Notícias

The Medical Device Coordination Group (MDCG) published a new document on June 25th titled “MDCG 2024-10 “Clinical evaluation of orphan medical devices”. This guidance aims to assist manufacturers and notified bodies in evaluating orphan medical devices (ODs) and devices with orphan indications under the MDR (EU Regulation 2017/745). The document offers a two-part approach:– Part A: This section focuses on clinical considerations for orphan devices. It addresses limitations in pre-market data that may be acceptable, key factors for evaluation, and strategies for generating post-market data.– Part B: This part guides notified bodies on assessing orphan devices and the role of expert panels in the process. Three appendices provide additional resources:– Appendix A: Specific guidance on clinical evaluation reports for orphan devices.– Appendix B: Guidance on clinical investigations for orphan devices.– Appendix C: Guidance on extrapolating clinical data for orphan indications. This new guidance clarifies the clinical evaluation process for orphan medical devices, potentially improving market access for these essential but niche technologies. Find out more about our experience with MDCG guidelines at: https://lnkd.in/dreiWTp7

This guide helps small entities navigate the new regulatory landscape for LDTs, as outlined in the recent LDT Final Rule. The rule clarifies that LDTs fall under the FDA’s oversight, ensuring patient safety and test accuracy. Find out more about our LDTs expertise at: https://lnkd.in/dreiWTp7

Instituto Pedro Nunes, through its Medical Devices Regulatory — support unit team, in collaboration with NOVA Clinical Research Unit (NOVA CRU) organized the event “Marketing Your Medical Device: A Comprehensive Journey Through Regulatory Compliance and Clinical Evaluation” in Lisbon. This event provided a unique opportunity for participants to connect with TÜV SÜD Italy’s leading MDR and IVDR auditors and deepen their knowledge of the regulatory landscape.We had a panel of experts in the field of medical devices and in vitro diagnostics such as– Ana Brito (MDRu) presented the steps to CE marking– Carlo Gherardi (TUV SUD Italy) covered pre-clinical testing– Sandra Balseiro (MDRu) gave insights into clinical and performance evaluation– Lúcia Domingues and Catarina Silvério (NOVA-CRU) spoke about clinical investigations and safety for medical devices– Francesca Bevilacqua (TUV SUD Italy) discussed the process of reference laboratories for IVDs– Agnese Mengoli (TUV SUD Italy) covered the submission process for notified bodies– Célia Ludovino, Mariana E. Reis, and José Leovigildo Coelho spoke about the success cases of BHL-Medical, Indústria de Produtos Hospitalares, Lda, C-mo Medical Solutions and IONIC Health respectively. Special thanks to Stefano Bolletta Bolle from TUV SUD and Rita Rocha from NOVA-CRU. This event highlighted the importance of regulatory compliance and clinical evaluation for the success of medical devices and in vitro diagnostics. We are committed to continuing to promote events that drive knowledge and innovation in healthcare.

The European market prioritizes the safety and efficacy of medical devices. The MDR (EU Regulation 2017/745) governs the entire lifecycle of these devices in Europe, ensuring they function as intended and minimize risks.Achieving MDR Compliance: The Role of StandardsFollowing EU-harmonized standards published in the Official Journal of the European Union is a recommended approach for MDR compliance. These standards provide a roadmap for essential aspects of medical device development. Standards for Risk Management and Biological Evaluation:– EN ISO 14971 outlines a comprehensive risk management process for medical devices.– EN ISO 10993-1 defines biological evaluation and testing within the risk management process. It emphasizes a case-by-case approach, considering factors like contact duration and body part contact to determine appropriate biological evaluation methods. Additional EN ISO 10993 standards delve deeper into specific tests for various biological evaluation endpoints. For instance:– EN ISO 10993-17 and 18 guide toxicological risk assessment and material characterization.– Furthermore, device-specific and clinical investigation standards might also be relevant. By adhering to these standards, manufacturers can promote the safety and effectiveness of their medical devices in the European market. Special Considerations for CMR/ED Phthalates– The MDR restricts the use of certain phthalates, known as CMR/ED phthalates, due to potential health concerns.– Manufacturers should prioritize alternatives whenever possible.– If using a restricted phthalate is essential, a justification based on a thorough risk-benefit analysis is required.– Following these regulations and standards is crucial for ensuring patients have access to safe and effective medical devices. Want to learn more? Our experts can provide further insights into these updates. Check out the tour site at https://lnkd.in/dreiWTp7.

The US FDA, Health Canada, and UK MHRA released a new document today: “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles.” This builds on the 2021 Good Machine Learning Practice (GMLP) principles, providing additional considerations for developers and regulators on ensuring transparency in AI-powered medical devices. These principles are key for fostering trust and responsible development in this rapidly evolving field. Find out more about MDRu at: https://lnkd.in/dreiWTp7

MDRU attended the Hospitalar 2024, in Brazil, a renowned Hospitalar trade fair!We are dedicated to advancing the medical device and IVD sector through comprehensive regulatory support. Our presence at the fair allowed us to engage directly with Brazilian companies eager to expand their business into Europe.We are committed to bridging the gap between markets by providing regulatory assistance to both Brazilian companies aiming to enter the European market and European companies looking to bring their innovations to Brazil.Discover how MDRu can support your business by visiting our website: https://lnkd.in/dt4tQYNy

Medical Devices Update: Council adopts new measures to help prevent shortages! The European Council recently updated regulations on medical devices to address potential shortages and improve transparency. These changes aim to strike a balance between ensuring device safety and facilitating market access. Firstly, the transition period for certain in-vitro diagnostic medical devices (IVDs) has been extended. This ensures continued availability of critical IVDs while new safety regulations are implemented. Secondly, the rollout of the European database on medical devices (EUDAMED) will be gradual. Manufacturers can begin registering devices in existing modules without waiting for the entire system to be complete. Full mandatory registration is expected by late 2025. Finally, manufacturers are now required to provide advanced notice of potential supply disruptions for critical medical devices and IVDs. This will allow relevant authorities and healthcare providers to prepare and potentially mitigate shortages. Visit our website to find out how we can help you to be compliant in this field: https://lnkd.in/dreiWTp7

EU gives final green light to the first worldwide rules on AI 📢The EU Council has approved the Artificial Intelligence (AI) Act, establishing the world’s first comprehensive AI rules. This landmark legislation uses a risk-based approach, imposing stricter regulations on high-risk AI to protect society and fundamental rights.Key Points:– Risk-Based Regulation: Stricter rules for higher-risk AI systems.– Fundamental Rights: Ensures AI respects EU citizens’ rights.– Governance: New bodies to enforce and support AI rules.– Innovation Support: Regulatory sandboxes for testing AI systems.– Transparency: Mandatory impact assessments and registration for high-risk AI. Read more here: https://lnkd.in/dfZqbE_j At MDRu we can help you with the AI Act, see how through the website: https://lnkd.in/dreiWTp7

A quick look at the webinar ‘Mastering the Clinical Evaluation of Medical Devices’, which took place last week! Sandra Balseiro and Celeste Oliveira, from MDRu, provided an in-depth understanding of the regulatory requirements for clinical evaluation. Insights from the CRO, NOVA Clinical Research Unit (NOVA CRU), helped attendees navigate the clinical evaluation process. In addition, João Leite shared Insparya Portugal‘s first-hand experience. This was the third in a series of webinars designed to enhance knowledge of medical device regulations: “Understanding Medical Devices Regulation”, “Software as a Medical Device and the Regulatory Implications of AI”, and “Mastering the Clinical Evaluation of Medical Devices.”

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