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US FDA News!! (FDA – Quality Management System Regulation) The FDA has published (31-Jan) the “Quality Management System Regulation final rule”This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The rule renames the regulation to the Quality Management System Regulation (QMSR). The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026. FDA will develop a new inspection process to align with the requirements of the new Quality Management System Regulation (QMSR). The process will be developed for implementation when the rule takes effect. Know more about our Quality Management System (QMS) regulatory services at https://lnkd.in/dt4tQYNy

Important Update in EU Medical Device Regulation MDCG 2024-1-2 Guidance on the Vigilance System for CE-marked Devices (DSVG) 02 Coronary Stents and associated delivery systems. January 2024. The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Coronary Stents and associated delivery systems. It provides further clarification for vigilance reporting of Coronary Stents and associated delivery systems to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR). This DSVG does not replace or extend any of those requirements. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, in accordance with Articles 87 and 88 MDR, which occurred with Coronary Stents and associated delivery systems to the relevant Competent Authority. Know more about our Post Market Surveillance (PMS) services at https://lnkd.in/dt4tQYNy

Instituto Pedro Nunes Automatics and Systems Lab has achieved ISO 13485 certification, reinforcing our commitment to excellence and quality in the medical devices industry. ISO 13485 certification demonstrates our adherence to the highest standards of quality management systems specifically designed for manufacturers and suppliers of medical devices. This certification also aids our ability to consistently provide services that fulfill regulatory requirements and exceed customer expectations We look forward to continuing our mission of making a positive impact on the healthcare sector.

Important Update in EU Medical Device Regulation MDCG 2024-1-3: Guidance on the Vigilance System for CE-marked Devices (DSVG) 03: Cardiac Implantable Electronic Devices (CIEDs). January 2024. The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Cardiac implantable electronic devices and their leads (CIEDs). It provides further clarification for vigilance reporting of Cardiac implantable electronic devices and their leads (CIEDs) to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR). This DSVG does not replace or extend any of those requirements. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, in accordance with Articles 87 and 88 MDR, which occurred with Cardiac implantable electronic devices and their leads (CIEDs) to the relevant Competent Authority. Know more about our Post Market Surveillance (PMS) services at https://lnkd.in/dt4tQYNy

Important Update in EU Medical Device Regulation MDCG 2024-1-4: Guidance on the Vigilance System for CE-marked devices DSVG 04: Breast Implants. January 2024. The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Breast Implants. It provides further clarification for vigilance reporting of Breast Implants to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR). This DSVG does not replace or extend any of those requirements. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, in accordance with Articles 87 and 88 MDR, which occurred with Breast Implants to the relevant Competent Authority. Know more about our Post Market Surveillance (PMS) services at https://lnkd.in/dt4tQYNy

The U.S. Food and Drug Administration (FDA) is issuing a critical warning regarding the use of smartwatches or smart rings to measure blood glucose levels without piercing the skin. Despite claiming to provide blood glucose readings, these devices have no FDA authorization, clearance, or approval for this purpose. As MDRu is a unit dedicated to the regulatory support of medical devices for various markets, including FDA approval, we emphasize the paramount importance of using devices that are properly certified and approved by competent authorities. Like the FDA, we strongly advise against the use of smartwatches or smart rings to measure blood glucose without piercing the skin. The use of these unapproved devices can result in significant errors in diabetes management, potentially leading to dangerously low glucose levels and serious health complications. If you have a product that requires FDA approval or are looking for guidance on regulatory issues, please do not hesitate to contact us or visit our website: https://lnkd.in/dPbMTdSs Let’s ensure the safety and efficacy of medical devices together.

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