O MDCG 2025-1 introduz um formulário de procedimento ad-hoc para facilitar a atualização da Nomenclatura Europeia de Dispositivos Médicos (EMDN). Este documento é crucial para fabricantes, autoridades competentes nacionais (NCA) e organismos notificados (NB) que necessitem de registar dispositivos no módulo UDI-DI da EUDAMED. A nova abordagem permite a submissão de propostas para novos códigos quando os já existentes não são suficientes, promovendo o registo de tecnologias inovadoras e a conformidade regulatória. Esta iniciativa do Medical Device Coordination Group (MDCG) contribui para a padronização e clareza no setor de dispositivos médicos na União Europeia.

O MDCG 2021-12 Rev.1 FAQ fornece uma explicação detalhada sobre a Nomenclatura Europeia de Dispositivos Médicos (EMDN), sendo um recurso essencial para garantir a conformidade dos dispositivos médicos e IVD no contexto das regulamentações MDR e IVDR da União Europeia. Com a revisão de janeiro de 2025, este documento orienta os fabricantes sobre como atribuir corretamente os códigos EMDN aos seus dispositivos no EUDAMED. Além disso, esclarece aspectos sobre a estrutura hierárquica da nomenclatura, a utilização dos códigos alfanuméricos e o processo de atualização anual da nomenclatura.

A MDCG 2024-2 Rev.1 inaugura uma nova era para a Nomenclatura Europeia de Dispositivos Médicos (RME), estabelecendo procedimentos dinâmicos que garantem inovação, segurança e eficiência no setor de dispositivos médicos. Esta revisão, alinhada aos regulamentos MDR e IVDR, introduz atualizações anuais e solicitações ad-hoc para atender às rápidas mudanças tecnológicas e às crescentes exigências do mercado. Com um foco na colaboração entre stakeholders, a atualização reforça a confiança entre fabricantes, profissionais de saúde e pacientes, garantindo que a classificação dos dispositivos seja precisa, relevante e segura.

A cibersegurança nos hospitais tornou-se uma prioridade essencial com a crescente digitalização dos serviços de saúde, incluindo registos eletrónicos de saúde, telemedicina e diagnósticos baseados em IA. A União Europeia lançou o Plano de Ação Europeu para a Cibersegurança de Hospitais e Prestadores de Cuidados de Saúde, com foco na prevenção de ataques cibernéticos, detecção de ameaças, e a melhoria da resposta e recuperação para minimizar o impacto de incidentes como o ransomware. Este plano inclui medidas como a criação de um Centro Europeu de Apoio à Cibersegurança, avaliações anuais de maturidade cibernética e formação para profissionais de saúde, garantindo um futuro seguro e inovador para os cuidados de saúde em toda a UE.

A Inteligência Artificial (IA) está a transformar o setor da saúde, apresentando-se como uma ferramenta essencial para alcançar equidade global, melhorar a eficiência operacional e impulsionar a inovação em saúde. Segundo o relatório do Fórum Económico Mundial, The Future of AI-Enabled Health: Leading the Way, a adoção de soluções de IA exige enfrentar desafios relacionados com a governança fragmentada, a falta de alinhamento estratégico e a necessidade de parcerias público-privadas eficazes. Este documento destaca ainda seis transições fundamentais para assegurar que a IA alcance o seu pleno potencial na transformação digital da saúde, promovendo um futuro mais inteligente e saudável.

O Regulamento de Execução (UE) 2025/117 introduz regras detalhadas para consultas científicas conjuntas no âmbito do Regulamento HTA, promovendo a colaboração entre quem desenvolvem dispositivos médicos e IVDs, especialistas clínicos, pacientes e partes interessadas. Este novo quadro regulamentar, em vigor desde janeiro de 2025, reforça a inovação tecnológica ao proporcionar orientações claras sobre os requisitos de evidência clínica, facilitando o processo de avaliação clínica conjunta. A colaboração com a Agência Europeia de Medicamentos (EMA) é outro destaque, garantindo consultas sincronizadas com revisões de painéis de peritos. Este regulamento representa um passo importante para melhorar a conformidade regulamentar e apoiar a introdução de tecnologias de saúde inovadoras no mercado da União Europeia.

