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In a world where medical devices are transforming healthcare and saving lives daily, ensuring regulatory compliance is crucial to keep these innovations accessible to those who need them most! A bit late in sharing this, but I’m thrilled to share that I had the amazing opportunity to lead a project at BioElectronics Corporation focused on the development of a Standard Operating Procedure (SOP) for Unique Device Identification (UDI), a critical piece in transitioning our Class IIa medical devices from MDD (Medical Devices Directive) to MDR (Medical Devices Regulation) in the EU. This transition marks a critical shift in EU regulations, with MDR introducing more stringent requirements for medical devices to enhance transparency, traceability, and patient safety. While our devices currently hold "legacy device" status under MDD until 2028, the UDI SOP ensures we are prepared for future MDR certification, ensuring that our life-enhancing products continue to reach patients worldwide post-2028. Project Highlights: •Developed a robust UDI framework, covering key components like UDI-DI, UDI-PI, and EUDAMED integration. •Aligned with MDR requirements, ensuring our QMS and technical documents are future-ready for Notified Body review •Set the company on a path for uninterrupted market access beyond 2028, safeguarding patient care globally. It’s been an incredible experience to contribute to something so impactful and essential for the future of healthcare. I’m looking forward to more opportunities where innovation meets compliance! Also, I would like to thank Zoya Atiq for her immense support and guidance. #MedicalDevices #UDI #MDRCompliance #HealthcareInnovation #SOPDevelopment #PatientSafety #EUDAMED #MilestoneAchieved #RegulatoryAffairs

🚀 Navigating the Future of Medical Devices: UDI Compliance The journey through the regulatory landscape in the medical device industry is crucial for ensuring patient safety and market compliance. As we approach the MDR (Medical Device Regulation) deadline of May 26, 2027, it’s vital for all medical device manufacturers to grasp the importance of UDI (Unique Device Identification) requirements. 🔍 What’s Changing? Under the MDD (Medical Device Directive), UDI wasn’t mandatory. But with the MDR, it’s now a cornerstone for traceability and transparency. The UDI system involves: - Device Identifier (DI): A unique code specific to a device model. - Production Identifier (PI): Codes that include the device’s lot or batch number, serial number, manufacturing date, and expiration date. 💡 Why It Matters: This transition period is a critical time for manufacturers to: 1. Register with an accredited UDI issuing agency. 2. Assign UDIs to each device and update labels accordingly. 3. Integrate UDI information into regulatory documentation and databases. 🌐 The Big Picture: Preparing for UDI implementation is not just about meeting regulatory demands—it’s about enhancing the quality and safety of medical devices globally. Let’s use this time wisely to build a stronger, more reliable healthcare system. 💪 📢 Let’s Discuss: How is your organization approaching UDI compliance? What challenges and strategies are you seeing in the transition from MDD to MDR? Share your experiences and insights below! ⬇️ #MedicalDevices #MDR #UDI #RegulatoryCompliance #PatientSafety #HealthcareInnovation #MedicalDeviceIndustry #Traceability #HealthcareRegulations

Navigating the FDA registration is crucial for anyone involved with medical devices, distinguishing between who’s creating them and who’s handling them. It’s a regulatory framework designed not just to keep tabs but to ensure each player adheres to safety and quality standards. Here’s a streamlined look at the essentials of the process, including key updates for 2024. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝗙𝗗𝗔 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻?  FDA registration differs from FDA approval, which evaluates the safety and efficacy of specific medical devices before they can be marketed. While approval focuses on individual products, registration provides the FDA with detailed information about establishments that manufacture, assemble, or process medical devices. This ensures that all sites comply with regulatory standards and enables effective oversight of the medical device industry. 𝗪𝗵𝗼 𝗡𝗲𝗲𝗱𝘀 𝘁𝗼 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿? Any establishment—defined as a place of business under one management at one general physical location—involved in the manufacturing, assembly, or processing of medical devices intended for U.S. use must register. This includes both domestic manufacturers and foreign entities that export devices to the U.S., with no exemptions based on size or type. 𝗞𝗲𝘆 𝗦𝘁𝗲𝗽𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀:  ⏺ 𝗣𝗮𝘆 𝘁𝗵𝗲 𝗙𝗲𝗲: For FY 2024, the registration fee is $7,653, payable via the Device Facility User Fee website. ⏺ 𝗘𝗹𝗲𝗰𝘁𝗿𝗼𝗻𝗶𝗰 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻: All registration and listing must be submitted electronically through the FDA’s Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM). ⏺ 𝗔𝗻𝗻𝘂𝗮𝗹 𝗨𝗽𝗱𝗮𝘁𝗲: Ensure your registration is updated annually to reflect any changes in device listings or manufacturing activities. 𝗖𝗼𝗺𝗺𝗼𝗻 𝗠𝗶𝘀𝘁𝗮𝗸𝗲𝘀 𝗮𝗻𝗱 𝗧𝗵𝗲𝗶𝗿 𝗜𝗺𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀:  ⏺ 𝗠𝗶𝘀𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Accurate classification is essential to avoid regulatory issues. ⏺ 𝗠𝗶𝘀𝘀𝗶𝗻𝗴 𝗗𝗲𝗮𝗱𝗹𝗶𝗻𝗲𝘀: Delays can lead to a halt in your ability to market and distribute products. 💡 Resources and Support: The FDA provides tools and guidance to help establishments navigate the process: https://lnkd.in/gDi2PFj2 𝗪𝗵𝘆 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿? Registration equips the FDA with necessary oversight capabilities, enhancing public health safety by ensuring that medical device manufacturers meet stringent regulatory standards. Plus, it's mandatory. #FDARegistration #MedicalDeviceSafety #RegulatoryAffairs #HealthcareIndustry

