Jon Lendrum

Is the MDR/IVDR burden finally easing up? (It’s about time!) 💡 ​New proposed revisions from the EU suggest a dramatic shift toward a more pragmatic approach. Here is what’s on the table: ​🌐 Remote Audits: Moving toward a standard option—saving massive time and logistics. ​⏳ Biennial Audits: Surveillance audits every 2 years instead of every year. ​📊 Clinical Data Relief: Greater reliance on existing data (reducing the endless PMCF cycle). ​♾️ No Expiry Dates: Eliminating the 5-year CE renewal. Certificates stay valid subject to compliance. ​📲 Going Digital: Official expansion of e-IFUs and digital labeling. ​The proposal is expected to move through a legislative path during 2026. 🚀 It seems the EU has finally realized they overdid it and that the current process had become unbearable. There might actually be light at the end of the tunnel. 🔦 https://lnkd.in/dkrtS_rj ​#MDR #IVDR #MedicalDevices #RegulatoryAffairs #MedTech #QualityAssurance​

14

5 Comments

Important update for those in medtech and digital health: The FDA just released new cybersecurity guidance for connected medical devices. This is a critical shift in how cybersecurity will be evaluated in premarket submissions—and it’s something all developers and manufacturers should take note of. 👇 Highlights and link below.

4

Hand Hygiene compliance is the key to reducing HAI's. We seem to be spending an inordinate amount of time and capital on figuring out how to force HCW's to use Hand Hygiene products they do not want to use. Maybe if there was Hand Hygiene products that were convenient and that didn't cause Eczema and Hand Dermatitis, all of this would not be necessary. And yet we continue to insist that we find new and innovative ways to either condition HCW's to use a product they spend so much time to avoid using or to punish them if they don't. Did anyone else read "1984" by George Orwell and see hand hygiene compliance programs as "Big Brother". Instead of spending all of this effort on new and better compliance programs that give incremental compliance increases we could just switch Hand Hygiene products from ABHR that causes Dermal Damage that increases users probability of harmful pathogen transmission. When ABHR causes Dermal Damage, it opens skin cracks that allows Bacterial and Viral pathogens like Norovirus to infect them and to make matters worse ABHR doesn't kill Norovirus. So basically, Hand Hygiene compliance programs that force HCW's to use ABHR that damages their hands they are potentially increasing HAI's. What is the logic in continuing to do the same thing over and over and expecting better results. I believe this is called insanity. Especially when there is a solution that could be implemented if the C Suite would actually listen to HCW's and insist that Hand Hygiene products do not cause Dermal Damage and actually have Non-Enveloped Viral efficacy. The solution is FDA-Cleared Antimicrobial HOCl Hand Hygiene. Even though HOCl has testing that validates Hand Sanitizer efficacy including Norovirus, which is the leading cause of Gastrointestinal HAI's, and can even heal hands damaged by ABHR, it is not in the FDA Hand Hygiene monograph and so it cannot be called a Hand Sanitizer, so Healthcare is worried about using a hand hygiene product with better efficacy and doesn't cause the dermal damage that causes companies and researchers to find ways to force HCW's to use products that they only use because they have no choice. Besides increased efficacy, HOCl is also used as a Wound Cleanser which only requires 510K Medical Device approval and is also an Eczema Therapy product that is Accepted by the National Eczema Association. Or we can keep coming up with new and innovative ways to force HCW's to use a product they despise and causes dermal damage along with inferior efficacy.

2

The preamble to the QMSR speaks directly about culture and FDA's expectations of "top management" saying: "FDA expects medical device manufacturers, led by individuals with executive responsibilities, to embrace a culture of quality as a key component in ensuring the manufacture of safe and effective medical devices…" Adding "A culture of quality meets regulatory requirements through a set of behaviors, attitudes, activities, and processes."   It's my experience that many executive leaders work hard to establish a culture of quality that serves their people and customers. It can sometimes be difficult to understand what's actually occurring, given perceptions around your position, title and accessibility. It's important to have people and processes in place to give you that "ground truth" to both address issues while celebrating successes. Your people talk with one another and their trusted peers - leaders must intentionally take steps to gain that same trust by "walking the talk" when it comes to your commitment to quality culture.   How would you assess the culture within your organization? In this article @Rebecca Fuller shares some thoughts on issues to pay attention to, with suggestions on how to address red flags.

15

MDCG 2021-25 Rev.1 Guidance Document This document outlines the application of MDR requirements to legacy devices and those placed on the market before May 26, 2021. It provides clarity on how manufacturers should comply with the updated regulations for these devices, ensuring ongoing safety and performance in the market. This guidance is essential for anyone involved in managing legacy devices within the medical device landscape. #MDCG #MDR #MedicalDevice #LegacyDevices #MedicalConsulting

15

🔐 FDA Releases Updated Cybersecurity Guidance for Medical Devices 🔐 This week, the FDA issued its final guidance on cybersecurity in medical devices, marking a pivotal shift in how cybersecurity is regulated and operationalized across the product lifecycle. As SVP of Regulatory Affairs at Monarch Medical Technologies, I see this as a transformative step, especially for teams developing and maintaining connected devices and SaMD platforms. The guidance doesn’t just recommend best practices, it now anchors many of them in statute. 📓 Here’s a quick summary of what’s new and why it matters: 📓 ☑️ Legal Grounding: For the first time, cybersecurity expectations are embedded in statute under §524B of the FD&C Act, making them legally enforceable. ☑️ Scope Clarity: The FDA has clarified what constitutes a cyber device (Section VII)—broadening the scope beyond traditional connected devices to include components like cloud services and software modules. ☑️ Documentation Requirements: Expectations are now explicit: threat models, SBOMs, architecture diagrams, vulnerability assessments, and justifications for updates must be included in submissions. ☑️ Modification Triggers: Cybersecurity changes may now independently trigger new submissions, even if they don’t directly impact safety or effectiveness. ☑️ Broader System Perspective: The FDA underscores that cybersecurity must extend beyond the device—to include networks, hosting infrastructure, and system-level interactions. 💡 Strategic Takeaways for Regulatory Teams:💡 ☑️ Evaluate early: Determine if your device qualifies as a cyber device under §524B(c). ☑️ Prepare comprehensive documentation: Threat modeling, SBOMs, and architecture mapping are no longer optional. ☑️ Manage changes proactively: Implement MDR processes that flag cyber-related modifications. ☑️ Adopt a systems-level view: Address how your device secures data and integrates within the clinical IT environment. This updated guidance will reshape how we prepare premarket submissions and manage postmarket cybersecurity. If you're navigating these changes or want to exchange ideas on adapting your regulatory strategy, I’d love to connect. https://lnkd.in/gAZiF3BA #FDA #Cybersecurity #MedicalDevices #SaMD #RegulatoryAffairs #DigitalHealth #CyberCompliance #SBOM #PremarketSubmissions #SystemSecurity #510k #QualitySystems #QMS #RiskManagement

13

1 Comment