The European Commission has released the updated list of National Contact Points for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This essential resource supports compliance for manufacturers, distributors, and stakeholders in the medical device industry. The document includes key updates, such as revised details for Estonia's State Agency of Medicines. Stay informed about the MDR/IVDR landscape, ensure regulatory compliance, and access direct communication with EU competent authorities. Download the latest MDR and IVDR contact points document to stay ahead in the medical device and diagnostic regulation industry.

O recente estudo sobre o Regulamento HTA da UE para Dispositivos Médicos Digitais (DMDs), incluindo tecnologias baseadas em Inteligência Artificial, destaca a necessidade de uma avaliação adaptativa e da harmonização europeia para garantir o acesso ao mercado e o reembolso eficaz. O estudo explora os desafios e oportunidades no setor, como a falta de foco na IA e as dificuldades de adaptação aos ciclos de vida curtos dos DMDs, mas também aponta para melhorias através da incorporação de evidências do mundo real. Destaca-se a importância da transparência regulamentar e das vias de acesso acelerado, com exemplos inovadores como o DiGA na Alemanha e o PECAN em França. A harmonização das metodologias de avaliação na União Europeia é essencial para fomentar a inovação e a competitividade no setor dos dispositivos médicos digitais.

The revised Preliminary Assessment Review (PAR) templates under the MDR (Regulation (EU) 2017/745) bring critical updates for Notified Bodies and the medical device industry. Published by the Medical Device Coordination Group (MDCG) in January 2025, the revisions focus on simplifying regulatory processes, including the removal of redundant sections and enhancing annexes for detailed guidance. These updates are essential for companies aiming for regulatory compliance, CE marking, and alignment with European medical device regulations.

The FDA draft guidance for Artificial Intelligence-Enabled Device Software Functions (AI-DSFs) offers comprehensive recommendations to manufacturers on lifecycle management, transparency, and bias mitigation. Emphasizing a Total Product Life Cycle (TPLC) approach, the guidance ensures AI-enabled devices meet regulatory standards, maintain safety, and address the needs of diverse patient demographics, including race, ethnicity, sex, and age. By adopting FDA-recognized consensus standards and implementing strategies to manage AI-related risks, manufacturers can enhance the quality and effectiveness of their devices. Early engagement with the FDA for combination products that integrate AI-DSFs is encouraged, fostering compliance and innovation in medical device development.

The FDA's updated guidance emphasizes the importance of including sex- and gender-specific data in medical device clinical studies, urging manufacturers to address differences in device performance and safety related to these factors. By considering variables like age, race, and ethnicity, the guidance promotes inclusivity and ensures studies reflect real-world patient demographics. Sponsors are encouraged to integrate these practices alongside device-specific recommendations to enhance reliability, regulatory compliance, and healthcare equity. This approach aligns with the FDA's commitment to improving outcomes for diverse populations through comprehensive and inclusive clinical evaluations.

MDCG 2024-8 Revision 1 brings crucial updates for IVDR compliance, including streamlined processes for conformity assessment and updated guidelines for notified bodies. Stay informed about regulatory changes in in vitro diagnostic devices under Regulation (EU) 2017/746. Learn how Smart MDR can support your business with expert guidance on IVDR conformity, ensuring compliance with EU medical device regulations. From quality management systems to technical documentation, we help you navigate the complexities of regulatory frameworks with confidence.

The revised MDCG 2023-3 Rev2 guidance addresses key aspects of vigilance reporting under the EU Medical Device Regulation (MDR) 2017/745. It offers detailed definitions of critical terms, such as serious incidents, field safety corrective actions, and adverse events, while emphasizing the importance of timely reporting by manufacturers, authorized representatives, and other stakeholders. By clarifying roles and responsibilities across the medical device lifecycle, the updated guidance ensures compliance with stringent safety standards. Manufacturers and distributors can enhance device safety, minimize patient risks, and streamline their regulatory processes by adhering to these recommendations.

