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The FDA’s draft guidance on pulse oximeters provides critical recommendations for non-clinical and clinical performance testing, addressing concerns about factors such as skin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.

The FDA's updated guidance for the Global Unique Device Identification Database (GUDID) introduces essential changes for medical device manufacturers. Released on December 17, 2024, this revised guidance replaces the 2014 version, focusing on compliance with UDI regulations and enhancing the submission process. Key updates include the shift to GMDN codes as the standard for device identification, ensuring global harmonization and simplifying classification and registration. Additional improvements feature enhanced validation rules and a streamlined user interface for GUDID submissions, minimizing errors and optimizing workflows. This guidance strengthens the system for device tracking, crucial for regulatory compliance and global market access strategies. Staying aligned with these changes is critical for manufacturers to ensure seamless operations and maintain a competitive edge.

The EU medical device and IVD regulations are undergoing a comprehensive evaluation through the European Commission public consultation, open until March 21, 2025. This initiative aims to assess the effectiveness of the current medical device regulatory framework in ensuring safety and innovation while addressing key challenges faced by SMEs and fostering improved market access. Stakeholders are encouraged to share insights on critical issues, such as the availability of orphan devices, the impact of IVD regulations, and the need for streamlined processes to support a competitive and evolving healthcare innovation landscape in the EU.

Explore the latest advancements in IVDR compliance for Class D IVDs, including the Multi-Services Agreement (MSA) for harmonized verification by Notified Bodies and EURLs. Learn how streamlined processes enable faster approvals and market access.

The European Commission's Regulation (EU) 2024/1860 introduces critical updates to EU medical device regulations, including the gradual implementation of Eudamed, a central database to enhance the traceability and safety of medical devices and IVDs. These updates aim to ensure supply chain continuity by mandating manufacturers and suppliers to promptly notify healthcare professionals and authorities about any supply disruptions or discontinuations. Transitional provisions for certain IVDs provide a smoother compliance path under the amended MDR and IVDR frameworks, reducing the risk of device shortages while maintaining healthcare product availability and improving market transparency.

The recently released MDCG 2024-16 introduces the Manufacturer’s Information Form, a critical step toward enhancing transparency and communication regarding medical device supply interruptions and discontinuations in the European market. This form ensures that manufacturers notify authorities, healthcare professionals, and other stakeholders about potential supply issues, supporting patient safety and regulatory compliance. By enabling timely notifications, it allows healthcare providers and distributors to adapt their supply chains and maintain access to essential medical devices and IVDs. These updates strengthen the EU’s medical device regulatory framework, emphasizing efficiency and safety while mitigating risks of device shortages.

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.