INNOMedX’s Post

🚨The European Parliament has approved a Proposal to extend the transitional measures for IVD legacy devices and includes agradual implementation of the EUDAMED database,and establish a notification system for supply disruptions of critical medical devices:   Key points: ♦Extension of transitional period: Class D: Deadline extended to December 2027 Class C: Deadline extended to December 2028 Classes B & A: Deadline extended to December 2029 ♦EUDAMED Database: A phased implementation of the EUDAMED database is proposed to enhance transparency and oversight of medical devices in the EU. ♦Notification System: The introduction of a notification system for supply disruptions is proposed to alert about potential shortages of critical in vitro diagnostics and medical devices, ensuring timely responses and continuity in patient care.   #Healthcare #MedicalDevices #InVitroDiagnostics #EURegulations #PatientSafety #Eudamed #Innovation #EuropeanUnion

Switzerland News!! (Obligations for Economic Operators in Switzerland) Swissmedic has announced an updated "Information Sheet titled Obligations for Economic Operators CH" reflecting the latest changes following the amendment to the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). This document describes the obligations and transitional provisions applicable to economic operators established in Switzerland and to devices that are made available on the market in Switzerland. This update is a direct result of the amendment to the IvDO, which introduces extended transitional periods and more time for healthcare institutions to meet compliance requirements for in-house products. The new notification obligation according to Article 10a EU-MDR and EU-IVDR, under which the manufacturer must provide notification of interruption or discontinuation of the supply of certain medical devices is not part of this revision of the Swiss ordinances. In the absence of a Swiss-EU Mutual Recognition Agreement (MRA), Switzerland implemented measures in 2021 to mitigate the impact of not accessing the EU database (Eudamed) and lacking market monitoring cooperation. These measures include: •Appointing an authorized representative ("CH-REP") •Registering economic operators with Swissmedic •Reporting serious incidents to Swissmedic •Recognizing EU certificates of conformity in Switzerland For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevice #medicaldevices #surveillance #clinicaltrials #automation #regulatoryintelligence #fda #medtech #ivdo #mdr #ivdr

🚨 Laboratory Developed Tests: Understanding Regulation (European Union) 2017/746 on In Vitro Diagnostic Medical Devices 🚨 As of April 5, 2017, the European Parliament and Council have implemented REGULATION (EU) 2017/746, superseding Directive 98/79/EC and Commission Decision 2010/227/EU. This regulation sets forth stringent requirements for in vitro diagnostic medical devices (IVDs), explicitly targeting devices manufactured and used exclusively within health institutions across the European Union. 🔬 Key Highlights: - Laboratory Developed Tests (LDTs): Health institution laboratories must comply with EN ISO 15189 standards or relevant national provisions, including those for accreditation. - Transparency and Accountability: Health institutions are required to provide detailed information upon request to their competent authorities. This includes a thorough justification for the manufacturing, modification, and usage of such devices. This regulation underscores the importance of maintaining high standards and transparency in the use of IVDs within health institutions, ensuring patient safety and the reliability of diagnostic results. For further details, see Chapter III - Article 5 Placing on the market and putting into service, paragraph 5 . 📣 How is your lab preparing to comply with Regulation (EU) 2017/746, and what challenges have you encountered in implementing these standards? Regulation (EU) 2017/746: https://lnkd.in/dsCX3VYw #IVD #MedicalDevices #HealthcareRegulation #EUCompliance #ISO15189 #LaboratoryDevelopedTests #LDT

🚨 EU Parliament Votes to Revise MDR and IVDR On October 23, the European Parliament adopted a resolution to address ongoing challenges with the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). While non-binding, the resolution calls for critical updates, including: ✅ Streamlining certification processes to prevent product shortages ✅ Supporting innovation with fast-track approvals for life-saving technologies ✅ Reducing regulatory burdens for SMEs These proposed changes aim to balance patient safety, innovation, and accessibility—but the timeline and implementation details remain unclear. What’s next? The resolution is a reminder for stakeholders to collaborate and find flexible, targeted solutions. As the EU Commission evaluates next steps, the focus must remain on improving patient outcomes without compromising safety or innovation. 📖 Explore our latest blog for an in-depth analysis: https://lnkd.in/eHjWfKn5 #MDR #IVDR #MedTech #RegulatoryAffairs #EURegulations #Innovation

During a House Health Subcommittee hearing, FDA leaders faced tough questions about delays in medical device approvals and missteps in regulatory processes. Lawmakers expressed concerns about the slow approval of innovative devices, regulatory burdens on laboratory-developed tests (LDTs), and the need for improved communication with applicants. They also discussed the importance of a third-party certification model for AI/ML-enabled devices and the FDA's efforts to streamline innovation through programs like the Breakthrough Devices Program. FDA officials acknowledged challenges and sought congressional support for needed reforms. https://lnkd.in/dWh8EvvC #healthcare #healthcareinnovation #healthcareit #healthcareai #ai #medicaldevices

