RQM ’s Post

🔬 Exciting Developments in IVD Regulation! 🔍 MedTech Europe have acknowledged the European Commission's proposal for extending the In Vitro Diagnostic Medical Devices Regulation (IVDR) transitional periods and early mandatory use of the European medical devices database (EUDAMED) modules. MedTech Europe emphasizes the importance of this additional time for all stakeholders to identify and rectify issues, ensuring a seamless transition for manufacturers. The integrity of the EUDAMED database is highlighted as crucial for success. Four key conditions are outlined before making EUDAMED modules mandatory, emphasizing simplicity, EU-level management of device discontinuations, avoiding financial implications for manufacturers, and providing guidance for smooth implementation. As a recruiter involved in the IVD sector, I recognize the significance of these developments for our industry. It's a pivotal time, and discussions between stakeholders in 2024 will further drive lasting solutions, efficiency, innovation, and improved governance for the benefit of patients and European health systems. Let's continue to stay informed and engaged in the evolving landscape of IVD regulations! 💡🌐 #IVD #MedTech #RegulatoryUpdates #Healthcare #Diagnostics 

This is a quick reminder that the next FDA webinar on LDT is less than a week away. It will focus on test classification (Class I, II, or III). This is a critical session you will want to attend. Register here: https://lnkd.in/g8DS3qEu Additionally, there's an exciting announcement for the August webinar on medical device reporting (implementation milestone 1). At GenXys, we stay informed on these developments to serve our partners better and advance precision medicine. #FDA #webinar #LDT #medicaldevices #GenXys #precisionmedicine

Having gone through the NYS assay approval process once already, I have a decent idea about the sheer amount of work, from both the labs and the FDA, the proposed LDT rule from FDA will require. That alone should cause great concern to anyone in the US who needs or will need nonwaived lab testing (spoiler alert: that's just about everyone). The amount of time and resources that will be needed to meet the requirements of this proposed rule cannot be overstated and many, many labs will not be able to make it and stay in business. There's already a critical shortage of lab techs and, if the smaller labs go out of business, that will become a critical shortage of labs, period. As this article by Hyman, Phelps, and McNamara states, "The PR cites CDC’s report that “70 percent of medical decisions are based on laboratory test results.” Given the potentially massive impact of the proposed changes on a wide range of stakeholders, and indeed on the healthcare system, we strongly encourage interested parties to submit comments, which can be done using the provided link." https://lnkd.in/gEcZhvds

In case you missed it over the holidays, the FDA released updated draft guidance on utilizing Real-World Evidence (RWE). The guidance outlines how the FDA assesses real-world data (RWD) in regulatory decisions for medical devices and proposes enhanced recommendations for sponsors using RWE in regulatory submissions. Stakeholders can provide comments until February 20, 2024. With these and other regulatory changes being discussed in DC, connect with The Deerborne Group to understand how this might affect your plans. Click here to read more: https://lnkd.in/gsrJT5Q7 #fda #genomics #nextgenerationsequencing #venturecapital #privateequity #deerbornedifference

#Digitalhealth software can be built with the level of rigor to be an approved “#medicaldevice.”

In case you missed it over the holidays, the FDA released updated draft guidance on utilizing Real-World Evidence (RWE). The guidance outlines how the FDA assesses real-world data (RWD) in regulatory decisions for medical devices and proposes enhanced recommendations for sponsors using RWE in regulatory submissions. Stakeholders can provide comments until February 20, 2024. With these and other regulatory changes being discussed in DC, connect with The Deerborne Group to understand how this might affect your plans. Click here to read more: https://lnkd.in/gB3jh9bb #fda #genomics #nextgenerationsequencing #venturecapital #privateequity #deerbornedifference

Phase 1 Report out of the COMBINE Project! If you haven’t read it, check out the great Table of linked resources included as an Annex to Task 3 🔆

The FDA’s Q-Submission Program is a voluntary program that device manufacturers can use to obtain FDA feedback during device development, submission review, or even prior to starting a clinical study. Michelle Rubin-Onur, PhD, Enzyme Director of Regulatory, breaks down when you can and should use this program in our latest blog post: https://lnkd.in/gEsZFtap

Digital health technology (#DHT) is increasingly used in clinical trials to measure endpoints, to capture data, and to drive the conduct of decentralized clinical trials. Dr. Hans-Peter Podhaisky has just published an article on the current regulatory challenges with the interface of the EU Clinical Trial Regulation (#CTR) and the Medical Device Regulation (#MDR) for the deployment in drug trials of those DHTs that qualify as medical devices or medical device software (#MDSW). He also put forward 4 pragmatic proposals to support those combined studies. #COMBINE project solutions: ♦ Risk-Based Approaches for Low-Risk Devices and Exploratory use Cases ♦ Adaptation of MDR Rule 11 to Include Criteria for Low-Risk MDSW ♦ Clarity on Scenarios Requiring Clinical Investigation Applications under MDR Art. 62 and Art. 82 ♦ Integrated approach to combined study application leveraging national HA precedent (e.g. ANSM)