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Understanding the key terms in the regulation of medical devices is essential for medical device manufacturers. 🏛️ REGULATIONS are legally binding rules set by governmental bodies. They ensure medical devices are safe and effective. For example, the FDA's 21 CFR Part 820 in the USA, the CDSCO’s Medical Devices Rules, 2017in India and the European Union's MDR 2017/745 mandate specific requirements for device manufacturers. Non-compliance can lead to severe penalties, including product recalls. 📏 STANDARDS are consensus-based guidelines developed by organizations like ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission). They provide technical specifications and criteria to ensure products, processes, and services are safe and reliable. An example is ISO 13485, which specifies requirements for a quality management system in the design and manufacture of medical devices. Following these standards can streamline compliance with regulations. 📚 GUIDANCE DOCUMENTS offer regulatory agencies' current thinking on a topic. They are not legally binding but provide clarity on regulatory expectations. For example, the FDA's guidance on "Human Factors and Medical Devices" helps manufacturers understand how to design devices for safe and effective use. These documents simplify the compliance process. 📝 CODES are systematic collections of laws or regulations. In the context of medical devices, they can refer to coding systems like the Global Medical Device Nomenclature (GMDN), which provides a standardized way to name and categorize medical devices. Each of these elements plays a critical role in the lifecycle of a medical device, from concept to market. Understanding and adhering to them is vital for successful product development and patient safety. Follow for daily insights into tech product development. #MedicalDevices #Compliance #QualityAssurance #SimplifyingInnovation #Unplex

🚀 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

Decoding UDI-DI In the ever-evolving landscape of medical device regulation, the Unique Device Identification - Device Identifier (UDI-DI) stands out as a pivotal element in enhancing device traceability, patient safety, and regulatory compliance. But what exactly is UDI-DI, and why is it so crucial? What is UDI-DI? The Unique Device Identification - Device Identifier (UDI-DI) is a mandatory component of the Unique Device Identification (UDI) system established by regulatory authorities like the FDA and the EU MDR. The UDI-DI serves as the static portion of the UDI and uniquely identifies the specific version or model of a device. Key Components of UDI-DI: 1. Static Identifier: Unlike the UDI-PI (Production Identifier), which can change with each production run, the UDI-DI remains consistent for a particular device model/version. 2. Device Identification: It includes information such as the manufacturer’s name, the device’s make and model, and other essential details that uniquely identify the device. 3. Database Entry: The UDI-DI is entered into a centralized database, such as the FDA’s Global Unique Device Identification Database (GUDID) or the European Database on Medical Devices (EUDAMED). Why is UDI-DI Important? • Enhanced Traceability: Facilitates precise tracking of medical devices throughout their lifecycle, from manufacturing to distribution to patient use. • Improved Safety: Enables rapid identification and recall of devices in case of adverse events or malfunctions, thus protecting patient health. • Regulatory Compliance: Meets stringent regulatory requirements, ensuring market access and maintaining the manufacturer’s reputation. • Data Integration: Enhances interoperability and data integration across healthcare systems, improving clinical workflows and patient care. How to Implement UDI-DI: 1. Assign UDI-DI: Use an accredited issuing agency to assign a unique UDI-DI to each device model/version. 2. Labeling: Ensure the UDI-DI is clearly marked on the device label and, where applicable, on the device itself. 3. Database Submission: Submit the UDI-DI and associated device information to the relevant regulatory database (e.g., GUDID, EUDAMED). 4. Maintain Records: Keep accurate and up-to-date records of all UDI-DIs and their corresponding devices. #MedicalDevices #UDI #Traceability #PatientSafety #RegulatoryCompliance #HealthcareInnovation #EUMDR #FDA #QualityManagement #DeviceIdentifier

