance-on-the-health-institution-exemption-under-article-5-5-of-regulation-eu-2017-745-and-regulation-eu-2017-746-60 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-1-guidance-on-the-health-institution-exemption-under-article-5-5-of-regulation-eu-2017-745-and-regulation-eu-2017-746-60 Tue, 10 Jan 2023 00:00:00 +0100 <![CDATA[Come, find and meet us during the 11th edition of "la rentrée du DM" at the Kursaal of Besançon.]]>
]]> https://www.csdmed.mc/pt/actualites/news/come-find-and-meet-us-during-the-11th-edition-of-the-la-rentree-du-dm-at-the-kursaal-of-besancon-61 https://www.csdmed.mc/pt/actualites/news/come-find-and-meet-us-during-the-11th-edition-of-the-la-rentree-du-dm-at-the-kursaal-of-besancon-61 Tue, 20 Jun 2023 00:00:00 +0200 <![CDATA[Notícias emocionantes! A CSDmed é agora membro do Clube de Aderentes da AFNOR]]>
]]> https://www.csdmed.mc/pt/actualites/news/exciting-news-csdmed-is-now-a-member-of-the-afnor-adherents-club-62 https://www.csdmed.mc/pt/actualites/news/exciting-news-csdmed-is-now-a-member-of-the-afnor-adherents-club-62 Tue, 11 Jul 2023 00:00:00 +0200 <![CDATA[MDR 2017/745 consolidado com os regulamentos 2023-607 e 2020-561]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdr-2017-745-consolidated-with-regulations-2023-607-and-2020-561-63 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdr-2017-745-consolidated-with-regulations-2023-607-and-2020-561-63 Mon, 27 Mar 2023 00:00:00 +0200 <![CDATA[Os riscos ocultos do aprovisionamento de equipamento médico na China]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/the-hidden-risks-of-sourcing-medical-equipment-from-china-64 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/the-hidden-risks-of-sourcing-medical-equipment-from-china-64 Tue, 25 Jul 2023 00:00:00 +0200 <![CDATA[Compreender a importância do Plano de Gestão do Risco (PGR) nos Dispositivos Médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/understanding-the-imperative-of-risk-management-plan-rmp-in-medical-devices-65 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/understanding-the-imperative-of-risk-management-plan-rmp-in-medical-devices-65 Mon, 04 Sep 2023 00:00:00 +0200 <![CDATA[Nova edição do Guia da FDA: Utilização da Norma Internacional ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/new-issue-of-the-fda-guidance-use-of-international-standard-iso-10993-1-biological-evaluation-of-medical-devices-part-1-evaluation-and-testing-within-a-risk-management-process-66 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/new-issue-of-the-fda-guidance-use-of-international-standard-iso-10993-1-biological-evaluation-of-medical-devices-part-1-evaluation-and-testing-within-a-risk-management-process-66 Fri, 15 Sep 2023 00:00:00 +0200 <![CDATA[O que é um dispositivo médico?]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/what-is-a-medical-device-67 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/what-is-a-medical-device-67 Thu, 21 Sep 2023 00:00:00 +0200 <![CDATA[Novo manual sobre limites e classificação de dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/new-manual-on-borderline-and-classification-for-medical-devices-68 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/new-manual-on-borderline-and-classification-for-medical-devices-68 Mon, 02 Oct 2023 00:00:00 +0200 <![CDATA[Classificação dos dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/medical-devices-classification-69 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/medical-devices-classification-69 Fri, 13 Oct 2023 00:00:00 +0200 <![CDATA[Novo guia MDCG 2023-4: Software para Dispositivos Médicos (MDSW) - Combinações de hardware]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-4-software-hardware-combinations-70 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-4-software-hardware-combinations-70 Thu, 19 Oct 2023 00:00:00 +0200 <![CDATA[Novo documento de alteração do RDM da UE 2017/745: o documento UE 2023/2197]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/new-amending-document-2023-2197-71 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/new-amending-document-2023-2197-71 Fri, 20 Oct 2023 00:00:00 +0200 <![CDATA[Orientações sobre dispositivos médicos assentes na aprendizagem automática (MLMD)]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/guidance-machine-learning-enabled-medical-devices-72 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/guidance-machine-learning-enabled-medical-devices-72 Fri, 27 Oct 2023 00:00:00 +0200 <![CDATA[O calendário de acordo com o Regulamento de alteração 2023/607]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/calendar-amending-regulation-2023-607-73 