Luís Fardilha

EU MDR/IVDR Update!! The Medical Devices Harmonised Standards have been updated with the two implementing decisions published by the European Commission. “Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products.” It includes the following entries to the list of standards: EN 455-3:2023; EN ISO 10993-15:2023; EN ISO 10993-17:2023; EN ISO 10993-18:2020; EN ISO 11137-2:2015; EN ISO 11607-1:2020; EN ISO 11607-2:2020; EN ISO 17664-2:2023. “Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices.” It includes the following entries to the list of standards: EN ISO 11137-2:2015; EN ISO 11607-1:2020; EN ISO 11607-2:2020. Decision (EU) 2024/815: https://lnkd.in/eiARD-a2Decision (EU) 2024/817: https://lnkd.in/eGe2piuU Know more about our Medical Devices Harmonised Standards expertise at https://lnkd.in/dt4tQYNy

MDCG NEWS! MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) This guidance document has been written to support sponsors developing their Clinical Investigation Plan (CIP) by describing in greater detail what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. Moreover, a CIP with the appropriate content will be instrumental in the conduct of the clinical investigation. Know more about our Clinical Investigations expertise at https://lnkd.in/dt4tQYNy

The European Parliament has given the green light to the EU AI Act! But what does this mean? The regulation awaits the final review and adoption before the legislative session ends, with Council endorsement still to come. Once published, it activates in just 20 days, but full implementation won’t happen overnight – we’ve got a timeline: prohibited practices are out in 6 months, followed by codes of practice in 9, general AI rules in 12, and high-risk system obligations in 36 months. Why is this important? The approval of the EU AI Act represents a key step in aligning technological progress with the protection of fundamental rights. It highlights the EU’s dedication to setting standards in ethical AI practices, offering a model for responsible innovation and providing a reference framework for other regions. Curious about our expertise in AI within the Medical Devices field? 💡 Dive deeper at our site: https://lnkd.in/dreiWTp7

FDA paper alert! Dive into the future of healthcare with the FDA’s latest paper on “Artificial Intelligence & Medical Products.” Artificial intelligence has the potential to transform medical product development, enhancing patient care, and empowering healthcare professionals. The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) are joining forces in this paper to ensure public health is protected while promoting ethical innovation. Interested in our AI expertise within the FDA regulation context? Discover more at medicaldevices.ipn.pt

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