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  • EU MDR & IVDR Certification: Navigating the Notified Body Capacity Crunch and Timeline Compression

    EU MDR & IVDR Certification: Navigating the Notified Body Capacity Crunch and Timeline Compression
    Jan 29 2026
    This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, significant bottlenecks in audit scheduling and technical documentation review are creating a "timeline compression" risk. We explore why manufacturers must strategically prioritize their product portfolios and engage with Notified Bodies much earlier than planned to avoid jeopardizing market access as deadlines approach. - Why is Notified Body availability still a major risk despite MDR/IVDR deadline extensions? - What is "timeline compression" and how does it affect legacy devices? - How should manufacturers strategically prioritize products for EU certification? - What are the hidden delays in scheduling audits and technical file reviews? - Was the May 26, 2024 application deadline a false finish line? - Are the extended transition periods creating a false sense of security? - What steps can you take now to secure your place in the certification queue? Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, leveraging local expertise and advanced AI to accelerate global market access. We develop efficient regulatory strategies, assist with technical dossier submissions, and act as your local representative in over 30 markets to get your products approved efficiently. Our technology-driven approach streamlines compliance and market research, helping you navigate complex environments like the EU. Whether you are a startup or a multinational, we have scalable solutions to support your expansion. Contact us at info@pureglobal.com, visit https://pureglobal.com/, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • EU MDR & IVDR Simplification: What the 2025 Proposal Means for MedTech

    EU MDR & IVDR Simplification: What the 2025 Proposal Means for MedTech
    Jan 28 2026
    This episode unpacks the European Commission's significant proposal of December 16, 2025, aimed at the targeted simplification of the MDR and IVDR. We explore the potential impacts on documentation, digitalization through EUDAMED, and what these changes could mean for manufacturers, especially SMEs, as they navigate the complex European regulatory landscape. Key Questions: - What specific changes are included in the EU Commission's "targeted simplification" proposal? - How could the proposed MDR/IVDR updates affect documentation and compliance costs? - What role will digitalization and the mandatory use of EUDAMED play in the future? - Are Small and Medium-sized Enterprises (SMEs) specifically addressed in this proposal? - What is the legislative timeline, and when might these changes take effect? - Should manufacturers alter their current regulatory strategy based on this news? - How will the proposal impact market access and device availability in the EU? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI and data tools to streamline global market access. We develop efficient pathways for regulatory approval, using AI to compile and submit technical documents, and act as your local representative in over 30 markets. Whether you're a startup or a multinational enterprise, our technology-driven approach ensures you can navigate complex environments and bring innovations to market faster. Visit us at https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • EU Supply Chain Alert: Navigating Medical Device Shortage Notifications Under Regulation 2024/1860

    EU Supply Chain Alert: Navigating Medical Device Shortage Notifications Under Regulation 2024/1860
    Jan 27 2026
    This episode unpacks the critical amendments introduced by Regulation (EU) 2024/1860, focusing on the new obligations for medical device manufacturers to notify authorities about supply interruptions and discontinuations. We explore why this has become a major compliance challenge, touching on its impact on portfolio management, distributor relations, and the necessity for early risk detection systems to prevent shortages and ensure market stability in the European Union. - What are the new supply shortage notification rules under EU Regulation 2024/1860? - When must a manufacturer inform authorities about discontinuing a medical device? - Why is supply continuity now a major compliance hotspot in the EU? - How does this regulation affect your product portfolio and end-of-life planning? - What systems should you have in place to flag potential supply interruptions early? - How should communication with distributors be managed in light of these new rules? - What are the potential consequences of failing to comply with these notification requirements? Navigating complex regulations like the EU's new supply continuity rules is essential for maintaining market presence. Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, ensuring you stay compliant across more than 30 global markets. Our experts develop clear regulatory strategies and use advanced AI to monitor regulatory changes, helping you anticipate challenges and maintain uninterrupted market access. We act as your local representative, handling communications with authorities so you can focus on your business. For support, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860

    EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860
    Jan 26 2026
    This episode details the crucial extension of the In-Vitro Diagnostic Regulation (IVDR) transition periods under the EU's Regulation 2024/1860. We explore the specific, time-sensitive conditions manufacturers must meet to benefit from this extension, including Quality Management System requirements and mandatory engagement with a Notified Body. This is essential information for any IVD manufacturer looking to maintain market access in the European Union. - What is Regulation (EU) 2024/1860 and how does it affect your IVD products? - Are your legacy devices eligible for the new IVDR transition extension? - What specific conditions must be met to keep your products on the EU market? - By when must you have a compliant Quality Management System in place? - What are the crucial deadlines for applying to and signing an agreement with a Notified Body? - What constitutes a 'significant change' that could void your eligibility? - How can you start preparing your application for a notified body right now? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI. We act as your local representative in over 30 markets, develop efficient regulatory strategies, and use AI to compile technical dossiers. Our team helps you maintain compliance through post-market surveillance and continuous regulatory monitoring, ensuring your products meet international standards. Whether you're a startup or a multinational, we provide tailored solutions for your expansion needs. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • The EUDAMED Clock is Ticking: Understanding the EU's Mandatory 2026 Deadlines

