MedBoard

🎉 Happy New Year from MedBoard 🎉 As we step into 2025, we want to take a moment to celebrate and thank our #community, which has just reached 20,000 followers! We wish all of you the very best for the year ahead. Your trust, engagement, and support inspire us every day to continue growing and fulfilling our mission: making trusted information accessible and processes faster for #Regulatory, #Clinical, and #Market professionals in the #MedTech, #Pharma, and #LifeSciences industries. MedBoard is ready for #2025, with exciting new Developments, Databases, Software Products, Intelligence Tools, Events, Content, and so much more in store! 🚀 Are you ready to start 2025 with MedBoard? Start transforming your productivity from here! Visit our website to request a free demo www.medboard.com #HappyNewYear #MedBoard #20KFollowers #ThankYou #MedTech #Pharma #LifeSciences #Regulatory #RegulatoryIntelligence #Compliance #SystematicReviews #RIMS #ClinicalResearch

Switzerland News!! (Obligations for Economic Operators in Switzerland) Swissmedic has announced an updated "Information Sheet titled Obligations for Economic Operators CH" reflecting the latest changes following the amendment to the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). This document describes the obligations and transitional provisions applicable to economic operators established in Switzerland and to devices that are made available on the market in Switzerland. This update is a direct result of the amendment to the IvDO, which introduces extended transitional periods and more time for healthcare institutions to meet compliance requirements for in-house products. The new notification obligation according to Article 10a EU-MDR and EU-IVDR, under which the manufacturer must provide notification of interruption or discontinuation of the supply of certain medical devices is not part of this revision of the Swiss ordinances. In the absence of a Swiss-EU Mutual Recognition Agreement (MRA), Switzerland implemented measures in 2021 to mitigate the impact of not accessing the EU database (Eudamed) and lacking market monitoring cooperation. These measures include: •Appointing an authorized representative ("CH-REP") •Registering economic operators with Swissmedic •Reporting serious incidents to Swissmedic •Recognizing EU certificates of conformity in Switzerland For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevice #medicaldevices #surveillance #clinicaltrials #automation #regulatoryintelligence #fda #medtech #ivdo #mdr #ivdr

UK MHRA News!! (Pharmacovigilance) The MHRA has today announced the publication of the updated document, "Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority." This guidance describes the aspects of the EU guidance on good pharmacovigilance practices (GVP) that no longer apply to the MHRA and UK MAHs, or are to be read subject to modification. This update, effective from 1 January 2025, reflects legislative changes introduced under the Windsor Framework and updates to UK pharmacovigilance practices. The document outlines significant changes to align with EU GVP updates, while also specifying modifications for UK-specific applications. This document is intended to be read in conjunction with the GVP modules, product- or population-specific chapters and annexes. This document references the version of the Commission’s GVP guidance that applied at the end of the transition period and future revisions and development of the GVP shall be duly considered by the licensing authority For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard.   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medtech #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #mhra #ema #gvp

US FDA News!! (Clinical Investigations) The US FDA has released the draft guidance, "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices. This draft guidance aims to help sponsors, investigators, and institutional review boards (IRBs) define, identify, and report protocol deviations consistently, ensuring the reliability of clinical study data and the safety of participants. This guidance includes the following: • Definitions for protocol deviations and important protocol deviations • Recommendations on the types of protocol deviations that sponsors should report to FDA in clinical study reports for drugs and devices • Recommendations on the types of protocol deviations that investigators should report to sponsors and to IRBs • Recommendations for IRBs in their evaluation of protocol deviations For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medicaldevice #medicaldevices #surveillance #clinicaltrials #automation #regulatoryintelligence #biologics #fda #medtech #pharma #irb

🌟 As 2024 comes to an end, the MedBoard team wants to say THANK YOU! 🌟 We are incredibly grateful to all our customers, partners, and supporters for this amazing year.  Your trust, collaboration, and support have been invaluable to our achievements in 2024. A huge thank you to our growing LinkedIn community, now nearing 20,000 followers!  We’re honored to share information and valuable insights with you every day, keeping everyone up-to-date. This holiday season, we hope you find time to pause, celebrate, and recharge for the opportunities the New Year will bring. At MedBoard, we continue growing and focusing on our mission, of making trusted information accessible and processes faster for all #Regulatory, #Clinical, and #Market #Professionals in the #MedTech, #Pharma, and #LifeSciences industry. We look forward to 2025, with a lot of news and developments in pipeline: New Databases, New Software Products, New Intelligence Tools, and many more! Wishing you all a joyful holiday season and a successful year ahead. See you in 2025 🎉 #MedBoard #ThankYou #HolidaySeason #Gratitude #NewYear2025 #2025 #MedTech #Pharma #LifeSciences #RegulatoryIntelligence #Compliance #ClinicalResearch #LiteratureReviews #RIMS #DataManagement

