Matt Burton’s Post

🌐 With the MHRA unveiling its long awaited roadmap outlining the future regulatory framework for medical devices, how will your business tackle these changes? Regulatory uncertainty has hampered both innovation and investment in the UK. The new roadmap is an important step in providing momentum for the industry and a degree of clarity - though more work needs to be done and swift progress over the coming year will be critical. ABHI has fought for this update for years, providing regular input to the MHRA. The December 2022 agreement by senior members of the Life Sciences Council, including ABHI, was a key step in this journey, as were the later aligned proposals from March 2023. Predictable regulations are vital for successful market operation, and we are looking forward to supporting our members and the wider industry through this new regulatory landscape. For those that want to know more about how the current changes will affect them and their business, be sure to check out the analysis by our Chief Executive Peter Ellingworth. 👉 bit.ly/3HvfpUl #HealthcareInnovation #MedicalDeviceRegulations #UKHealthTech #MHRA #medicaldevice #MDR #IVDR #regulatoryaffairs #medtech #healthtech #biotech

Is your business prepared for these & other upcoming challenges? Seemingly every which way the regulatory landscape is set to change, MDR, UKCA, FDA to name a few Why not let us help with determining the right path for your regulatory journey, contact us for a no obligation conversation…..

I'm honored to announce that I will be a speaker at the "𝟮𝟬𝟮𝟰 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗮𝘁𝗵𝘄𝗮𝘆𝘀 𝗩𝗶𝗿𝘁𝘂𝗮𝗹 𝗦𝘂𝗺𝗺𝗶𝘁" on February 7th, 10 a.m. EST Register Now:  https://lnkd.in/gNws7_TK This 2-hour virtual summit is a unique opportunity to gain strategic insights into those pesky, ever-changing #medtech regulations affecting the EU, the U.S., and the U.K. Here's a sneak peek of what I'll be discussing: 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗙𝗗𝗔 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀: Insights into the current FDA regulatory landscape and how it impacts MedTech innovations. 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Practical advice on maintaining compliance with evolving U.S. regulations. 𝗚𝗹𝗼𝗯𝗮𝗹 𝘃𝘀. 𝗨.𝗦. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗣𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝘀: Comparing and contrasting U.S. regulations with global standards to aid in strategic decision-making. Join us for a dynamic exploration of MedTech regulations and how they are shaping the industry's future. This is a must-attend event for anyone in the MedTech field looking to stay ahead in #regulatoryaffairs. See you there! *This webinar will be recorded and made available to all registrants. #MedTech #RegulatoryAffairs #FDA #VirtualSummit #mlv

🌐 Spotlight on the US FDA Spring IMDRF Event🚀 Last month, ABHI and other Global Medical Technology Alliance members joined the global regulatory community in Washington to discuss trends and initiatives expected to shape the global HealthTech regulatory landscape. ABHI engaged with decision makers at IMDRF, championing the need for a more aligned global HealthTech regulatory landscape to support cutting-edge health technologies in the UK and beyond. What were your biggest takeaways from IMDRF? Learn more about which industry events ABHI attends here 👉 https://bitly.cx/4wrz #imdrf #healthtech #meditech #innovation

🚀 Less than 24 hours... It's not too late to register for "2024 MedTech Regulatory Global Pathways Virtual Summit," presented by Market Pathways and MedTech Leading Voice. Register now: https://lnkd.in/gDSih8JR This is your opportunity to gain unique strategic insights into MedTech regulations across the EU, the U.S., and the U.K. It will feature presentations and discussions from three great experts: Matt Burton on UK and Northern Ireland, Gert Bos, PhD, FRAPS on the EU Michelle Lott, RAC on the US FDA - Expert Discussions: Guiding talks with top MedTech regulatory experts. - Global Perspectives: Synthesizing global and regional regulatory insights. - Roundtable Insights: Facilitating dynamic discussions on regulatory strategies. Join me (and moderator David Filmore!) for an exploration of MedTech regulations and their impact on the industry. *This free webinar will be recorded and made available to all registrants. hashtag #MedTechSummit hashtag #RegulatoryInsights hashtag #HealthcareModerator hashtag #mlv hashtag #fda hashtag #regulations