    The EUDAMED Clock is Ticking: Understanding the EU's Mandatory 2026 Deadlines
    Jan 25 2026
    This episode details the crucial update on the EUDAMED gradual roll-out. We explain the impact of the European Commission's Implementing Decision (EU) 2025/2371, which confirms the functionality of the first four EUDAMED modules. The discussion covers which modules are now live, the official start date for mandatory use—May 28, 2026—and what actions medical device and IVD manufacturers must take to ensure compliance for market access in the European Union. Key Questions: - What is Commission Implementing Decision (EU) 2025/2371 and why is it important? - Which four EUDAMED modules are now officially considered functional? - What is the exact date that mandatory use of these EUDAMED modules begins? - How does the gradual roll-out affect registrations for new and legacy medical devices? - What are the immediate actions manufacturers must take to prepare for the 2026 deadline? - Will the Vigilance and Clinical Investigation modules also be mandatory in 2026? - What is a Single Registration Number (SRN) and why is it essential? Struggling with complex regulatory changes like the EUDAMED rollout? Pure Global offers end-to-end consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using advanced AI to compile technical dossiers. Our services cover the entire product lifecycle, from initial market research to post-market surveillance. Let us help you navigate the EU market with confidence. Visit us at https://pureglobal.com/, contact info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
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    3 Min.
  • COFEPRIS Uncovered: Comparing Mexico's Device Classification to FDA and EU Rules

    COFEPRIS Uncovered: Comparing Mexico's Device Classification to FDA and EU Rules
    Jan 24 2026
    This episode provides a detailed overview of Mexico's three-tiered medical device classification system managed by COFEPRIS. We explore how Class I, Class II, and Class III devices are defined by risk and highlight the key differences between Mexico's framework and the systems used by the US FDA and the European Union. Understanding these nuances is the critical first step for successful market entry. - How does Mexico's COFEPRIS classify medical devices? - What are the three risk-based classes for medical devices in Mexico? - Is there a special category for low-risk Class I devices in Mexico? - Can a device's US FDA classification be used for registration in Mexico? - How does Mexico's 3-class system differ from the EU's 4-class model? - Why is it a mistake to assume classifications are the same across regions? - Which regulation governs device classification in Mexico? - What determines the regulatory pathway and cost for market access in Mexico? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI tools. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using AI to compile and submit technical dossiers. Our integrated approach allows a single registration process to access multiple markets, saving you time and resources. To accelerate your global expansion and ensure ongoing compliance, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico

    MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico
    Jan 23 2026
    This episode details the critical error of applying South Korea's four-tier MFDS medical device classification directly to Mexico's three-tier COFEPRIS registration system. We explain why the differing regulatory frameworks, classification rules, and risk criteria make a direct transfer impossible and discuss the severe consequences of such a mistake, including immediate rejection, costly delays, and reputational damage with the regulatory authority. - Why is it a mistake to use a Korean device classification for a Mexican market submission? - What are the primary differences between the MFDS and COFEPRIS classification systems? - How many risk classes for medical devices exist in South Korea versus Mexico? - What are the consequences of submitting a device to COFEPRIS with the wrong classification? - Can a device's risk level change when moving from the Korean to the Mexican market? - How do different national regulations impact global market access strategy? - What is the first step to ensure a smooth registration process in Mexico? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. Our experts develop efficient regulatory strategies, leveraging a single registration process to access over 30 markets, including Mexico and South Korea. We use advanced AI and data tools to compile technical dossiers, manage submissions, and provide continuous regulatory monitoring, ensuring your products meet local standards from initial strategy to post-market surveillance. Let us handle the complexities of COFEPRIS and MFDS regulations. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • Korean Devices in Mexico: Mastering COFEPRIS Classification and Grouping

    Korean Devices in Mexico: Mastering COFEPRIS Classification and Grouping
    Jan 22 2026
    This episode focuses on the critical regulatory hurdles Korean medical device companies face when entering the Mexican market. We delve into the specifics of COFEPRIS's three-tier classification system, highlighting its key differences from Korea's four-class MFDS framework. Listeners will learn why misclassification is a primary cause of submission rejections and how a strategic approach to device grouping can significantly reduce registration costs and timelines, ensuring a smoother and more efficient market entry into Mexico. Key Questions: - How does Mexico's COFEPRIS device classification differ from Korea's MFDS system? - What are the most common reasons for COFEPRIS submission rejections? - Why is a device grouping strategy essential for entering the Mexican market? - How can you minimize costs and delays when registering multiple devices in Mexico? - What international frameworks influence Mexico's medical device regulations? - Are there specific nuances Korean manufacturers must know before submitting to COFEPRIS? Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining your path to international markets. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers for markets like Mexico. We act as your local representative in over 30 countries, ensuring your products achieve and maintain compliance. Whether you are a startup or a multinational, our technology-driven solutions accelerate your global expansion. For a consultation, contact info@pureglobal.com or visit https://pureglobal.com. Explore our free regulatory AI tools and database at https://pureglobal.ai.
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    3 Min.