TGA News!! (Medical Devices Audit Framework) The Therapeutic Goods Administration (TGA) has opened a consultation on two draft guidance documents as part of its new risk-based application audit framework for medical devices. 𝐒𝐞𝐥𝐞𝐜𝐭𝐢𝐨𝐧 𝐂𝐫𝐢𝐭𝐞𝐫𝐢𝐚 𝐟𝐨𝐫 𝐍𝐨𝐧-𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐀𝐮𝐝𝐢𝐭𝐬: This guidance document outlines and clarifies the selection criteria that influence when we select medical device applications for a non-mandatory application audit, including the rationale for the proposed criteria. 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐀𝐮𝐝𝐢𝐭𝐬: 𝐂𝐚𝐬𝐞 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐏𝐫𝐨𝐜𝐞𝐬𝐬: This guidance document outlines the case management model that will be used throughout the life cycle of an application audit. It details the process, timeframes, and the role of the TGA case manager. The deadline for feedback submission for both documents is 17 February 2025. Link: https://lnkd.in/eGCqc2Cs For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #tga

GHWP News!! (SaMD) The Global Harmonization Working Party (GHWP) Work Group 3 has released its final white paper titled “Software as a Medical Device (SaMD) Pre-Market Submission Requirements – Comparison of Requirements from Key Jurisdictions”. This document provides a comprehensive comparison of SaMD regulatory pre-market submission requirements across leading jurisdictions. This document covers jurisdiction-specific requirement summaries including Japan (PMDA), Australia (TGA), China (NMPA), South Korea (MFDS), and Singapore (HSA). It covers software lifecycle requirements such as risk categorization, software validation, and traceability analysis. The document summarises the shared and unique requirements between jurisdictions including device hazard analysis, Unique Device Identification (UDI), and cybersecurity considerations. Following the GHWP 28th Annual Meeting and after the receipt of comments from members and the review by the GHWP leadership other documents that have been endorsed include: • White Paper on Overview of Quality Management System Requirements in GHWP member county or region against ISO 13485:2016: https://lnkd.in/eBSrqYxU • Change Management to Registered Medical Devices: https://lnkd.in/emwvgruV • Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative: https://lnkd.in/ejNwVVTT • Creation and Placement of Unique Device Identifier: https://lnkd.in/emetJNba • Guidance Document for Medical Device Organizations Product Localisation for Manufacturing and Importation: https://lnkd.in/etkuahMT For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard.   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #ghwp #tga #pmda #samd

UK MHRA News!! (Post-market Surveillance (PMS)) Today (20- December), the UK has published a new Statutory Instrument "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024" The Draft Statutory Instrument published in October 2024 has now been made. These regulations enhance post-market surveillance systems, clarify reporting obligations, and strengthen manufacturers' accountability for devices placed on the market in Great Britain. Key Updates: • Updates definitions that will apply for the purposes of post-market surveillance (PMS). • Manufacturers must establish a post-market surveillance system, which should be based on a PMS plan. • PMS Reports (PMSR) required for low-risk devices and updated every three years. • Periodic Safety Update Reports (PSURs) required for medium and high-risk devices (updated every two years or annually for high-risk devices) • Manufacturers must retain PMS documentation for at least 10 years after the last device is placed on the market (15 years for implantable devices). The PMS Regulations come into force 6 months from the day the regulations were made. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #mhra #fsca

EU AI News!! (General-Purpose AI Code of Practice – Second Draft) The EU has published the "Second Draft General-Purpose AI Code of Practice," a guiding document for providers of general-purpose AI models to demonstrate compliance with the AI Act. This draft builds upon feedback received on the first draft, released in November 2024, and was developed with input from over 1,000 stakeholders, including Member State representatives and international observers. The Code is a guiding document for providers of general-purpose AI models in demonstrating compliance with the AI Act along the full life cycle of the models. The second draft builds upon previous work while aiming to provide a “future-proof” Code; it will be particularly relevant for models which will be released after 2 August 2025 when the new rules on general-purpose AI models start to apply. Feedback is invited by 15 January 2025. The third draft is expected by 17 February 2025. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medtech #surveillance #regulatoryintelligence #ai #aiact #risk #artificialIntelligence

EU MDR/IVDR News!! (Availability Study – 2nd Survey) The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - via its European Health and Digital Executive Agency (HaDEA) - commissioned a “Study supporting the monitoring of the availability of medical devices on the EU market” to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG), in collaboration with Areté and Civic Consulting. The survey is part of a 36-month project that started in December 2022. This is already the second survey round with economic operators in this study. The first survey round took place from November 2023 to January 2024. The question set in this survey is very similar to the question set in the first survey round to allow for comparability of the results to some extent. Survey deadline: 28 February 2025 (23:59 CET) Survey Link: https://lnkd.in/deFicWdS For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #eumdr #fda #medicaldevice #medicaldevices #surveillance #ivd #eurl #mdcg #regulatoryintelligence