📌 Breaking Regulatory News | European Commission's Proposal on In Vitro Diagnostic Medical Devices Regulation and EUDAMED Roll-Out 📅 Timeline of the Proposal: 𝗝𝗮𝗻 𝟮𝟯, 𝟮𝟬𝟮𝟰: European Commission introduces crucial proposal on #IVDs & #EUDAMED. 𝗝𝗮𝗻 𝟯𝟬, 𝟮𝟬𝟮𝟰: Proposal presented to Council's Working Party. 𝗙𝗲𝗯 𝟭𝟰, 𝟮𝟬𝟮𝟰: Committee of Permanent Representatives (#Coreper) consents to proposal text, advancing negotiations. 𝗙𝗶𝗹𝗲 𝗮𝘀𝘀𝗶𝗴𝗻𝗲𝗱 𝘁𝗼 #𝗘𝗡𝗩𝗜 committee in European Parliament. 🗳️ Expected Developments: 𝗧𝗼𝗱𝗮𝘆: April II plenary session, 𝗣𝗮𝗿𝗹𝗶𝗮𝗺𝗲𝗻𝘁 𝗵𝗮𝘀 𝘃𝗼𝘁𝗲𝗱 ‘𝗬𝗘𝗦’ on the Commission's proposal (Rule 163). 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁 𝗿𝗲𝗮𝗰𝗵𝗲𝗱: If #Parliament adopts original proposal, #Council will endorse. 🔍 Key Proposal Amendments: 𝗜𝗻 𝗩𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (#𝗜𝗩𝗗𝗥): Proposal extends transition periods to aid compliance. 𝗘𝗨𝗗𝗔𝗠𝗘𝗗 𝗥𝗼𝗹𝗹-𝗢𝘂𝘁: Phased implementation of the #electronicsystems within the #European database on #medicaldevices (‘Eudamed’) suggested for smoother transition. 𝗠𝗮𝗻𝗱𝗮𝘁𝗼𝗿𝘆 𝘂𝘀𝗲 of several 𝗺𝗼𝗱𝘂𝗹𝗲𝘀 𝗰𝗼𝘂𝗹𝗱 𝘀𝘁𝗮𝗿𝘁 as early as 𝗤𝟰/𝟮𝟬𝟮𝟱. 🚀 Impact on the Industry: Adoption promises 𝗿𝗲𝗹𝗶𝗲𝗳 𝗳𝗼𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀, 𝗳𝗮𝗰𝗶𝗹𝗶𝘁𝗮𝘁𝗶𝗻𝗴 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 to new regulations. 📘 Official Release: Upon adoption, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝗹𝗹 𝗰𝗼𝗺𝗲 𝗶𝗻𝘁𝗼 𝗲𝗳𝗳𝗲𝗰𝘁 𝗼𝗻 𝘁𝗵𝗲 𝘀𝗮𝗺𝗲 𝗱𝗮𝘆 upon publication in Official Journal of the #EU. 📻 Stay tuned as we continue to monitor this development closely and provide you with further #insights. 📧 For any 𝗮𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝗰𝗲 or questions regarding these changes, please feel free to reach out to us at: medtech@asphalion.com Read the complete new: https://bit.ly/4dga69G https://bit.ly/3UgU9Y7 #MedTechExperts #EuropeanUnion #MD #IVDs #MedicalDevice #MedicalDevices #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience

Regulatory agencies mandating hemocompatibility tests for medical devices underscore the importance of strategies to minimize complement activation and mitigate its adverse effects. Learn more about how TCC biomarker plays a critical role in assessing safety of medical devices. https://hubs.ly/Q02Kyfqp0 #TCC #MedicalDevices #biocompatibility #hemocompatibility #Complementassessment #ComplementingLifeScience #Immunoassays #Biomarkers #Complementbiology #ISOstandard #ISO10993

Regulatory News: #EUDAMED - roadmap #EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations. The use of EUDAMED is not yet mandatory nor required. Some modules are already available and can be used voluntarily. In particular: > The module on Actor registration is available since December 2020 > The module on UDI/device registration is available since October 2021 > The module on Notified Bodies and Certificates is available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. The remaining modules (Vigilance, Clinical Investigation & Performance Studies and Market Surveillance) are under development and will be released when they are declared functional and become mandatory to use. #References https://lnkd.in/dGB4Avnv https://lnkd.in/dCaRacS4 https://lnkd.in/dKUPjnBC #EUDAMED #Database #EURegulation #MedicalDevices

US FDA News!! (Generative AI-Enabled Devices) The FDA Digital Health Advisory Committee (DHAC) has published an executive summary on "Total Product Lifecycle Considerations for Generative AI-Enabled Devices" On November 20-21, 2024, the Digital Health Advisory Committee will discuss total product lifecycle considerations for generative AI-enabled medical devices. Link to event details: https://lnkd.in/e_egSnnD For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #ivd #medtech #euivdr #eumdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #udi #fda #genai #tplc

The FDA’s medical product Centers have joined forces to release a groundbreaking paper on Artificial Intelligence and Medical Products. This collaborative effort aims to foster transparency, encourage ethical innovation, and safeguard public health. Let’s dive into the details: 📝 Document Highlights: Entities Involved: The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) are all working in harmony. Shared Goal: Their mission? To ensure that medical products benefit society while adhering to responsible regulation. Clear Framework: By providing a clear framework for collaboration, the FDA demonstrates its commitment to advancing medical technology. 🚀 Key Takeaways: Transparency: The joint paper promotes transparency, allowing stakeholders to understand the intersection of AI and medical products. Ethical Innovation: Innovation is essential, but it must be ethical. The FDA’s commitment ensures that cutting-edge solutions prioritize patient safety. Public Health: With this collaboration, public health remains at the forefront, ensuring that advancements benefit everyone. 👏 Let’s applaud this remarkable initiative! Share your thoughts below. 👇 #ArtificialIntelligence #MedicalProducts #PublicHealth #Innovation #FDA #CBER #CDER #CDRH #OCP #QBDgroup #Medtech