MedTech Europe’s Post

📢 Today, MEPs adopted a resolution in the European Parliament calling on the Commission to implement urgent measures to address pressing issues in the #MDR implementation. BioMed Alliance agrees that steps within the current legislative framework must be taken to tackle urgent issues and improve patient access to life-saving medical devices.    But it’s not just about short-term fixes.The Commission must also take its time to conduct a thorough evaluation of MDR & IVDR with key stakeholders, and come up with a legislative proposal for reform addressing longstanding structural issues.   📅 Do you want to contribute to the conversation? Join us at our upcoming workshop 'Future Directions of MDR & IVDR', where we can jointly discuss issues in the system and potential solutions with key stakeholders. Register here https://lnkd.in/dpJtUEx5   #MDR #IVDR #Regulation #Workshop

We stand with Biomedical Alliance in Europe in expressing concerns over the accelerated evaluation of the Medical Devices Regulation (MDR). 🚨 Rushing this process may compromise patient safety and the integrity of the Medical Devices Regulation (MDR), which is essential for ensuring safe and effective medical devices in radiology and healthcare. Key Points: 🛡️ Patient Safety First: reliable MDR standards ensure imaging devices meet high performance criteria, leading to more accurate diagnoses. 💉 Addressing Device Shortages: addressing device shortages helps radiologists access essential tools and devices. 🚀 Promoting Innovation in Imaging Technologies: tackling structural issues ensure continuous innovation in imaging technology in Europe. 🔗 You can read the full statement here: https://lnkd.in/dGzCX8Dd We will continue to monitor EU developments closely to ensure and advance radiology standards across Europe.

🔍 Dive into the latest insights on UK medical device regulations and NHS DTAC updates from our recent meetings with NHS England and the MHRA! 🚀 Discover how the evolving landscape impacts manufacturers and the broader digital health technology field. 🇬🇧💡 🔗 Read our full analysis and takeaways #MedicalDevices #HealthTech #RegulatoryUpdates #NHS #MHRA #DigitalHealth #Innovation #UKRegulations 👉 Join the conversation and share your thoughts on these important developments!" https://wix.to/sNE6gxO

🔍 Dive into the latest insights on UK medical device regulations and NHS DTAC updates from our recent meetings with NHS England and the MHRA! 🚀 Discover how the evolving landscape impacts manufacturers and the broader digital health technology field. 🇬🇧💡 🔗 Read our full analysis and takeaways #MedicalDevices #HealthTech #RegulatoryUpdates #NHS #MHRA #DigitalHealth #Innovation #UKRegulations 👉 Join the conversation and share your thoughts on these important developments!" https://lnkd.in/ehEAc677

Would love to see a more common sense approach to the grey area of MHRA and DCB0129/0160 in relation to digital clincial safety and the point of where a medical device ends and data management begins in digital technology, applications and software. Exploring a combined Clincial Safety team with a cross section of MDSO, MSO, CSO, Patient Safety and Information Governance is still a distant reality unless the applied funding supports trusts in delivery of the ever increasing demands from interoperability and integration of systems (device or software).

🚨Plans made in haste to change medical device regulations risk further neglecting the needs of patients who rely on medical technologies 🚨 Following the recent European Parliament plenary session, BioMed Alliance has published a statement expressing concerns about the push to accelerate the evaluation of the Medical Devices Regulation (MDR). MEPs are calling on the European Commission to propose changes within 100 days. While we recognize the need to address urgent issues, we believe rushing the process could undermine patient safety and weaken the integrity of the MDR. The MDR was created to safeguard the safety and effectiveness of medical devices through strict standards. While short-term actions are needed—especially regarding orphan and pediatric devices—hasty revisions risk neglecting deeper issues such as high certification costs, governance challenges, and innovation leaving the market. The BioMed alliance has released a statement with policy recommendations 👇 Find the complete statement on our website https://lnkd.in/dmH-H9kp   #MDR #MedicalDevices #PatientSafety #HealthcareInnovation #BioMedAlliance #EUHealthcare #IVDR

🚨 Attention Medical Device Innovators & Stakeholders! 🚨 The UK government is seeking YOUR input on important regulations impacting medical devices and in vitro diagnostic devices. This consultation is a key opportunity to help shape the future of the sector and ensure that the UK continues to foster a regulatory environment that supports innovation while safeguarding public health. 🔍 Why should you participate? Influence regulatory pathways for medical devices and diagnostics. Contribute to policies that will impact market access and the compliance process. Share your expert feedback on how to improve the framework for bringing life-changing devices to market. Your insights can make a real difference in streamlining processes, improving efficiency, and ensuring the regulations are fit for the rapidly evolving medical device industry. 👉 How to Get Involved: Visit the consultation page here: Consultation on Medical Devices Regulations: https://lnkd.in/da-mUgRa 📅 Deadline: Be sure to submit your views by the closing date to have your voice heard. Let's ensure the UK remains at the forefront of medical innovation and patient safety! #MedicalDevices #Innovation #HealthcareRegulations #IVDs #UKRegulations #MedicalTechnology #PolicyConsultation #HealthcareIndustry

MedTech Europe, together with 39 national associations, sent an open letter to Commissioner Stella Kyriakides asking for action on the #medtech regulations (IVDR and MDR) to ensure device availability and competitiveness of the sector for medical technologies. We ask for the Commissioner's leadership to make reform of these regulations her priority and to urge her successor to do the same to solve their ongoing serious implementation challenges. Action is needed to reverse the exodus of innovation from Europe and to prevent further discontinuations of medical technology intended to protect patient safety and public health: 1. A package of legislative reforms for each of the two regulations should be developed to ensure that these regulations deliver on their original objectives. 2. Several ‘bridging measures’ are urgently needed to support device availability and the viability of the medical technology industry. 3. Specific measures to improve the implementation of the regulations should continue to be pursued through existing work streams and tools. Read the open letter and our areas of action here ➡ https://bit.ly/4h64y3K

In Case You Missed It… Yesterday, I had the pleasure of presenting at the Clinical Data Requirements: EU vs. US webinar alongside Maria E. Donawa, M.D. and moderated by David Filmore During my talk, I discussed the evolution of clinical data regulations for medical devices in Europe and the US. For a summary of my presentation, check out the flipbook created by MedTech Leading Voice. Thank you Sean Smith for organising a very enjoyable session! #FDA #EUMDR #clinicaldata #IVDR #medicaldevices —-----------

I really enjoyed moderating this webinar yesterday with Tom and Maria E. Donawa, M.D. In addition to Maria's incisive points on dealing with the modern day MDR v. FDA dynamics, it was a rare treat to get a history lesson on US and EU #medtech regs from Tom. And I thought his primary takeaway is very interesting ---> Essentially, the US system was built initially out of a public health imperative (responding to safety risks) and developed based on Scientific evaluation. While the European system was originally built more for trade imperative (to establish the EU single market,) and relies more on Policy evaluation. This, he contends, explains some distinctions between the systems including, how FDA v. a notified body might consider appropriate clinical data requirements for a given device -- and, in particular, why the latter may be lacking in its ability to be flexible. 🤔 I probably don't do it justice, Tom, but I thought it was a point worth elevating! #medtech #EU #regulations Market Pathways