First Imaging’s Post

"Concerned that in vitro diagnostic manufacturers don’t have enough time to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the European Commission (EC) has again proposed extending the regulation’s transition period. At the same time, the Commission has proposed to accelerate the timeline for complying with EUDAMED requirements, by making the use of finalized modules mandatory on a gradual basis." #EU #EC #EUDAMED #InVitroDiagnostics #IVD #IVDR #MedicalDevices #MDR https://lnkd.in/eVwmnFvK

Back with another regulatory update! 📢 Last week, the Medical Device Coordination Group (#MDCG) released its third revision on the guidance for Classification Rules for In Vitro Diagnostic Medical Devices under the #IVDR. This revision is crucial for all IVD manufacturers uncertain about classifying their IVDs. It is especially important for those manufacturing specimen receptacles, as it offers further clarification on their #classification. 📄✔️ Learn more here 👉 https://hubs.li/Q02GJTFJ0

Despite its efforts to harmonize regulation, the EU Medical Device Regulation (#MDR) poses significant adherence challenges to the European #medtech space. Co-founder Meri Beckwith shares his thoughts in a recent article by Medical Device Network. Read the full article: https://lnkd.in/eQceCdqp #medicaldeviceresearch #regulatoryaffairs #EUMDR #cro #clinicaltrials

1. Imricor has successfully completed the US FDA review for its first premarket approval module ahead of schedule. 2. The Vision-MR Ablation Catheter 2.0 is awaiting final certification in Europe after a successful on-site audit. 3. The transition to the EU's more stringent Medical Device Regulations (MDR) is progressing smoothly and faster than expected. 4. The FDA accepted and closed the first premarket approval module for devices including the Vision-MR ablation catheter and RF-5000 ablation generator. 5. A positive on-site audit by TÜV SÜD recommended Imricor for certification under the new MDR regime. 6. The technical review for the Vision-MR Ablation Catheter 2.0 is complete, with only final certification needed for market launch. 7. Imricor aims for a commercial launch of the new MDR-compliant Advantage-MR system in Q1 2025, earlier than previously projected. 8. Imricor is developing MRI-compatible devices for cardiac ablations, aiming to improve treatment outcomes for arrhythmias compared to traditional X-ray methods.

🦷 Navigating the complexities of 510(k) submissions for dental bone graft devices? Dive into the latest insights from NAMSA's blog, authored by Gaëlle Clermont, PharmD, PhD. Uncover the FDA's recent draft guidance and its impact on preclinical studies. 🔬 From selecting the right preclinical model to understanding study design nuances, this post is a must-read for manufacturers aiming to meet Class II device requirements with precision. 👉 Stay ahead in the dental device field with NAMSA's expertise. Read the full blog here: https://lnkd.in/g3-cSmyW #NAMSAKnows #PreclinicalStudies #DentalDevices #FDA #510kSubmission #RegulatoryAffairs

1st revision of the guidance MDCG 2019-07 on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) regarding the ‘person responsible for regulatory compliance’ (PRRC) The Medical Device Coordination Group (MDCG) has made several additions throughout the MDCG 2019-07 guidance, including on the qualifications, professional experience, roles, and responsibilities of the PRRC, as well as references to ‘in vitro diagnostic medical devices’. #MDCG #MDR #IVDR #PRRC

LENSAR Reports Second Quarter 2024 Results and Provides Business Update August 08, 2024 17 New ALLY ® Adaptive Cataract Treatment Systems placed in 2Q 2024; highest number of placements since launch Received Medical Device Regulation (MDR) certification (CE Mark) and Taiwan FDA approval granted for commercial distribution of ALLY; First EU and Southeast Asia systems shipped Continued robust worldwide procedure growth; 2Q 2024 procedure volumes increased 19% over 2Q 2023 Installed system base grew 16% over 2Q 2023 ORLANDO, Fla.--(BUSINESS WIRE)-- LENSAR ® , Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”), a global medical technology company focused on advanced laser solutions for the treatment of cataracts, today announced financial results for the quarter ended June 30, 2024 and provided an update on key operational initiatives. https://lnkd.in/ednHtF37

New EC guidance to help in classifying IVD devices An updated guidance has been released by the Medical Device Coordination Group of the European Commission outlining the classification categories for in vitro diagnostic devices before being marketed under the IVD Regulation. Diagnostic devices are classified under the classes A, B, C and D based on the inherent risk and intended purpose of the devices. https://lnkd.in/evFYnd4a

MDCG 2024-11 Guidance Document This document provides crucial guidance for the medical device industry, clarifying qualification under the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). It outlines how products qualify as IVDs or their accessories, distinguishing between IVDR and the Medical Device Regulation (MDR). Manufacturers can benefit from practical examples and insights to avoid regulatory pitfalls and ensure compliance in product development and quality assurance processes. #MDCG #IVDR #MedicalDevices #RegulatoryCompliance #Guidance

A little teaser of what I have been working on for the last 2,5 years