Veritas Innovation ’s Post

📢 𝗘𝘅𝗰𝗶𝘁𝗶𝗻𝗴 𝗡𝗲𝘄𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗙𝗗𝗔! The US FDA has just released the updated version of the ‘𝘎𝘭𝘰𝘣𝘢𝘭 𝘜𝘯𝘪𝘲𝘶𝘦 𝘋𝘦𝘷𝘪𝘤𝘦 𝘐𝘥𝘦𝘯𝘵𝘪𝘧𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘋𝘢𝘵𝘢𝘣𝘢𝘴𝘦 (𝘎𝘜𝘋𝘐𝘋)’ guidance! This marks a significant step in ensuring compliance with UDI regulations and enhancing submission processes. ✨ 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀: ❌ Removal of references to FDA Preferred Term Codes (PT), as access to GMDN Terms is now free. ✅ Mandatory use of GMDN codes for device identification. 🔧 Enhanced validation rules and improved user interface for better data quality and workflow optimization. These updates reinforce the importance of accurate and efficient medical device identification, which is critical for both compliance and patient safety. As someone passionate about regulatory affairs and compliance, I see these changes as a great opportunity for medical device companies to streamline their processes and stay ahead in the ever-evolving regulatory landscape. 💡 Smart MDR is here to help companies navigate these updates and turn compliance into a competitive advantage. If you’d like to learn more, feel free to reach out! 🌐 Visit: www.smartmdr.com 📩 Contact: commercial@4easyprrc.com Let’s shape the future of medical device compliance together! Sandra Balseiro Luiz de Pádua Queiroz Júnior Celeste Oliveira Natalia de Souza Lescura 4 Easy PRRC #FDA #GUDID #UDI #RegulatoryAffairs #Compliance #MedicalDevices #SmartMDR #4EasyPRRC

📢 𝗡𝗲𝘄 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗣𝗖𝗖𝗣𝘀: 𝗗𝗿𝗶𝘃𝗶𝗻𝗴 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀! 🌐 The FDA has just released a new guidance on Predetermined Change Control Plans (PCCPs) for medical devices. This guidance provides a framework for manufacturers to implement modifications to their devices without the need for new marketing submissions. ✅ 𝗠𝗮𝗶𝗻 𝗯𝗲𝗻𝗲𝗳𝗶𝘁𝘀: 🔹 𝗙𝗹𝗲𝘅𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Innovate and improve your devices without compromising safety. 🔹 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆: Reduce the regulatory burden and speed up the implementation of changes. 🔹 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Ensure that changes are in line with FDA expectations. ❓ 𝗪𝗮𝗻𝘁 𝘁𝗼 𝗸𝗻𝗼𝘄 𝗺𝗼𝗿𝗲 𝗮𝗯𝗼𝘂𝘁 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗣𝗖𝗖𝗣𝘀 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗮𝗻𝘆? 🤝 Contact us and find out how to comply with FDA requirements: https://lnkd.in/dtEghM3g #PCCPs #MedicalDevices #FDA #Regulation #Innovation #Health #MedicalTechnology Sandra Balseiro Ana Brito Viviana Gomes Celeste Oliveira Natalia de Souza Lescura

🔍 Understanding the Difference: Certification Body vs. Notified Body 🔍 In the world of regulatory compliance, it's crucial to distinguish between a Certification Body and a Notified Body. While both play essential roles, their functions and responsibilities differ significantly: 📜 Certification Body: -  Certification Bodies are independent organizations that assess and certify the conformity of products, processes, and systems to specific standards. Usually, certification bodies are accredited according to ISO 17024, ISO 17025 or similar standards. - They certify compliance with national and international standards such as ISO 9001, ISO 13485, and many others. - Their services are often used for voluntary certification, ensuring quality and consistency in various sectors.   🏅 Notified Body: - Notified Bodies are organizations designated by EU or EEA member states to assess the conformity of products with the requirements of specific European Directives and Regulations. Usually, a notified body is also a certification body. - Their assessment is mandatory for certain categories of products before they can be marketed in the European Economic Area (EEA). - Specifically for medical devices, they are heavily involved in the evaluation of higher risk products against the Medical Device Regulation (MDR classes I* to III ) and In Vitro Diagnostic Regulation (IVDR classes As to D).   In summary: while both Certification Bodies and Notified Bodies assess and certify conformity, Notified Bodies have a regulatory mandate to ensure products meet EU directives and regulations, particularly in the medical device sector. Certification Bodies, on the other hand, provide a broader range of certification services across various industries, often on a voluntary basis.   Understanding these differences is key for navigating regulatory landscapes and ensuring their products meet the necessary standards and regulations.   Feel free to share your experiences or ask questions in the comments below! 🚀   #MedicalDevices #Certification #NotifiedBody #MDR #IVDR 

