The FDA’s guidance on Predetermined Change Control Plans (PCCP) offers clear recommendations for integrating AI-enabled device software functions into the medical device industry. This framework allows manufacturers to implement pre-approved modifications to their AI-driven software without requiring new marketing submissions, streamlining the regulatory process. By addressing the unique needs of AI algorithms, such as ongoing updates and improvements, the PCCP ensures that these advancements maintain safety, efficacy, and compliance. The FDA emphasizes transparency and monitoring, enabling medical devices to evolve while adhering to rigorous regulatory standards. This innovative approach fosters AI innovation, empowering companies to deploy responsive and adaptive AI-enabled medical technologies that enhance patient care and outcomes.

The MDCG 2024-15 guidance provides crucial instructions on managing clinical investigation reports and plain-language summaries in the absence of EUDAMED, the European database for medical devices. This interim solution ensures compliance with MDR Article 77, emphasizing the importance of transparency and public accountability. Sponsors must submit clinical reports within one year of the investigation's conclusion or three months for early terminations, with public access aligning with device registration or defaulting to one year after submission. To address the gap left by EUDAMED, national procedures and the CIRCABC directory will temporarily facilitate the sharing of these documents. By adapting to these measures, stakeholders can maintain regulatory compliance and foster confidence in the medical device industry, aligning with evolving EU regulations.

The ISO/DIS 20417 standard, titled "Medical Devices — Information to Be Supplied by the Manufacturer," provides key guidelines to ensure that manufacturers deliver clear, consistent, and comprehensive information with their medical devices. Published on November 29, 2024, the draft focuses on essential elements such as instructions for use, safety warnings, and performance details, aiming to standardize the information manufacturers must provide. This initiative is crucial in improving transparency and usability, benefiting both healthcare professionals and end users, while enhancing patient safety. The updated standard also addresses the increasing complexity of digital and software-based devices, ensuring manufacturers meet regulatory compliance and facilitate global market access. Stakeholders in the medical device industry are encouraged to review and provide feedback to help shape the final version of this important standard.

O mais recente 𝗤&𝗔 𝗼𝗻 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟭𝟬𝗮 está aqui, e é uma leitura essencial para todos os profissionais de dispositivos médicos e IVD! Este guia abrangente aborda o novo 𝗼𝗯𝗹𝗶𝗴𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗶𝗻𝗳𝗼𝗿𝗺 em casos de 𝘀𝘂𝗽𝗽𝗹𝘆 𝗶𝗻𝘁𝗲𝗿𝗿𝘂𝗽𝘁𝗶𝗼𝗻 𝗼𝗿 𝗶𝘀𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗮𝘁𝗶𝗼𝗻, garantindo que o acesso dos pacientes a dispositivos que salvam vidas nunca seja comprometido.

O Team-NB publicou um comunicado de imprensa sobre a implementação dos regulamentos MDR/IVDR. Defendem várias medidas para garantir uma implementação efectiva.

Em 29 de outubro de 2024, o Grupo de Coordenação dos Dispositivos Médicos (MDCG) publicou o documento “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) for sterilization of medical devices”.

Este documento aborda a aplicação de EtO durante o fabrico de dispositivos médicos e em instituições de cuidados de saúde para esterilizar dispositivos antes ou depois da sua utilização.

O mais recente documento de orientação MDCG 2022-5 Rev. 1 é um recurso fundamental para as partes interessadas que trabalham ao abrigo do Regulamento (UE) 2017/745.

Elaboradas pelo Grupo de Coordenação dos Dispositivos Médicos (MDCG) e aprovadas por representantes de todos os Estados-Membros da UE, estas orientações têm por objetivo clarificar a distinção, por vezes matizada, entre dispositivos médicos e medicamentos.