The FDA's updated guidance on Section 506J of the FD&C Act, introduced by the CARES Act, provides crucial information for manufacturers of medical devices. This guidance outlines mandatory notifications for production interruptions or permanent discontinuations that could disrupt the supply of essential devices during a public health emergency. It clarifies which medical devices fall under these requirements, the appropriate timing and format for notifications, and additional voluntary details to assist the FDA in mitigating shortages. By strengthening safeguards in the medical device supply chain, the FDA aims to ensure consistent availability of critical devices, reinforcing the importance of proactive communication from manufacturers to support public health.

The FDA’s draft guidance on pulse oximeters provides critical recommendations for non-clinical and clinical performance testing, addressing concerns about factors such as skin pigmentation and oxygen saturation levels. The guidance emphasizes the importance of accurate evaluations to ensure reliable results in diverse conditions. Manufacturers are advised to follow FDA-recognized consensus standards and integrate these recommendations into premarket submissions for regulatory compliance. Additionally, the guidance highlights transparent labeling practices, informing users of potential limitations, such as inaccuracy due to poor circulation or pigmentation. This comprehensive approach ensures that both healthcare providers and patients can trust pulse oximeter data for critical health decisions.

The FDA's latest guidance on artificial intelligence (AI) models in regulatory decision-making for drug development introduces a risk-based credibility assessment framework to ensure the reliability of AI outputs. This framework tailors oversight levels, performance criteria, and risk mitigation strategies to the AI model's context of use (COU) and associated risks. Sponsors are encouraged to engage early with the FDA to align their AI applications with regulatory expectations, focusing on safety, effectiveness, and quality. While the guidance excludes AI applications in drug discovery and operational efficiencies not impacting patient safety, it highlights the importance of detailed documentation and planning for credible AI model deployment in regulatory processes.

Smart MDR launches an exclusive campaign for startups and SMEs entering the European medical device market, offering critical regulatory support. Benefit from a 10% discount on CE marking, ensuring your devices comply with EU MDR regulations, and enjoy 6 months of free PRRC services, meeting the Person Responsible for Regulatory Compliance requirement. This campaign simplifies the path to European market access, providing specialized support for medical devices, IVD, and SaMD. With over 20 years of regulatory experience, Smart MDR’s expert team, led by Sandra Balseiro, guides you through the complexities of compliance. This limited-time offer, available until January 31st, is a unique chance to ensure your device's compliance while saving costs. Schedule your meeting today and advance confidently into the European market!

The European Union's second draft of the General-Purpose AI Code of Practice is a pivotal framework for AI providers aiming to achieve compliance with the AI Act, effective August 2, 2025. Building on feedback from over 1,000 stakeholders, this draft outlines best practices for managing the entire AI lifecycle, from development to deployment and monitoring. Key principles such as ethics, transparency, and accountability are emphasized to foster public trust in AI technologies while addressing compliance challenges. Stakeholders are invited to provide input on the draft by January 15, 2025, as the EU works toward finalizing a balanced framework that supports AI innovation and safeguards societal values.

The revised MDCG 2022-3 Rev.1 guidance introduces significant updates to the verification process for Class D in vitro diagnostic devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR). Published in December 2024, this document outlines a more structured approach to batch verification by Notified Bodies, ensuring high-risk diagnostic devices meet stringent safety and performance standards. By improving compliance measures and requiring enhanced documentation, the guidance streamlines market access while maintaining rigorous oversight. These updates aim to facilitate the introduction of safer, high-quality diagnostic tools, enhancing patient safety and strengthening the healthcare ecosystem. Manufacturers are encouraged to align with these new requirements for faster and safer market entry.

The newly released Team-NB Consensus Document on the EU MDR certification process is a crucial resource for manufacturers navigating the Medical Device Regulation (EU) 2017/745. Published on December 18, 2024, this guide outlines the critical steps of the certification journey, including device classification, technical documentation preparation, and conformity assessments. It provides practical strategies for manufacturers transitioning legacy devices or certifying new products, ensuring compliance with MDR requirements. The document also highlights the importance of ongoing audits and surveillance to maintain regulatory standards. By simplifying processes and promoting consistency, the initiative fosters faster time-to-market, enhances regulatory adherence, and strengthens patient safety across the EU medical device industry.