Several Ministers of Health recently called for EUDAMED (the EU medical devices database) to be made mandatory. Read the open letter from 6 EU medtech trade associations - AESGP, COCIR, EHIMA, EUROM, EUROMCONTACT and MedTech Europe - where we highlight important preconditions that are needed before any modules become mandatory:  1. The modules are fully developed, tested, audited and ready for practical implementation. 2. EUDAMED enables the most efficient use of Notified Body and Manufacturer resources. 3. Realistic and reliable implementation and transition timelines are provided. 4. Redundancy in National Databases is eliminated. Here is a link to the joint open letter: https://lnkd.in/ecVExmDX #eudamed #mte #ivdr #mdr

The healthcare ecosystem is increasingly shaped by international collaboration between industry, health technology assessment (HTA) bodies, and regulators. Initiatives like EUnetHTA 21 and the FDA’s Project Orbis exemplify the power of aligning standards to streamline market access, improve efficiency, and accelerate the availability of life-saving therapies globally. Closer to home, I’m proud of the Industry Task Force we recently launched at Canada's Drug Agency . This time-limited initiative sparked more meaningful dialogue between industry, HTA, and regulatory bodies, laying the groundwork for greater transparency and shared decision-making. It’s a crucial step in harmonizing efforts to ensure that patients benefit from timely access to innovation. By working together across borders, we can reduce duplication, improve outcomes, and meet global health challenges head-on. 🤝 #GlobalHealth #HTA #RegulatoryAffairs #HealthcareInnovation #Collaboration #IndustryTaskForce #EUnetHTA #ProjectOrbis #PMDE

The European Union's new #HTA Regulation introduces the Joint Clinical Assessment (#JCA), a harmonized approach to clinical evaluations that will reshape the way biotech and medtech companies navigate the Market Authorization Application (MAA) process.    We are excited to invite you to our upcoming webinar on a key development that will transform Marketing in Europe: "How to Master both Marketing Authorization and Joint Clinical Assessment Successfully". 🗓 Date & Time: Oct. 17th, 13:00 CET 📢 Format: Online session 👉 Free registration: https://lnkd.in/ePKqFAZN Decebal Bora, Gabrielle Nayroles, Christelle Fasano, Susan Benjamin, Saku Torvinen, PhD, Linsen Du #Regulatory #MarketAccess

📢📅 We're excited to announce an upcoming webinar by Voisin Consulting Life Sciences (VCLS) titled "How to Successfully Master Both Market Authorization and Joint Clinical Assessment." Don't miss out—register now and gain valuable insights! #MedEngine #TheValueIsInTheLinks #VCLS #MarketAccess

#RegulatoryUpdates 📌 On February 16th, 2024, the Council of the European Union officially endorsed without any changes the proposal published on January 23rd, 2024, by the European Commission to amend #IVDR and #MDR extending the transitional provisions for certain #invitrodiagnostics, a gradual roll-out of #Eudamed and the obligation of manufacturers to inform #competentauthorities and #economicoperators in case of interruption of supply. The next and final step is the European Parliament’s endorsement and publication of the adopted text in the Official Journal of the European Union. 𝐇𝐨𝐰 𝐝𝐨𝐞𝐬 𝐭𝐡𝐚𝐭 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥𝐥𝐲 𝐚𝐟𝐟𝐞𝐜𝐭 #medtech #biotech 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫𝐬? 👉 Extension of the transitional provisions for certain IVDs under specific conditions • For Class D until 31 December 2027 • For Class C until 31 December 2028 • For Class B and Class A sterile until 31 December 2029 👉 Gradual roll-out of #Eudamed:  gradual roll-out of the electronic systems integrated into the EUDAMED that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed.  ❗ 𝘛𝘩𝘦 𝘯𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘳𝘦𝘨𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘳𝘦𝘲𝘶𝘪𝘳𝘦𝘮𝘦𝘯𝘵𝘴 𝘦𝘯𝘥 𝘸𝘩𝘦𝘯 𝘵𝘩𝘦 𝘳𝘦𝘨𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘳𝘦𝘲𝘶𝘪𝘳𝘦𝘮𝘦𝘯𝘵𝘴 𝘪𝘯 𝘌𝘜𝘋𝘈𝘔𝘌𝘋 𝘴𝘵𝘢𝘳𝘵 𝘵𝘰 𝘢𝘱𝘱𝘭𝘺. 👉Manufacturers of medical devices and IVDs will need to inform their Competent Authority and #healthinstitutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or #healthcareprofessionals, they should inform the relevant #economicoperators in the supply chain, which then can inform the health institutions. Read more: https://lnkd.in/d8Zrgf2R