Luís Fardilha

O Instituto Pedro Nunes (IPN) e a Nova Medical School (NMS) estabeleceram uma parceria para fortalecer a capacidade das instituições em atrair novos parceiros ou clientes para os seus serviços na área dos dispositivos médicos. Para divulgar o funcionamento desta parceria junto da indústria, decorreu, no dia 28 de junho de 2024, um evento único em Portugal para explicar às empresas a jornada que envolve o desenvolvimento de dispositivos médicos ou IVD, até à comercialização. Este evento serviu também para demonstrar a funcionalidade dos parceiros (IPN, NMS e TUV-SU) às empresas. A TUV-SUD é o organismo notificado europeu de relevância na certificação de dispositivos médicos com marcação CE. Através da NOVA CRU, a NMS apoia empresas e startups durante a fase de investigação clínica, com os seguintes serviços: desenho e planeamento da investigação clínica/estudo de desempenho, desenvolvimento do protocolo de investigação clínica, preparação e submissão de ensaios ou estudos clínicos (EC) às autoridades competentes, monitorização e gestão, análise de dados, tecnovigilância, e construção de softwares informáticos que respondam às especificidades da Investigação Clínica. O IPN, através da sua Unidade Regulamentar de Dispositivos Médicos, oferece serviços especializados em regulamentação e conformidade, auxiliando empresas a navegar pela jornada regulamentar, que é necessária para o desenvolvimento e comercialização de novas tecnologias.

Attention IVD manufacturers! There’s important news regarding EU MDR/IVDR compliance deadlines. On July 9th, 2024, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU). This new regulation offers some key benefits for IVD manufacturers: Extended Transition Periods:– Class D devices now have until December 31st, 2027, to comply.– Class C devices have an extended deadline of December 31st, 2028.– Class B devices and sterile Class A devices have until December 31st, 2029. Phased Rollout of EUDAMED: The new EUDAMED electronic database will be implemented gradually. Improved Supply Chain Transparency: Manufacturers will be required to report potential shortages of critical devices and IVDs. This is great news for IVD manufacturers facing challenges meeting the initial deadlines. These extensions provide valuable time to ensure compliance. Here are some key dates to remember:– Regulation enters into force: Upon publication in the OJEU (July 9th, 2024)– Obligations for interruption/discontinuation reporting: January 10th, 2025 Don’t miss out on these extended deadlines! Review Regulation (EU) 2024/1860 and ensure a smooth transition for your IVD products. Medical Devices Regulatory — support unit (MDRu) can help you comply with Regulation (EU) 2024/1860. Contact us now: https://lnkd.in/dreiWTp7

Attention medical device manufacturers! The Medical Devices Regulatory — support unit (MDRu) informs you about the publication of the new Regulation (EU) 2024/1860, which brings important changes to the sector. Main changes:– Gradual implementation of EUDAMED: The EUDAMED platform will be implemented gradually, with specific deadlines for different types of devices.– Obligation to inform in the event of interruption or discontinuation of supply: Manufacturers are now obliged to inform the competent authorities and distributors in the event of interruption or discontinuation of supply of their products.– Transitional provisions for certain in vitro diagnostic medical devices: Class A and B in vitro diagnostic devices will have different deadlines to comply with the new rules. MDRu can help you understand and adapt to the new requirements of Regulation (EU) 2024/1860. Contact us today to find out more about how we can help you ensure the compliance of your medical device: https://lnkd.in/dreiWTp7

The Medical Device Coordination Group (MDCG) has released an updated version of the Guidance on Classification Rules for in vitro Diagnostic Medical Devices (IVDs) under Regulation (EU) 2017/746. This revised guidance, MDCG 2020-16 Rev.3, provides clarifications and updates to assist manufacturers in correctly classifying their IVDs. Key Changes in MDCG 2020-16 Rev.3: – Enhanced clarity on classification rules: The guidance provides more detailed explanations and examples to help manufacturers determine the appropriate risk class for their IVDs.– Updated information on borderline and classification issues: The guidance addresses recent developments and clarifications regarding borderline cases and classification disputes.– Improved guidance on the application of Annex VIII: The guidance provides more specific instructions on how to apply the Annex VIII classification rules to various IVD types. Why is this update important? – Accurate classification is crucial: Proper classification ensures that IVDs undergo the appropriate conformity assessment procedures and are subject to the correct regulatory requirements.– Reduced risk of non-compliance: By following the updated guidance, manufacturers can minimize the risk of non-compliance and potential market restrictions.– Facilitated market access: Accurate classification can expedite the market authorization process for IVDs.The Medical Devices Regulatory — support unit (MDRu) of Instituto Pedro Nunes is here to assist you with understanding and applying the MDCG 2020-16 Rev.3 guidance. Feel free to contact us for further information: https://lnkd.in/dreiWTp7

The MDCG has released a revised document (MDCG 2021-5 Rev. 1) offering guidance on using standards to comply with EU medical device regulations. This document covers key areas like:– EU Legislation & Standards: Explains the role of harmonized European standards in supporting the “New Approach” and “New Legislative Framework” for medical devices.– Voluntary Use & Legal Weight: Clarifies the voluntary nature of using standards while also highlighting the presumption of conformity granted by published harmonized standards.– Standards Development & Governance: Provides insights into the development process for harmonized standards and the role of the MDCG Subgroup on Standards. Note: This is a non-exhaustive summary and should be read in conjunction with the full document and relevant legal frameworks. Find out more about our harmonized standards expertise at: https://lnkd.in/dreiWTp7

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