Ella Sheiman’s Post

Do you use the IMDRF document “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”? If so, AAMI wants to hear from you! ISO Technical Committee 210, which works on quality management related to medical devices, is looking for feedback from regulatory professionals, academics, and industry insiders – these survey answers will be used by the Technical Committee to guide their future work. What’s in the survey? The ten-minute questionnaire looks at:  - Your familiarity with Essential Principles.  - Challenges associated with using the document.  - Other resources you find useful. #medicaldevices #IMDRF #MedTech https://lnkd.in/e5ysGtr6 

26 April 2024 Final Document IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. Scope: The purpose of this IMDRF guidance is to provide harmonized Essential Principles that should be fulfilled in the design and manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended. The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to Regulatory Authorities. Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies (CABs), industry, and other stakeholders, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of RAs to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry #wyrobymedyczne #medicaldevices #mdr #ivdr #medtech #conformityassessment

È stato realizzato il documento Principles of Labeling for Medical Devices and IVD Medical Devices del 26 aprile 2024. This document applies to all medical devices, including IVD medical devices, and is intended to specify the general content and format of medical device and IVD medical device labeling in paper or electronic format. This document provides general labeling principles, including specific sections on the label, instructions for use, and information intended for the patient. The requirements of any relevant medical device or IVD medical device-specific standards should also be considered. While this document includes general labeling principles, it does not include sections that address other possible elements of labeling. Advertising and promotional materials may be considered elements of labeling by some RAs having jurisdiction, but they are outside the scope of this document. Individual jurisdictions may have their own regulations or requirements regarding other labeling elements or advertising and promotional materials. Source: https://lnkd.in/e4d4AuMh #IMDRF #labelling #MD #IVD #regulatoryaffairs #qualityaffairs #vlfconsulting

#Laboratory #Diagnostics # USA - FDA announces that it aims to amend its regulations to make explicit that IVDs always fall under FD&C Act and FDA including laboratory developed tests (LTDs) to increase safety and effectiveness after it found concerns with a number of LTDs. Comments period was closed in 12-04-2023 and FDA about to draft final rule. Due to phase-out of FDA's general discretion approach for LTDs, a timely staggered transition will occur for MDR, registration listing, labeling, QS, PMA and 510k of LTDs in question. https://lnkd.in/ds_2SjDy

📢 May 6th, 2024: FDA's Final LDT Rule is Now Official! ⏱ 🔗 https://lnkd.in/dCDzvKhV 🔍 Key Implications for Life Science Tools and Diagnostic Companies: 🎯 Stricter Compliance Required: With the end of enforcement discretion, all in vitro diagnostic products (IVDs), including lab-produced, must now fully comply with federal regulations. This increased scrutiny impacts manufacturers supplying components for LDTs, necessitating elevated compliance efforts. 🔄 Innovation and Strategic Realignment: The regulatory changes demand that life science tools and diagnostic companies innovate and adapt their product portfolios to meet new, more stringent standards. The focus is now squarely on developing FDA-compliant products. 📈 Increased Demand for Compliant Products: The reclassification of LDTs as IVDs will significantly increased demand for FDA-compliant diagnostic tests and workflow components. Manufacturers need to ensure their products meet the enhanced quality and safety standards put forward in the FDA LDT rule. 🛡️ Quality & Clinical Excellence in the Forefront: Enhanced FDA oversight requires robust quality systems and a strong focus on clinical and medical affairs, ensuring products not only meet regulatory standards but also uphold the relevant safety and clinical effectiveness criteria. 🚀 Strategic Growth Opportunities: This new regulatory environment presents significant opportunities for market expansion. Companies are encouraged to capitalize on the increased demand for compliant diagnostic products, thereby enhancing their market presence and driving growth. #HealthcareInnovation #MedicalDevices #FDARegulations #LifeSciences #Diagnostics #Compliance #QualityAssurance #IndustryNews

#Regulatory #News: Principles of #Labeling for Medical Devices and IVD Medical Devices - #New #IMDRF #Document This document provides general labeling principles, including specific sections on the label, instructions for use, and information intended for the patient. General #Labeling #Principles for Medical Devices and IVD Medical Devices The primary purpose of labeling is to identify the medical device or IVD medical device and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other relevant persons. The medium, format, content, legibility, and location of the labeling should be appropriate to the particular medical device or IVD medical device, its intended purpose, and intended users to ensure safe and appropriate use. These considerations should include the following, although others may also be applicable: > user knowledge > user training > any special needs of the persons for whom the device is intended > the location and environment in which the device can be used. Labeling should be subject to #document (version) #control #principles. Required documents should be developed and evaluated using #risk #management principles (1) and #usability #engineering processes (2). #Reference: 1. ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices 2. IEC 62366-1:2015 Medical Devices - Part 1: Application of the Usability Engineering Process to Medical Devices https://lnkd.in/dSu8A9nU Document: IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2); from 26.April 2024 #IMDRF #MedicalDevices #Compliance

How has the FDA's amended regulations on LDTs impacted your business? Will you be scrapping projects to avoid the changes or bolstering your process to pass IVD regulations? The FDA is phasing out enforcement discretion for LDTs and making them explicitly follow the IVD review process. May 2025 - Meet medical device reporting and quality system regulations May 2026 - Compliance with registration, listing, labeling May 2027 - Full quality system regulation compliance November 2027 - FDA Premarket review for high risk IVDs offered as LDTs May 2028 - FDA premarket for moderate and low risk IVDs offered as LDTs Ruling: https://lnkd.in/gZkUfjRB FAQ: https://lnkd.in/gdBs8HZR

FDA published the LDT Rule on May 6th, making clear they have oversight over LDTs. The effective date for the Rule is July 5th with a staged four year implementation and some exemptions for certain types of LDTs. The IVD regulatory experts Kennon Daniels, Ph.D., Maham Ansari, MS, RAC, Jo-Ann Fabila Gonzales, Erica Sablan, Sherma Winston, MSc., RAC, and Alice Bailey at Precision for Medicine are here to help you understand and implement a regulatory strategy that takes into account the requirements and timeframe of the Rule. https://lnkd.in/dUXaiPvj

In case you haven't noticed yet, the FDA's Final Rule on Laboratory Developed Tests is posted and scheduled to take effect with publication next week (May 6). The rule will phase in medical device requirements to LDTs over a period of four years: beginning with reporting and complaint files in year 1, registration and listing in year 2, quality systems regulation in year 3, and premarket review in year 3.5 and after. https://lnkd.in/eAMH2__Q

The classification of #medicaldevices and in vitro diagnostic #IVD devices is an important regulatory aspect that varies between the United States and the European Union. Each regulatory body has its own system for classifying these devices based on the intended use and the risk associated with the use of the device, and the classification determines the level of #regulatory control and #requirements for approval. Software based devices (Software in Medical Device #SiMD and Software as Medical Device #SaMD, together, #SxMD) follow the same rules as other medical devices and IVDs in terms of classification. Here's a #guide comparing the #medicaldevice and IVD classification systems in the US and EU ➡https://lnkd.in/ezGRG258