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/calendar-amending-regulation-2023-607-73 Wed, 01 Nov 2023 00:00:00 +0100 <![CDATA[Regulamento de Execução (UE) 2022/2346 e (UE) 2023/1194 das disposições do anexo XVI do RDM 2017/745 - gestão dos riscos e disposições transitórias]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/regulation-2022-2346-and-2023-11194-74 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/regulation-2022-2346-and-2023-11194-74 Fri, 03 Nov 2023 00:00:00 +0100 <![CDATA[Interface entre os regulamentos relativos aos ensaios clínicos de medicamentos, dispositivos médicos e diagnósticos in vitro]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/clinical-trial-combined-studies-project-75 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/clinical-trial-combined-studies-project-75 Tue, 14 Nov 2023 00:00:00 +0100 <![CDATA[Nova edição do documento de posição do MDCG: MDCG 2022-11 revisão 1 - Aviso aos fabricantes e NB]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2022-11-revision1-76 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2022-11-revision1-76 Wed, 29 Nov 2023 00:00:00 +0100 <![CDATA[(CE) 2023/2482 que altera o Regulamento (CE) n.º 1907/2006]]>
]]> https://www.csdmed.mc/pt/actualites/news/regulation-2023-2482-phtalates-77 https://www.csdmed.mc/pt/actualites/news/regulation-2023-2482-phtalates-77 Tue, 05 Dec 2023 00:00:00 +0100 <![CDATA[Nova versão: MDCG 2021-6 Rev. 1 - Perguntas e respostas sobre investigação clínica]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-6-rev1-78 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-6-rev1-78 Tue, 12 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2023-5 e MDCG 2023-6: dois pelo preço de um - Produtos sem finalidade médica prevista nos termos do Anexo XVI]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-5-and-mdcg-2023-6-79 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-5-and-mdcg-2023-6-79 Fri, 15 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2021-27 Rev.1 - Funções e responsabilidades dos importadores e distribuidores de dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-27-rev1-80 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2021-27-rev1-80 Tue, 19 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2019-07 Rev.1 (PRRC)]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2019-07-rev1-prrc-81 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2019-07-rev1-prrc-81 Tue, 19 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2023-7 Orientações sobre as isenções à obrigação de efetuar investigações clínicas nos termos dos n.ºs 4 a 6 do artigo 61.º do RDM e sobre os níveis suficientes de acesso aos dados necessários para justificar as alegações de equivalência]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-7-exemptions-clinical-investigations-82 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2023-7-exemptions-clinical-investigations-82 Fri, 22 Dec 2023 00:00:00 +0100 <![CDATA[ISO 42001:2023 Inteligência artificial - Sistema de gestão]]>
]]> https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/iso-42001-2023-artificial-intelligence-83 https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/iso-42001-2023-artificial-intelligence-83 Fri, 22 Dec 2023 00:00:00 +0100 <![CDATA[Base NANDO - situação em 1 de janeiro de 2024]]>
]]> https://www.csdmed.mc/pt/actualites/news/nando-base-january-2024-84 https://www.csdmed.mc/pt/actualites/news/nando-base-january-2024-84 Thu, 11 Jan 2024 00:00:00 +0100 <![CDATA[requisitos linguísticos para os fabricantes]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/language-requirements-manufacturers-mdr-ivdr-85 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/language-requirements-manufacturers-mdr-ivdr-85 Thu, 18 Jan 2024 00:00:00 +0100 <![CDATA[MDCG 2024-2 sobre a atualização dos códigos EMDN]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2024-2-update-emdn-86 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2024-2-update-emdn-86 Tue, 06 Feb 2024 00:00:00 +0100 <![CDATA[Ato da AI: A França aceita finalmente a proposta, sob condições]]>
]]> https://www.csdmed.mc/pt/actualites/news/ia-act-france-finally-accepts-the-proposal-under-conditions-87 https://www.csdmed.mc/pt/actualites/news/ia-act-france-finally-accepts-the-proposal-under-conditions-87 Tue, 06 Feb 2024 00:00:00 +0100 <![CDATA[Guia da UE: Visão geral do EUDAMED e como registar a sua empresa]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/eudamed-overview-88 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/eudamed-overview-88 Thu, 15 Feb 2024 00:00:00 +0100 <![CDATA[Comunicado conjunto da ISO e do IAF sobre as alterações climáticas]]>
