AiM GmbH - Assessment in Medicine’s Post

Restricted market access and sub-optimal reimbursement can limit your medtech’s potential. Without the right codes, coverage, and reimbursement, doctors simply won't adopt your device. To overcome these barriers, you need to tackle them early in the launch process. In this on-demand webinar, my DH colleagues will walk you through best practices for market access assessment, share essential tools to keep your plan on track, and give you tactics to engage with key decision-makers. Give the webinar a look! https://lnkd.in/e6EV3uW5 #medtech #marketaccess #medicaldevices #meddevicesales

🔔 Big News! Go-Live for the swissdamed Actors Module We are pleased to announce that the first module of the swissdamed medical devices database will go online in August 2024. 🎉 📅 26.06.2024 Since the Mutual Recognition Agreement (MRA) with the EU has not been updated, Swissmedic has not had access to the European database EUDAMED3. As a result, since May 26, 2021, Swiss economic operators (manufacturers, importers, and authorized representatives) have needed to register with Swissmedic to obtain a Swiss Single Registration Number (CHRN). 💡 Change in Current Practice Starting August 6, 2024 From August 6, 2024, the swissdamed Actors module will be available for the registration of economic operators. This significant change will eliminate the need for PDF forms and allow the entire registration process to be conducted online through www.swissdamed.ch. 🗓️ Key Dates Until July 26, 2024: Applications for registration and changes to the CHRN, as well as mandate notifications, will be accepted as PDF forms until this date. From August 6, 2024: The swissdamed platform will be used exclusively for the registration of economic operators, replacing the CHRN@swissmedic.ch email inbox with an online contact form. 👥 What Does This Mean for Registered Operators? The data for the nearly 3,700 economic operators already registered with Swissmedic will be automatically migrated. In early August, these operators will receive a letter with detailed instructions on the next steps. They will not need to register again, only verify their data once it has been imported into swissdamed. 📦 Future of Device Registration In June 2024, a group of manufacturers and agencies that issue UDIs were invited to test the first upload options for devices. In 2025, Swissmedic plans to launch additional sections of swissdamed for the voluntary registration of certain devices, with a view to mandatory registration in the future. This advancement will enhance transparency and provide an overview of the range of devices available on the Swiss market. ➡ Info Sources: https://lnkd.in/dKVmtvFC ✅ For more information on all regulations related to Switzerland, please visit our website: https://lnkd.in/dEPSncHD #Swissmedic #swissdamed #MedicalDevices #Regulation #Health #Innovation

Restricted market access and sub-optimal reimbursement can limit your medtech’s potential. Without the right codes, coverage, and reimbursement, doctors simply won't adopt your device. To overcome these barriers, you need to tackle them early in the launch process. In this on-demand webinar, my DH colleagues will walk you through best practices for market access assessment, share essential tools to keep your plan on track, and give you tactics to engage with key decision-makers. Give the webinar a look! https://lnkd.in/eNFekiax #medtech #marketaccess #medicaldevices #meddevicesales

📢 UK medical device reforms – direction of travel 📢 🏥The UK’s medical devices regime is undergoing an extensive reform process, with the recent publication of regulations to improve post-market surveillance systems. 🔍At a recent speech to techUK Health & Social Care, Laura Squire OBE, Chief Healthcare Quality and Access Officer at the MHRA highlighted some of the forthcoming changes. Read Steph Caird's blog where she summarises the amendments coming down the track: ⤵️ https://lnkd.in/eF8FrncJ #MedicalDevices #Reform

Our latest quarterly newsletter is out, and we’re proud to share another exceptional quarter of good news for the medical device reprocessing industry! https://lnkd.in/gCXUUk99 Here’s what we're most excited about: ✅ New AMDR member data reveals that 11,967 hospitals and surgical centers in 15 countries saved nearly half a billion dollars in 2023 by reprocessing single-use devices. ✅ The UK's Department of Health and Social Care has unveiled their 'Design for Life Roadmap,' setting the ambitious goal of completely phasing out single-use devices by 2045 - and advocating for greater use of reprocessed ("remanufactured" in the UK) devices as a key pillar in their strategy for building a circular healthcare system. ✅ The Food & Drug Administration published an online resource clarifying that the "single-use" label does not, in fact, mean that a device cannot be safely reprocessed. For the full breakdown and insights from U.S. and global leaders in sustainable healthcare, read our full newsletter: https://lnkd.in/gCXUUk99 #SustainableHealthcare #Sustainability #Healthcare #CircularEconomy #MedicalDevices

Restricted market access and sub-optimal reimbursement can limit your medtech’s potential. Without the right codes, coverage, and reimbursement, doctors simply won't adopt your device. To overcome these barriers, you need to tackle them early in the launch process. In this on-demand webinar, my DH colleagues will walk you through best practices for market access assessment, share essential tools to keep your plan on track, and give you tactics to engage with key decision-makers. Give the webinar a look! https://lnkd.in/e3X98wMX #medtech #marketaccess #medicaldevices #meddevicesales

I’m excited to share that Wolf Theiss has just released their Guide to Medical Devices in CEE & SEE, offering an in-depth look at the regulatory landscape shaping the medical device industry across the region. This comprehensive guide dives into the current challenges, highlights areas of progress, and outlines the key regulatory updates to watch for.

The MDR/IVDR has been with the industry for some time now. If you’re curious about how its implementation has unfolded across the CEE & SEE regions, I invite you to explore our guide! From key developments and opportunities shaping the sector to upcoming challenges, national implementation specifics, and the rise of AI-powered devices just around the corner – it’s all covered 🚀

The journey to modernising healthcare through medical devices in Central, Eastern and Southeastern Europe is marked by both complexity and opportunity. In our newly released Guide to Medical Devices in CEE & SEE, we delve into the regulatory challenges that shape the medical device industry in the region, providing insights into the existing hurdles, areas of progress and anticipated regulatory updates. Tap into the expertise of industry leaders. Download our Guide to unlock the keys to CEE & SEE medical device market success via 🔗 https://wt.legal/ReTB #WolfTheiss #SEE #CEE #MedicalDevices #MedTech #Healthcare #HealthTech #HealthcareIndustry

43% That’s the percentage of people in the UK healthcare system who have had to wait 4+ hours in A&E in 2024. 🤯 By comparison, in 2014, that percentage was less than 10% 😲 It's a no brainer to be working alongside Doctor Pocket, as they expand across Europe and EMEA. 🏥 When I first heard about their innovative telemedicine platform, which drastically reduces wait times for medical services, I was sold. 🤝 My dad has been a pharmacist for the past 30 years, so I have seen firsthand the pressures and stresses which go hand in hand with skyrocketing wait times, and poor resource management. 📈 By implementing Doctor Pocket into your clinic’s healthcare practice, you save not only money and time. You save lives. ❤️ Fluency Fiesta and Doctor Pocket are an ideal match. 📝 We both understand the need to integrate cutting-edge technology with real human interaction, no matter the location. 🌍 So, to my medical and pharmaceutical contacts in the UK, Europe and the Middle East, get in touch! We have a solution to your problems! 👇 Jeffery Khoury- DP Bill Cossart