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🔬 Navigating the New Norm: FDA Oversight of LDTs 🔬 The landscape of Laboratory Developed Tests (LDTs) is shifting. With the FDA set to phase out enforcement discretion, labs must understand the implications of the new IVD regulatory paradigm. Our blog post, "A Product Development Plan for my Laboratory Developed Test," delves into the anticipated changes and offers a strategic guide for transitioning from CLIA-certified LDTs to FDA-cleared/approved IVDs. Discover the essential steps for a robust Product Development Plan (PDP), the importance of gap analysis, and how to align with the new FDA rule. Whether you're a device manufacturer or a CLIA lab, this post is your roadmap to navigating the evolving regulatory landscape. 👉 Stay ahead of the curve and ensure your LDTs meet the new standards. Read the full blog now: https://lnkd.in/g-MaJXcW #LDT #IVD #FDARegulations #MedicalDevices #ProductDevelopment #NAMSAKnows

#RegUpdatesWithRegDesk From January 1, 2024, the medical equipment registration process in Israel, including Class I (I, Is, Im, Ir) and low-risk IVD laboratory equipment, has shifted to a self-declaration route by shareholders and importers. Registration holders or importers must attach a signed declaration (no need for an attorney's signature). This registration applies only to medical equipment registered and marketed in recognized countries. The declaration route ensures immediate confirmation via the vaults portal. The registration holder or importer is responsible for independently transferring applications in the normal route and awaiting review in the normal route to the declaration route. Follow: 👉 RegDesk and get daily regulatory alerts sent straight to your inbox. Get Started: 👉  https://lnkd.in/gxfStEAv #MedicalDevices #ivd #registeration #declaration route #regulatoryaffairs #import #amar #israel #2024

Listen back to our ‘IVDR Regulatory Updates – where do we stand 18 months after DoA?’ webinar, presented by Alex Laan, Head of IVD Notified Body. In this webinar we discussed the latest IVDR regulatory updates, a short recap on where the IVDR is and envision the potential ramifications for manufacturers of these updates. Access the recording and slides, here: https://bit.ly/3N1FcGI #BSI #MedicalDevices #IVDR #IVDRUpdates

Listen back to our ‘IVDR Regulatory Updates – where do we stand 18 months after DoA?’ webinar, presented by Alex Laan, Head of IVD Notified Body. In this webinar we discussed the latest IVDR regulatory updates, a short recap on where the IVDR is and envision the potential ramifications for manufacturers of these updates. Access the recording and slides, here: https://lnkd.in/eA83MEHm #BSI #MedicalDevices #IVDR #IVDRUpdates

Some key tips for IVD manufacturers from the Dutch IGJ: Improve PMS compliance. > If you have not already done so, take immediate steps to comply with the IVDR requirements relating to vigilance and PMS. Avoid delays in the certification process. > Make sure your communication with NB is fast and effective. > Make sure your technical documentation is complete, accurate and well structured. Contact an IVDR NB to arrange an assessment procedure. They do have capacity at the moment. See NANDO list: https://lnkd.in/eGrPFspK You need help? Contact us at welcome@astracon.eu. #ivd #ivdr #medicaldevices #astracon #regulatoryaffairs

📣 News from the FDA: they're aligning their quality system regulations with the International Organization for Standardization (ISO) guidelines. This means a step toward global best practices in manufacturing, ensuring the products you use every day meet the highest standards of quality and safety. Get the full scoop on how this update could affect the diagnostics industry and what it means for IVD products. Click to delve into Ron Shinkman's informative article! 🔗 https://lnkd.in/eu9SvmSz #Healthcare #QualityStandards #FDAUpdates

Listen back to our ‘IVDR Regulatory Updates – where do we stand 18 months after DoA?’ webinar, presented by Alex Laan, Head of IVD Notified Body. In this webinar we discussed the latest IVDR regulatory updates, a short recap on where the IVDR is and envision the potential ramifications for manufacturers of these updates. Access the recording and slides, here: https://lnkd.in/e_7jghXi #BSI #MedicalDevices #IVDR #IVDRUpdates

Listen back to our ‘IVDR Regulatory Updates – where do we stand 18 months after DoA?’ webinar, presented by Alex Laan, Head of IVD Notified Body. In this webinar we discussed the latest IVDR regulatory updates, a short recap on where the IVDR is and envision the potential ramifications for manufacturers of these updates. Access the recording and slides, here: https://lnkd.in/gtuRaPxu #BSI #MedicalDevices #IVDR #IVDRUpdates

Listen back to our ‘IVDR Regulatory Updates – where do we stand 18 months after DoA?’ webinar, presented by Alex Laan, Head of IVD Notified Body. In this webinar we discussed the latest IVDR regulatory updates, a short recap on where the IVDR is and envision the potential ramifications for manufacturers of these updates. Access the recording and slides, here: https://lnkd.in/gVK92rEG #BSI #MedicalDevices #IVDR #IVDRUpdates