Swissmedic update for manufacturers/developers of medical device software and for economic operators! Software is gaining importance in medicine and healthcare industry. This greater importance is underscored not only by a rising number of software application options for medical purposes but also in the corresponding regulations. In fact, software is explicitly included in the definition of medical devices in the Medical Devices Ordinance (MedDO SR 812.213) and in the definition in the Ordinance on In Vitro Diagnostic Medical Devices (IvDO SR 812.219). Medical devices under MedDO or IvDO are subject to strict requirements as regards product safety and the quality management of the organisations involved in their development, manufacture, distribution, sale and maintenance. If software is qualified as a device according to the relevant provisions of MedDO or IvDO, a number of regulations and standards must be observed and taken into account. Guidelines such as the MDCG documents also provide recommendations for implementing the European regulations. Link: https://lnkd.in/e3VbQ7ig Medical Device Software.pdf #medicaldevices #invitrodiagnostics #qualityassurance #regulatoryaffairs

Quality testing in the medical devices industry is crucial for several reasons: 1. Patient safety: Medical devices are used to diagnose, monitor, and treat patients, so it is essential that they are safe and effective. Quality testing helps ensure that devices meet regulatory standards and do not pose any risks to patients. 2. Regulatory compliance: The #medical devices industry is highly regulated The importance of quality testing in Medical devices industry, with strict guidelines set by organizations such as the FDA and ISO. Quality testing helps manufacturers demonstrate compliance with these regulations and obtain necessary approvals for their products. 3. Reliability and performance: Medical devices need to perform consistently and accurately in order to provide reliable results for healthcare professionals and patients. #Quality testing helps identify any defects or issues that could affect the device's performance. 4. Reputation: A reputation for producing high-quality, reliable medical devices is essential for #manufacturers to succeed in the industry. Quality testing helps ensure that products meet customer expectations and maintain a positive reputation in the market. 5. Cost savings: Identifying and addressing quality issues early in the #development process can help manufacturers avoid costly recalls, repairs, or legal liabilities down the line. Investing in quality testing upfront can ultimately save companies time and money in the long run. Overall, quality #testing plays a critical role in ensuring the safety, effectiveness, and reliability of medical devices, ultimately benefiting both patients and manufacturers in the industry.

#Medicaldevice labeling plays a crucial role in ensuring #patientsafety and #regulatorycompliance. From providing clear usage instructions to conveying essential warnings and contraindications, effective labeling is paramount in the healthcare industry. Many regulatory bodies require medical devices to have unique identifiers for traceability and post-market surveillance purposes. Implementing and managing #UDI systems on labels can be complex, especially for manufacturers with large product portfolios. At Techsol, we help #MedTech companies to overcome complexities involved in medical device labeling with our global regulatory expertise, fulfilling multilingual #labelling requirements, and user-centered #package and #label design. By leveraging our solutions, manufacturers can navigate the intricate landscape of medical device labeling with confidence, ensuring that their products meet global standards while prioritizing patient safety. To request a free consultation, please visit https://lnkd.in/ghU8pBUu

The EUDAMED user guide Legacy Devices provides comprehensive instructions on the identification and registration process for legacy devices in the European Databank on Medical Devices (EUDAMED). 📌 The guide comprises several sections, including an introduction, identification details, registering legacy devices, management of regulation and legacy devices, linking regulation devices to legacy devices, and an annex on legacy device certificate types. 📍 It emphasizes the importance of maintaining a standard structure and identification elements for all devices registered in EUDAMED, including the generation of EUDAMED DI and EUDAMED ID for legacy devices, based on whether a UDI-DI already exists or not. The registration process involves multiple steps, such as providing EUDAMED DI identification information, certificate information, device identification information, device characteristics, and device information. 🔗 Furthermore, the document highlights the significance of managing regulation and legacy devices, as well as the ability to link regulation devices with corresponding legacy devices automatically when they share the same UDI-DI. Additionally, it points to the availability of specific chapters in the dedicated UDI Devices user guide for further information on managing regulation and legacy devices, as well as linking registered devices. The annex provides a detailed list of certificate types applicable to legacy devices, depending on the relevant legislation. 🔄 Overall, the user guide serves as a comprehensive resource for manufacturers and stakeholders involved in the identification, registration, and management of legacy devices within the EUDAMED platform. In summary, the EUDAMED user guide Legacy Devices offers a systematic and detailed overview of the processes involved in identifying, registering, and managing legacy devices within the EUDAMED system. It provides insights into the generation of identification details for legacy devices, the step-by-step registration process, and the linkage between regulation and legacy devices. ⏩ The document's structured approach and detailed explanations make it a valuable resource for understanding and navigating the complexities of legacy device registration and management within the EUDAMED platform, catering to the needs of manufacturers and other relevant stakeholders in the medical device industry. #EUDAMED #MedicalDeviceRegulation #LegacyDevices #Compliance #RegulatoryAffairs