]]> https://www.csdmed.mc/pt/actualites/news/iso-iaf-communique-climat-change-89 https://www.csdmed.mc/pt/actualites/news/iso-iaf-communique-climat-change-89 Thu, 22 Feb 2024 00:00:00 +0100 <![CDATA[Estrutura HLS na ISO-IEC 42001]]>
]]> https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/management-system-hls-structure-90 https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/management-system-hls-structure-90 Sat, 02 Mar 2024 00:00:00 +0100 <![CDATA[Diretiva SRI 2]]>
]]> https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/nis2-directive-91 https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/nis2-directive-91 Fri, 08 Mar 2024 00:00:00 +0100 <![CDATA[Orientação MDCG 2024-3 - conteúdo do Plano de Investigação Clínica (PIC)]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/guide-mdcg-2024-3-92 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/guide-mdcg-2024-3-92 Wed, 13 Mar 2024 00:00:00 +0100 <![CDATA[Normas harmonizadas actualizadas em março de 2024]]>
]]> https://www.csdmed.mc/pt/actualites/news/harmonized-standards-update-march-2024-93 https://www.csdmed.mc/pt/actualites/news/harmonized-standards-update-march-2024-93 Sun, 17 Mar 2024 00:00:00 +0100 <![CDATA[Autoridades competentes e registo de dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/news/competent-authorities-94 https://www.csdmed.mc/pt/actualites/news/competent-authorities-94 Wed, 27 Mar 2024 00:00:00 +0100 <![CDATA[Até que ponto podem os dados apoiar a transformação da saúde através da IA?]]>
]]> https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/data-support-health-transformation-through-ai-95 https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/data-support-health-transformation-through-ai-95 Fri, 05 Apr 2024 00:00:00 +0200 <![CDATA[Declaração de aplicabilidade de acordo com a secção 6.1.3 da norma ISO/IEC 42001:2023]]>
]]> https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/statement-of-applicability-iso-42001-96 https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/statement-of-applicability-iso-42001-96 Sun, 07 Apr 2024 00:00:00 +0200 <![CDATA[Adoção bem sucedida e atempada da inteligência artificial na ciência na UE]]>
]]> https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/ai-uptake-medical-eu-97 https://www.csdmed.mc/pt/actualites/md-ai-and-cybersecurity/ai-uptake-medical-eu-97 Mon, 15 Apr 2024 00:00:00 +0200 <![CDATA[MDCG 2024-5 - Orientações sobre o conteúdo da brochura do investigador para investigações clínicas de dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2024-5-98 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2024-5-98 Wed, 17 Apr 2024 00:00:00 +0200 <![CDATA[Vigilância pós-mercado]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/post-market-surveillance-pms-99 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/post-market-surveillance-pms-99 Fri, 26 Apr 2024 00:00:00 +0200 <![CDATA[Esterilização por CO₂ supercrítico: Uma alternativa ecológica e sustentável para dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/supercritical-co2-sterilization-100 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/supercritical-co2-sterilization-100 Mon, 06 May 2024 00:00:00 +0200 <![CDATA[Perspetiva do sector dos dispositivos médicos em 2023: Principais dados e tendências]]>
]]> https://www.csdmed.mc/pt/actualites/news/insight-into-the-medical-devices-sector-in-2023-key-data-and-trends-101 https://www.csdmed.mc/pt/actualites/news/insight-into-the-medical-devices-sector-in-2023-key-data-and-trends-101 Thu, 16 May 2024 00:00:00 +0200 <![CDATA[Validação de métodos para ensaios de verificação em dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/method-validation-102 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/method-validation-102 Tue, 11 Jun 2024 00:00:00 +0200 <![CDATA[Atualização exaustiva das diretrizes para a avaliação benefício-risco dos ftalatos CMR/ED nos dispositivos médicos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-scheer-o-064-103 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-scheer-o-064-103 Tue, 18 Jun 2024 00:00:00 +0200 <![CDATA[MDCG 2024-10 Avaliação clínica de dispositivos médicos órfãos]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2024-10-clinical-evaluation-of-orphan-medical-devices-104 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/mdcg-2024-10-clinical-evaluation-of-orphan-medical-devices-104 Tue, 25 Jun 2024 00:00:00 +0200 <![CDATA[Estrutura harmonizada para submissões regulamentares de IVD]]>
]]> https://www.csdmed.mc/pt/actualites/medical-devices-regulation/imdrf-ivd-toc-v4-105 https://www.csdmed.mc/pt/actualites/medical-devices-regulation/imdrf-ivd-toc-v4-105 Wed, 26 Jun 2024 00:00:00 +0200