🌐 THE WORLD OF LABELLING ‼ WHAT TO DO IF YOUR MEDICAL DEVICE CANNOT BE LABELLED AS REQUIRED IN ANNEX I MDR ❓Annex I MDR is similar to Annex I of MDD. Previously the abbreviation ER (essential requirements) was used, now the abbreviation GSPR (general safety and performance requirements) is used. The abbreviation is often utilised for referring to a specific requirement of Annex I MDR, regarding different areas of device safety and performance. For example, GSPR23 refers to the twenty-third section of Annex I MDR “Label and instruction for use” which is the topic of this post.   🔑 Justification is the key when it comes to labelling! Many manufacturers fail to recognise that sub-point (b) of GSPR23.1, the information required on the label, must also appear on the device itself. Let’s take the example of medical device that is a fluid, primarily packed in glass vial and then also packed in a paper box. The information must be on the packaging, at each level of packaging (e.g. on the primary packaging, which is the glass vial, and on the secondary packaging, which is the paper box). In such a case, the manufacturer must provide justification in his documentation as to why it is not practicable or appropriate in the particular case to put all mandatory information directly on the product. In the case of a small vial or tube with insufficient space for all the information, only some of the information, i.e. the most important information, may be put on the vial or tube justified with the impracticability. The secondary packaging would then carry all the information required in GSPR23.2.   Want to know more? Don't hesitate and buy full access to our "Practical Guide to the EU Medical Devices Regulation" e-book today. https://lnkd.in/d_Cq4UB4   #medicaldevices #medicaldevice #biotech #FDA #medtech

Regulatory scrutiny of medical devices is increasing across developed economies to keep patients safe and maintain public confidence. Schlafender Hase's Peter Muller and Mike Baird take a look at how well resourced medical device manufacturers and suppliers are to keep pace with the changes and checks needed, here in Medical Product Outsourcing https://lnkd.in/e9hbhADV #medicaldevice #regulations #identification #traceability

Update! Curious about how the FDA's Draft Guidance on PCCPs could impact your medical device updates? Discover how predetermined change control plans can streamline modifications without resubmitting through the regulatory process. Explore the details and ensure compliance with expert guidance! https://lnkd.in/dST5MTyu Mail ID: enquiry@operonstrategist.com    Phone no: +91 9370283428   .   .   .   #FDA #MedicalDevices #PCCP #RegulatoryCompliance #510k #DeviceModifications #MedicalDeviceRegulations #HealthcareInnovation #FDAApproval #healthcareinnovations #government #medicalequipment #operonstrategist #consultation  

Comparing U.S. vs. E.U. Medical Device Regulations When bringing medical devices to market, understanding the regulatory differences between the U.S. and E.U. is critical. Both regions have rigorous frameworks, but their approaches differ in key areas: In the U.S. The FDA oversees medical device regulation. Devices are classified into three classes (I, II, III) based on risk. Higher-risk devices (Class III) require Premarket Approval (PMA), involving extensive clinical trials and review. The U.S. process is focused on proving both safety and effectiveness before devices can be marketed. In the E.U. The E.U. follows the Medical Device Regulation (MDR), which places devices into four risk classes. Devices must obtain a CE marking, demonstrating they meet essential safety requirements. The E.U. focuses more on safety and performance and often allows faster market access with a lower regulatory burden compared to the U.S. However, the introduction of the MDR has significantly tightened oversight, especially for higher-risk devices. Key Differences: The FDA emphasizes premarket approval for high-risk devices, while the E.U. offers faster access via the CE marking process. In the U.S., clinical trials are required for Class III devices, while in the E.U., clinical evaluation is mandatory under MDR but may not always require trials for all devices. Post-market surveillance is increasingly stringent in both regions, with the E.U. adopting more rigorous oversight through the MDR. #HealthcareInnovation #MedicalDevices #FDA #MDR #RegulatoryCompliance

Update! Curious about how the FDA's Draft Guidance on PCCPs could impact your medical device updates? Discover how predetermined change control plans can streamline modifications without resubmitting through the regulatory process. Explore the details and ensure compliance with expert guidance! https://lnkd.in/ecnW47iE Mail ID: enquiry@operonstrategist.com    Phone no: +91 9370283428   .   .   .   #FDA #MedicalDevices #PCCP #RegulatoryCompliance #510k #DeviceModifications #MedicalDeviceRegulations #HealthcareInnovation #FDAApproval #healthcareinnovations #government #medicalequipment #operonstrategist #consultation  

Hi friends!!! Check out for this blog EU MDR Certificates issued by Notified Body In this blog you can gain knowledge about EU MDR Annex XII & its requirements Please do follow this blog page to get regular updates about topics related to Biomedical Engineering, Medical Devices, Healthcare. #biomedicalengineering #eumdr #qualityengineering #regulatoryaffairs #medicaldevices

Regulatory scrutiny of medical devices is increasing across developed economies to keep patients safe and maintain public confidence. Schlafender Hase's Peter Muller and Mike Baird take a look at how well resourced medical device manufacturers and suppliers are to keep pace with the changes and checks needed, here in Medical Product Outsourcing https://lnkd.in/e9hbhADV #medicaldevice #regulations #identification #traceability