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  • EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028?

    EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028?
    2025/05/30
    This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. The focus for 2025 shifts from new extension-specific filings to the continuous maintenance of an MDR-compliant Quality Management System, robust post-market surveillance, and up-to-date technical documentation, ensuring devices remain safe and that manufacturers are audit-ready. Key Questions: • What are the new EU MDR compliance deadlines for 2027 and 2028? • Did your company meet the critical May 26, 2024, application deadline? • Was a signed agreement with a Notified Body in place by September 26, 2024? • What does "maintaining compliance" truly mean for legacy devices in 2025? • Are there new EU MDR filings required in 2025 for the extension? • How does post-market surveillance change for legacy devices under these extensions? • What happens if significant changes are made to a legacy device? • What are the consequences of not meeting the 2024 prerequisites? • How can manufacturers ensure their QMS remains MDR-compliant throughout 2025? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    5 分
  • EU IVDR: Strengthening Your MedTech Supply Chain Controls

    EU IVDR: Strengthening Your MedTech Supply Chain Controls
    2025/05/29
    This episode delves into the critical supply chain requirements for Economic Operators under the EU's In Vitro Diagnostic Regulation (IVDR), referencing insights from April 14, 2025. We explore common pitfalls leading to Notified Body non-conformities, the specific obligations for manufacturers, importers, distributors, and authorized representatives, and strategies for ensuring your quality agreements and operational controls meet the stringent IVDR demands for enhanced traceability and patient safety in the EU market. Key Questions: • What are the four types of Economic Operators under EU IVDR and their core responsibilities? • Why are robust supply chain controls crucial for IVDR compliance and avoiding non-conformities? • Have the obligations for Economic Operators truly changed since May 2022, even for legacy devices? • What are the most common mistakes manufacturers make when defining Economic Operator roles and agreements? • How does EN ISO 13485 relate to controlling outsourced Economic Operator activities under IVDR? • What impact do new labeling, registration, and EUDAMED requirements have on IVD supply chains? • How can you ensure your quality agreements are up-to-date with IVDR Article 10-16 obligations? • Why is an existing ISO 13485 certificate not a guaranteed pass for supply chain audits? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    5 分
  • Unlocking Worldwide IVD Access with Europe's IVDR

    Unlocking Worldwide IVD Access with Europe's IVDR
    2025/05/28
    This episode explores how the European Union's stringent In Vitro Diagnostic Devices Regulation (IVDR) can strategically benefit IVD manufacturers seeking market access beyond the EU. We discuss leveraging IVDR CE Marking for easier entry into global markets, the role of harmonized quality management systems like ISO 13485, and the importance of a proactive global market access strategy in light of evolving international regulations, including the US FDA's QMSR effective February 2, 2026, and UK acceptance of CE marks until June 30, 2030. Key Questions: • How can the demanding EU IVDR actually simplify global market entry for IVD devices? • What is the significance of ISO 13485 in achieving broader international compliance? • How will the US FDA's QMSR, effective February 2, 2026, impact manufacturers with EU IVDR certification? • Which non-EU countries might recognize or streamline approvals based on an IVDR CE Mark? • Why is IVDR compliance becoming critical as legacy devices lose acceptance globally? • What are the key components of a successful global market access strategy for IVDs? • How can regulatory intelligence help IVD companies navigate complex international markets? • What opportunities does IVDR CE Marking create for accessing markets in Asia, Africa, the Middle East, and Latin America? • How long will the UK continue to recognize CE marking for market access (until June 30, 2030)? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 分
  • Leveraging Real-World Data: MHRA's Blueprint for Clinical Trials

    Leveraging Real-World Data: MHRA's Blueprint for Clinical Trials
    2025/05/27
    This episode delves into the UK's Medicines and Healthcare products Regulatory Agency (MHRA) guidance, updated 20 May 2025, on utilizing Real-World Data (RWD) in randomised controlled trials for regulatory decisions. We explore the scope, design considerations, safety monitoring, and regulatory acceptability of RWD-based trials, highlighting their potential to streamline drug development, particularly for label expansions and repurposing existing medicines. Key Questions: • What is the MHRA's latest stance on using Real-World Data in clinical trials as of May 2025? • How can RWD potentially reduce burdens and accelerate regulatory submissions for medicinal products? • What are the critical design elements for a successful RWD-based randomised controlled trial? • When might blinding be necessary in RWD studies, and why? • How does the MHRA view the evidentiary value of RWD trials compared to traditional RCTs? • What are "Type A" clinical trials, and how does this classification impact safety reporting requirements? • What are some of the most suitable scenarios for leveraging RWD in clinical investigations, such as drug repurposing? • Are there specific considerations for designing non-inferiority trials that use RWD sources? • How is the guidance expected to evolve concerning medical devices and RWD? • Where can sponsors obtain further advice from the MHRA on their specific RWD trial proposals? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30 + markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    5 分
  • Navigating MHRA's 2025 Real-World Data Guidance for UK Clinical Trials

    Navigating MHRA's 2025 Real-World Data Guidance for UK Clinical Trials
    2025/05/26
    This episode unpacks the UK MHRA's updated May 20, 2025, guidance on employing Real-World Data (RWD) in clinical studies for regulatory approval. We discuss the scope, the critical emphasis on data quality, essential considerations for sponsors using RWD sources like EHRs and wearables, and how the MHRA is shaping the future of evidence generation for medical products. Key Questions: • What exactly is Real-World Data and how is it changing regulatory submissions? • According to the MHRA's 2025 update, what defines high-quality RWD for clinical studies? • What are the major advantages and potential pitfalls of integrating RWD into your development strategy? • Which specific data quality aspects must sponsors meticulously address in their RWD study protocols? • How are emerging digital health technologies influencing RWD collection and its regulatory acceptance? • What scrutiny can be expected from MHRA during inspections of clinical trials utilizing RWD? • When is it advisable to proactively seek scientific advice from the MHRA on your RWD plans? • How can leveraging RWD ultimately streamline the path to market for new medical innovations? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of Brazil’s ANVISA process—and 30 + other markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 分
  • Wireless MedTech: Navigating Global RF Compliance

    Wireless MedTech: Navigating Global RF Compliance
    2025/05/25
    This episode offers medical device manufacturers an essential overview of navigating global wireless compliance when integrating radio frequency (RF) modules. We explore crucial considerations from selecting RF module suppliers and understanding international certification pathways—like modular versus system-level approvals—to compiling necessary documentation and addressing specific restrictions for medical applications. Learn how early planning and a clear understanding of each target market's regulations can streamline your path to launching wireless medical devices worldwide. Key Questions: • What are the first steps when planning international wireless compliance for your medical device? • How can you effectively vet RF module suppliers for global markets? • Modular vs. System-level approval: Which path is right for your wireless device and what are the hidden complexities? • What critical documentation will you need from your RF module supplier for international submissions? • Are there unique regulatory challenges when using wireless modules in medical applications, like data transmission or SAR? • How do you ensure your wireless medical device meets varying country-specific technical standards? • What strategies can help avoid costly delays in getting your wireless medical device to global markets? • Who typically owns the RF module certification, and does it need to be transferred? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of wireless compliance and global market access for medical devices—in over 30 markets worldwide, including complex regions for RF certification. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    5 分