🚨 New Q&A Document🚨 Practical guidance on the new obligations under Regulation (EU) 2024/1860, amending the MDR and IVDR. 📌 Key Takeaways: 🔹 Notification requirement: Manufacturers must inform competent authorities and health institutions before disrupting or discontinuing the supply of certain medical devices or IVDs. 🔹 Supply Chain Communication: If manufacturers do not supply directly to health institutions, they must notify the relevant economic operators (manufacturer, authorized representative, importer, distributors, and system and procedure pack producer (only for MDR) who, in turn, must inform health institutions. The aim is to allow health authorities and institutions to consider mitigating actions to minimize any potential risks to patient health and safety due to supply disruptions. This ensures a proactive approach to managing potential impacts on patient care and safety. The Q&A document also touches on the gradual implementation of the Eudamed database as part of the regulation’s broader framework, and specific transitional provisions are outlined for certain in vitro diagnostics (IVDs). Are you interested in getting further details on this topic? The link to the original Q&A document can be found in the comments below 👇 #MedicalDevices #IVDs #RegulatoryAffairs #MedTech #compliance

Navigating Medical Device Regulations: A Strategic Approach The medical device industry is rapidly evolving, driven by innovation and a growing demand for healthcare solutions. However, with great innovation comes the responsibility to ensure safety, efficacy, and compliance with regulatory standards. Navigating the complex landscape of medical device regulations requires a strategic approach. Key considerations include: Understanding Global Regulatory Frameworks: Each market has unique requirements, from the FDA in the USA to CE marking in Europe and ROW-specific standards. Tailoring submissions to meet these diverse expectations is crucial. Product Classification and Risk Assessment: Correct classification based on intended use and risk level determines the regulatory pathway. A thorough risk assessment ensures compliance and patient safety. Clinical Data and Technical Documentation: Comprehensive technical files and clinical evaluations are the backbone of regulatory submissions. Aligning with standards like ISO 13485 enhances acceptance. Post-Market Surveillance: Compliance doesn't end at market entry. Vigilant post-market monitoring and prompt reporting of adverse events safeguard both patients and company reputation. At Acumen, we specialize in simplifying the regulatory journey for medical devices. Our expertise in technical documentation and regulatory strategy ensures smooth market access, allowing innovators to focus on what they do best—transforming healthcare. Let’s connect to discuss how we can streamline your regulatory processes and support your global compliance goals. #MedicalDevices #RegulatoryAffairs #Compliance #HealthcareInnovation #MarketAccess

Navigating the complexities of FDA registration and listing can be daunting, especially for companies new to the medical products industry. Ensuring compliance is critical, but the process often raises more questions than answers. Our latest blog, "Navigating Registration and Listing for FDA Regulated Products," breaks down this essential step in bringing your product to market. We cover everything from understanding FDA requirements to avoiding common pitfalls and ensuring a smooth path to compliance. At RQMIS, we know that a solid regulatory foundation is key to your success. Whether you're a startup or an established company, our insights and expertise can help you confidently navigate the FDA's regulatory landscape. Check out the full blog here https://lnkd.in/eXHT-6qk and let us guide you through this critical aspect of getting your medical products to market! #FDACompliance #MedicalDevices #RegulatoryAffairs #QualityManagement #RQMIS

🔴 𝐂𝐫𝐨𝐬𝐬-𝐫𝐞𝐟𝐞𝐫𝐞𝐧𝐜𝐞𝐬 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬 𝐢𝐧 𝐀𝐧𝐧𝐞𝐱 𝐗𝐕 𝐜𝐡𝐚𝐩𝐭𝐞𝐫 𝐈𝐈 𝐨𝐟 𝐭𝐡𝐞 𝐌𝐃𝐑 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐢𝐨𝐧 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐏𝐚𝐜𝐤𝐚𝐠𝐞 🔴 Are you preparing for a clinical investigation under the EU MDR? Ensuring compliance is crucial. We’ve introduced an essential tool: Cross-references between requirements in Annex XV Chapter II of the MDR and the Clinical Investigation Submission Package. Before submitting your Investigator’s Brochure (IB), use this checklist to ensure it meets the minimum requirements for validation as per Article 70 of the MDR. 🔗 Stay compliant and streamline your submission process! ➡ https://lnkd.in/d6K8Sdw9 #MedicalDevices #EUMDR #ClinicalInvestigations #RegulatoryCompliance #MedicalDeviceRegulation #MDR #NotifiedBodies #Healthcare #MedTech #ClinicalResearch #Innovation #RegulatoryAffairs #CECertification

