Tom Melvin’s Post

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

How do we move forward from MDR/IVDR? Very interesting start to Irish medtech #globalaccess2024 discussion chaired by Amanda Maxwell and Melissa Kann, RAC framing the idea of a need for continuous improvement and a sensible way forward… Ideas discussed with Amanda Maxwell Niall MacAleenan Merlin Rietschel Derick Mitchell Erik Vollebregt Sabina Hoekstra-van den Bosch, PharmD FRAPS Robbie Walsh @alan fraser - Opening up the recertification cycle - Enabling notified bodies to be more transparent with what they are doing and how? - Assigning more resources at EU level to deal with the implementation - Reducing timelines for conforming assessments - having a breakthrough device pathway - electronic IFU - More transparency with clinical data - Centralisation / harmonization 😏 What other measures do you all see?

TOMORROW ONLY Free Webinar: EU vs. US Clinical Data Insights Join us for a deep dive into the differences in clinical data requirements for medical devices between the EU and US with MedTech Leading Voice's Sean Smith and Market Pathways's David Filmore. Our expert speakers will break down the key distinctions and share practical insights on what they mean for compliance. You’ll also get real-world examples and strategies to navigate these varying regulations. Whether you're planning to enter either market or just staying informed, this webinar will give you the tools to understand and tackle these challenges. Key topics include: - Major differences in EU vs. US clinical data requirements - Practical impact of these differences on market entry - Case studies on navigating compliance Plus, get the latest updates on ISO 14155 revisions and the evolving clinical evaluation standards in Europe. Register to attend today: https://bit.ly/3XhNPBe #medtech #medicaldevices Maria E. Donawa, M.D. Tom Melvin

⚡️Regulatory News from USA: Make sure to examine the Final guidance for industry entitled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations". Subscribe now to read the full story: https://lnkd.in/dUiFxgap #clinicalinvestigations #usfda #digitalhealthtechnologies #regulatoryaffairs #medizinprodukte #medicaldevices #dispositivosmedicos #dispositivimedici #dispositifsmedicaux

On 20 November 2024, our CEO, Oliver Bisazza, participated in POLITICO Healthcare Summit’s spotlight discussion on “Getting the medical devices regulation right”.   During a very interactive discussion, the panellists agreed that patient safety is at the heart of the MDR and IVDR regulations, but certain measures must be taken to improve its efficiency.   Oliver outlined the challenges of the current #MDR and #IVDR framework on the #medtech sector, including the risk that up to 1 in 3 medical technologies may be discontinued unless action is taken now. “It is no surprise that innovation is going to other parts of the world. We are asking Europe to catch up on good examples.“   We are extremely supportive of the attention the EU Institutions are giving to addressing the challenges of the current framework, and we call on policymakers to take decisive action to ensure that innovation reaches patients and healthcare systems in Europe. #POLITICOHealthCare

📢 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

Clinical trials are the backbone of medical progress, yet Europe's system faces hurdles that can slow down innovation. A recent article by Sifted https://lnkd.in/ehJ3y9Ex explores these challenges and proposes solutions for a more efficient future. The article highlights the need for streamlined regulations, improved collaboration across borders, and leveraging technology to expedite the clinical trial process. By overcoming these obstacles, Europe can ensure faster access to life-saving treatments for patients. Head over to the full Sifted article to delve deeper into the current state of clinical trials in Europe and the exciting possibilities for an optimized system. #Planimeter #ClinicalTrials #Europe #BlogRecap

A Step Forward for Medical Device Safety and Access in Europe ✅ On October 23, 2024, the European Parliament approved a significant revision of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). This revision is crucial for addressing the current challenges regarding the safety and accessibility of medical devices in Europe. Why is it important? Small and medium-sized enterprises have faced significant obstacles, including the limited capacity of notified bodies and administrative complexities that have delayed access to vital devices. These updates aim to enhance transparency, support innovation, and ensure equitable access to essential devices. What to expect from the new regulation: ✔ Increased transparency in the evaluation process conducted by notified bodies. ✔Simplification for Small and medium-sized enterprises to foster innovation and rapid market access. ✔Data protection in digital health applications. ✔Clear definitions and processes for "orphan devices." ✔Full implementation of the EUDAMED database for better accessibility to information. These changes represent a fundamental step towards ensuring that the health of EU citizens is prioritized. Discover how these modifications will impact the sector and how we can assist you in navigating these new regulations by reading our full article in the News section of our website https://lnkd.in/eChpQ9fE

Europe's regulatory system can be a brake or an accelerator in bringing new treatments to patients. As we look toward 2030, what tools and knowledge does Europe need to thrive in an ever-evolving clinical trial environment? Read more in this blog by Thomas Metcalfe, Stefan Schwoch and Max Wegner: https://bit.ly/3QP9i2a #ICTD2024 #WeWontRest