news

📌 This comprehensive document highlights key common pitfalls that often delay assessments and provides essential recommendations to ensure your submissions are clear, consistent, and aligned with regulatory expectations. Good examples include: 🔍 Best practices for structuring documentation;🧩 Enhanced consistency and alignment across all documentation;🔗 Clear rationale for GSPR applicability and conformity demonstration strategy;📄 Insightful recommendations for risk management activities; 📂 Improved evidence management throughout the entire technical documentation. 👉 If you’re involved in regulatory compliance for medical devices, this is a must-read to streamline your certification journey and better collaborate with Notified Bodies. 📄 The full paper is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.

🚨 The European AI Act is here – and it brings new challenges for AI-based medical devices! 🎯 Key highlights from the paper: 📆 The high-risk scope under article 6(1)(AIA) will apply starting August 2, 2027 🛡️ Strong emphasis on fundamental rights like privacy, data protection, non-discrimination, and human dignity🔍 Critical definitions: AI system, safety component, substantial modification and significant change🏛️ Urgent need for designation of AI-ready Notified Bodies🔁 Risks associated with overlapping requirements between MDR/IVDR and the AI Act 💡 The message is clear: a harmonised, pragmatic approach is needed to ensure that innovation in healthcare is not delayed, and that stakeholders are prepared for the regulatory convergence of AI and medical technology. 📄 The full paper is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.

Instituto Pedro Nunes (IPN) and NOVA Medical School – Faculdade de Ciências Médicas (NMS) have established a partnership to strengthen the institutions’ ability to attract new partners or clients for their services in the field of medical devices. To promote the partnership among the industry, a unique event in Portugal was held on 28 June 2024 to explain to companies the journey involved in developing medical devices or IVDs, right through to commercialisation. The event also served to demonstrate the functionality of the partners (IPN, NMS and TUV-SU) to companies. TÜV SÜD is the leading European notified body for the certification of CE-marked medical devices. Through NOVA CRU, NMS supports companies and start-ups during the clinical research phase, with the following services: design and planning of the clinical research/performance study, development of the clinical research protocol, preparation and submission of clinical trials or studies (CS) to the competent authorities, monitoring and management, data analysis, technovigilance, and construction of computer software that responds to the specificities of Clinical Research. IPN, through its Medical Devices Regulatory — support unit, offers specialised regulatory and compliance services, helping companies navigate the regulatory journey that is necessary for the development and commercialisation of new technologies.

Attention healthcare innovators! Ready to spearhead change in the healthcare sector? The EIT Health Regulatory Pathways to Market Bootcamp is your ticket to success! With 8 hours of mentoring with experts and 60 hours of immersive content, this bootcamp offers an opportunity to tackle regulatory challenges and accelerate your company’s growth. The top 10 ranked companies will receive an exclusive 50% discount on participation fees!

Important Update in EU Medical Device Regulation In January 2024, the medical device community is greeted with updated guidance from the Medical Device Coordination Group (MDCG). The latest release, MDCG 2024-1-2, specifically focuses on the vigilance system for CE-marked devices, with a keen eye on Coronary Stents and their associated delivery systems under DSVG 02. Know more about our Post Market Surveillance (PMS) services at https://lnkd.in/dt4tQYNy

Instituto Pedro Nunes‘ Medical Devices Regulatory — support unit participated in the presentation of TEF-Health and DigiHealthPT projects and their respective service catalogues, in Lisbon.Through these projects, our team specializes in assisting SMEs and start-ups with regulatory compliance and supporting the certification of medical devices, IVDs, and medical software. We understand the complexities of regulatory requirements and are committed to supporting you throughout the process, ensuring your innovations reach the market quickly and efficiently.TEF-Health aims to build TEF (Testing and Experimental Facilities) structures, establishing a vital link between companies and hospitals. As well as providing environments for testing and demonstrating solutions, the TEFs will facilitate ethical and data protection reviews, integrating activities such as incubation and market analyses.DigiHealthPT is a Digital Innovation Hub, part of the European DIH Network, which focuses on the application of Artificial Intelligence and Cybersecurity in Health to respond to the emerging needs of startups, SMEs, and the public sector, supporting digital innovation and promoting the adoption of digital solutions.

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