📢 𝗙𝗗𝗔 𝗥𝗲𝗹𝗲𝗮𝘀𝗲𝘀 𝗙𝗶𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗥𝗲𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 🛠 In a pivotal move, the FDA has published its final guidance on the remanufacturing of medical devices, a document that 𝗰𝗹𝗮𝗿𝗶𝗳𝗶𝗲𝘀 𝘁𝗵𝗲 𝗱𝗶𝘀𝘁𝗶𝗻𝗰𝘁𝗶𝗼𝗻 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝘀𝗲𝗿𝘃𝗶𝗰𝗶𝗻𝗴 𝗮𝗻𝗱 𝗿𝗲𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴. This guidance is critical for ensuring that medical devices remain safe and effective for patient use. 👉 𝗪𝗵𝗮𝘁'𝘀 𝗡𝗲𝘄? The guidance aims to help industry stakeholders understand the nuances of what constitutes remanufacturing versus mere servicing, which includes routine maintenance. A key addition is a section on regulatory requirements, emphasizing that remanufacturers will now face similar investigations and inspections as manufacturers, ensuring higher standards of safety and performance. ❓ 𝗪𝗵𝘆 𝗗𝗼𝗲𝘀 𝗧𝗵𝗶𝘀 𝗠𝗮𝘁𝘁𝗲𝗿? This update is crucial not just for compliance but for patient safety. Ensuring that remanufactured devices meet stringent standards helps prevent malfunctions and guarantees that medical devices function as intended. 💬 Share your insights! What are your thoughts on this new regulatory guidance? 𝗗𝗼 𝘆𝗼𝘂 𝘀𝗲𝗲 𝘁𝗵𝗶𝘀 𝗮𝗳𝗳𝗲𝗰𝘁𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝘀𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝘁𝗵𝗲 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆? 🔗 For more detailed information on this guidance, check out the full story here: https://lnkd.in/dD7wjKbR #MedicalDevices #FDA #HealthcareInnovation #PatientSafety #Guidance #MDSS #USAgent #News #MedicalDevices

FDA issues final guidance on "Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers" Read Full Guidance: https://lnkd.in/gcJzT8nX

 #BreakingNews The FDA has posted the unpublished final rule for #LDT Regulation. Formal publication is scheduled for the 6th of May. Full-text: https://lnkd.in/g6tRkaSi Take-away messages from a first, top-level reading: 📌𝐆𝐫𝐚𝐧𝐝𝐟𝐚𝐭𝐡𝐞𝐫𝐢𝐧𝐠 𝐂𝐥𝐚𝐮𝐬𝐞: FDA intends to exercise enforcement discretion and generally not enforce premarket review and #qualitysystem requirements (except for requirements under part 820, subpart M (Records)) 𝐟𝐨𝐫 𝐜𝐮𝐫𝐫𝐞𝐧𝐭𝐥𝐲 𝐦𝐚𝐫𝐤𝐞𝐭𝐞𝐝 𝐈𝐕𝐃𝐬 𝐨𝐟𝐟𝐞𝐫𝐞𝐝 𝐚𝐬 𝐋𝐃𝐓𝐬 𝐭𝐡𝐚𝐭 𝐰𝐞𝐫𝐞 𝐟𝐢𝐫𝐬𝐭 𝐦𝐚𝐫𝐤𝐞𝐭𝐞𝐝 𝐩𝐫𝐢𝐨𝐫 𝐭𝐨 𝐭𝐡𝐞 𝐝𝐚𝐭𝐞 𝐨𝐟 𝐢𝐬𝐬𝐮𝐚𝐧𝐜𝐞 𝐨𝐟 𝐭𝐡𝐢𝐬 𝐫𝐮𝐥𝐞. Yet, as a counterbalance, the FDA will be at liberty to determine whether LDTs on market have adequate validation and performance, via 21 CFR 807.26(e). 📌 𝐍𝐘𝐒 𝐂𝐋𝐄𝐏 𝐏𝐫𝐨𝐯𝐢𝐬𝐢𝐨𝐧: FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements for LDTs approved by NYS CLEP (tests validated by the New York State Clinical Laboratory Evaluation Program). 📌 Integrated Laboratories: FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements and QS requirements (except for requirements under part 820, subpart M (Records)) 𝐟𝐨𝐫 𝐋𝐃𝐓𝐬 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐝 𝐚𝐧𝐝 𝐩𝐞𝐫𝐟𝐨𝐫𝐦𝐞𝐝 𝐛𝐲 𝐚 𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐨𝐫𝐲 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐞𝐝 𝐰𝐢𝐭𝐡𝐢𝐧 𝐚 #𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞𝐬𝐲𝐬𝐭𝐞𝐦 𝐭𝐨 𝐦𝐞𝐞𝐭 𝐚𝐧 𝐮𝐧𝐦𝐞𝐭 𝐧𝐞𝐞𝐝 𝐨𝐟 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬 𝐫𝐞𝐜𝐞𝐢𝐯𝐢𝐧𝐠 𝐜𝐚𝐫𝐞 𝐰𝐢𝐭𝐡𝐢𝐧 𝐭𝐡𝐞 𝐬𝐚𝐦𝐞 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐬𝐲𝐬𝐭𝐞𝐦 - There is huge room for interpretation in this provision. Stay tuned for a full-impact analysis. #medtech #biotech #invitrodiagnostics #Laboratorydevelopedtests #diagnostics #fdacompliance