The Rising Challenges of Packaging and Labeling in the Medical Device Industry. As global regulations around tracking and supply chain transparency become more stringent, the task of producing compliant packaging and labeling for medical devices has never been more challenging. A 2024 study commissioned by Schlafender Hase surveyed 202 regulatory professionals at Class 2 and 3 medical device companies in Germany and the US to explore these challenges. The findings are striking: ◾Translations are a major hurdle, with 65% of respondents finding them challenging to manage. ◾Barcodes pose difficulties for 61% of respondents, highlighting the complexities of ensuring accuracy and compliance. ◾Graphics, including symbols (e.g., device sterilization icons), are tough to handle for 60%. ◾Tables also present significant challenges, cited by 59% of respondents. ◾Even getting the text right remains an issue, with 54% finding this aspect challenging. As the demands on packaging and labeling continue to grow, the need for robust processes and tools to manage these elements effectively is more critical than ever. How is your organization addressing these challenges? Download the report: https://lnkd.in/efrRCfG3 #MedicalDevices #RegulatoryAffairs #Packaging #Labeling

Poka-yoke (error-proofing) systems can significantly help medical device manufacturers in several ways: 1. *Reduced errors*: Poka-yoke systems are designed to prevent mistakes from occurring in the first place, ensuring that medical devices are manufactured with minimal errors. 2. *Improved quality*: By detecting and preventing errors, poka-yoke systems help maintain high-quality standards in medical device manufacturing. 3. *Increased efficiency*: Error-proofing systems streamline the manufacturing process, reducing waste and saving time. 4. *Compliance with regulations*: Poka-yoke systems help medical device manufacturers comply with regulatory requirements and industry standards. 5. *Patient safety*: By ensuring the accuracy and quality of medical devices, poka-yoke systems contribute to patient safety and well-being. 6. *Reduced recalls*: Error-proofing systems help minimize the risk of device recalls, which can be costly and damaging to a company's reputation. 7. *Improved traceability*: Poka-yoke systems can provide traceability of components and devices, making it easier to track and manage inventory. By implementing poka-yoke systems, medical device manufacturers can enhance their overall quality management system, reduce risks, and improve patient outcomes.

Informations supplied with the medical devices, what to do? ↴ Let’s break it down. These are non-negotiables under 2017/745: → Unique Device Identification (UDI) UDI required for all devices (except custom-made). Appears on labels, packaging (not shipping), and reusable devices. Also required in the EU Declaration of Conformity, technical docs, and SSCP. → Labels & Instructions For Use (IFU) Mandatory unless Class I or IIa devices can be safely used without instructions. For others, labeling follows Regulation 2017/745 (Annex I). → Summary of Safety and Clinical Performance (SSCP) For Class III and implantable devices (excluding custom-made). SSCP validated by notified bodies and available on Eudamed. → Implantable devices Info must be layperson-friendly and in the patient’s language. Updates go online via the manufacturer’s website. Implant cards with device ID details are a must. → Custom-made devices Must include a manufacturer or authorized representative’s statement (Annex XIII, Regulation 2017/745). Need more insight like this? Download our guide to the MDR 2017/745 right here : https://lnkd.in/e5ZeVreC What requirements would you like to see in this format (with a clear reference to MDCG / MDR standards, etc.)?