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Are you a medical device manufacturer in Portugal? This is important news for you! The recent publication of Decree-Law 29/2024 transposes Regulation (EU) 2017/745 on medical devices into Portuguese law and includes the following topics: – Legal obligations of economic agents;– Applicable sanctions;– Information and notification obligations;– Requirements relating to manufactured devices and their use in healthcare institutions; Link of Decree-Law n° 29/2024: https://lnkd.in/dBisP4Hp Find out more about how this Decree-Law could affect your business or book a meeting with us: https://lnkd.in/dPbMTdSs

Sandra Balseiro and João Quintas participated on the Webinar: Understanding Medical Devices Regulation. This event was an opportunity to deepen knowledge of medical device regulation. Sandra Balseiro covered the essential steps required for CE marking, highlighting key milestones and outlining the necessary procedures for obtaining CE marking on medical devices and in vitro diagnostics. João Quintas discussed technical and usability requirements according to the MDR, using case studies of ORACIA and FaceRehab to illustrate real-world applications and challenges under the Medical Devices Regulation. In addition, Célia Ludovino, from BHL-Medical, Indústria de Produtos Hospitalares, Lda, shared her success story in the transition from Directive 92/43/EC to European Regulation 2017/745. And Ana Abreu, from Kinetikos Health, provided insights about her experience of mastering European Regulation 2017/745 for the first time. Don’t miss this learning and networking opportunity! Join us at Medical Devices Regulatory — support unit (MDRu) and let’s explore the world of medical device regulation together: https://lnkd.in/dt4tQYNy

Sandra Balseiro, Head of the Medical Devices Regulatory — support unit, was a speaker on the webinar “Development of the Researcher’s Brochure: Medical Devices and In Vitro Diagnostic Medical Devices” organized by AICIB – Agência de Investigação Clínica e Inovação Biomédica. Sandra shared valuable insights on the nuances of the Investigator’s Brochure for In Vitro Diagnostic Medical Devices, offering practical guidance on navigating regulatory requirements and ensuring compliance. Are you interested in upcoming events? Stay connected to our LinkedIn page for updates on opportunities to enhance your knowledge of medical device regulation and development. Know more about MDRu at https://lnkd.in/dt4tQYNy

Medical Devices Update: discover fresh insights from the latest study on the implementation of Article 17 of Regulation (EU) 2017/745 concerning medical devices in the EU market. This article governs the reprocessing of single-use devices in the EU market, assessing its implementation across 30 European countries. Key Findings: Unveil challenges and opportunities, from certification processes to sustainability benefits. Actionable Recommendations: Equip stakeholders with steps to enhance Article 17 implementation. Let’s collaborate to optimize regulation, fostering innovation and safety. Schedule a meeting with us! Read the Full Report here: https://lnkd.in/dBisP4Hp Know more about how to implement the Art. 17 of MDR into your health institution at: https://lnkd.in/dt4tQYNy

Medical Devices Update – MDCG 2024-4: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746, April 2024. – Studies must follow reporting rules set by Article 76 of Regulation (EU) 2017/746;– Sponsors must report serious adverse events, device deficiencies that could have caused harm, and any new findings related to these;– Reports go to all involved countries through a specific electronic system (Eudamed);– There are different reporting requirements for studies on already marketed devices;– This guidance document provides alternative reporting procedures until the Eudamed system is fully functional. Read the full document here: https://lnkd.in/dkxxX5Pf Know more about how to conduct safety reporting in performance studies of IVDs at Medical Devices Regulatory — support unit: https://lnkd.in/dt4tQYNy

News from the European Commission! Delve into the latest advancements in Artificial Intelligence (AI) integration within scientific research across Europe. Dive into the details of Scientific Opinion No. 15, a comprehensive report by the European Commission’s Group of Chief Scientific Advisors (GCSA). This document was prepared at the request of two European Commissioners to explore the successful and timely use of Artificial Intelligence (AI) in scientific research across Europe. Led by a team of three scientific advisors and endorsed by all seven GCSA members, this report highlights the collaborative efforts of various entities. From the contributions of the Science Advice for Policy by European Academies (SAPEA) consortium to the support provided by the European Commission’s team and expert contributors, this endeavor embodies a collective commitment to innovation. Find out more about how Medical Devices Regulatory — support unit (MDRu) can help you use AI in the field of medical devices at: tps://lnkd.in/dt4tQYNy

📢 Medical Devices Update: New Guidelines for Medical Device Labeling! 🌐 The International Medical Device Regulators Forum (IMDRF) has released a new document outlining the principles of labeling for medical devices, including those for in-vitro diagnostics (IVDs). 👉 This document aims to standardize the content and format of medical device labeling, which can be presented in paper or electronic form. It covers general labeling principles and includes specific sections on the label itself, instructions for use, and patient information. 👉 It’s important to note that this document provides general guidelines and doesn’t cover everything. Manufacturers should also consider the requirements of any relevant medical device or IVD medical device-specific standards. Additionally, advertising and promotional materials are not included in the scope of this document, and individual regulatory authorities may have their own requirements for these elements. 💡 This new guidance promotes clear and consistent labeling for medical devices worldwide, which can ultimately improve patient safety and device use. 🔎 Know more about our expertise for medical devices and IVDs labeling at: https://lnkd.in/dt4tQYNy

The International Medical Device Regulators Forum (IMDRF) has just released a new final document! This latest document, IMDRF/GRRP WG/N71, is part of a series aimed at streamlining the regulatory approval process for medical devices. Building upon existing guidelines, it focuses on the crucial aspect of regulatory review reports. By specifying the information that should be included in these reports, IMDRF/GRRP WG/N71 ensures a standardized approach across regulatory jurisdictions. This not only promotes efficiency but also enhances collaboration between review bodies and regulatory authorities. At Medical Devices Regulatory — support unit (MDRu) we understand the importance of staying up-to-date with regulatory updates like IMDRF/GRRP WG/N71. Visit our website to learn more about how we can assist you in navigating these changes and ensuring compliance with regulatory requirements: https://lnkd.in/dt4tQYNy Let’s work together to drive innovation while maintaining the highest standards of safety and performance in the medical device industry!

A quick look back at our recent webinar “Software as a Medical Device and the Regulatory Implications of AI,” where Sandra Balseiro and Ana Brito shared their expertise:Sandra Balseiro delved into European Regulation for Software as a Medical Device, providing strategic insights to streamline the regulatory approval process.Ana Brito shared her experience and valuable insights about European Regulation and the AI ACT.Also, Eduardo Barbosa and Inês Lopes transmitted the good practices for software as a medical device and AI softwareAdditionally, Miguel Mascarenhas, CEO of DIGESTAID – Digestive Artificial Intelligence Development, present “The real set case of DIGESTAID – Digestive Artificial Intelligence Development.”Thank you to all our speakers and participants for an enriching discussion!

Exciting News! The new version of EUDAMED 3.8.0 has been deployed! For all the details on what’s new and improved in this release, check out the full release note document available at the EUDAMED Information Centre – EUDAMED (playground). Read the full release note: EUDAMED release note (v3.8) The MDRu can help you navigate these updates and ensure your compliance. Visit our website to learn how we can support your regulatory needs and keep your medical devices market-ready. Visit our website: https://lnkd.in/dreiWTp7