Medical Devices Regulatory — support unit’s Post

📣📢The Regulation that MD/IVD manufacturers have been waiting for! On July 9th, the Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices has been published in the OJEU. The aim of the regulation is to mitigate shortages of critical medical devices. The new regulation amends the current legislation on medical devices, including in vitro diagnostic medical devices (IVDs), by: ▪️ Enabling a gradual roll-out of EUDAMED, the new electronic database – new timeline also published! Check it out at the following link: [Link] ▪️ Requiring manufacturers to inform stakeholders about potential shortages or discontinuation of supply in the market of critical medical devices and IVDs 6 months in advance (New article 10a) – Applicable from 10 January 2025, meaning it is now time for manufacturers to start preparing. ▪️ Further extending the transition period for IVDDs legacy devices. Verify the conditions for the extension: 👉If there are no significant changes in design or intended purpose; 👉 If the devices do not pose an unacceptable risk to patients; 👉 If the Manufacturer’s QMS is implemented by 25 May 2025; 👉If the Manufacturer has first submitted a formal application to a Notified Body; 👉 If the Manufacturer has finally signed a written agreement with a Notified Body. 📧 Owlpharma is here to support with the new regulation and help your medical device meet compliance. #Owlpharma #MedicalDevices #Regulation #News #EUDAMED #OJEU #IVDS

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

📢 Important Update for Medical Device and IVD Manufacturers The MDCG has released Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices. This guidance provides essential instructions and a standardized form for manufacturers to notify authorities about supply interruptions or discontinuations. It’s a crucial step towards ensuring transparency and maintaining patient safety in the EU medical device landscape. 📄 We have attached the official document to this post for your reference. Let’s work together to stay informed and compliant with the evolving regulatory requirements. #MedicalDevices #IVD #MDCG #Regulations #Compliance

The EU Commission has adopted new regulations for in vitro diagnostic medical devices (IVDR), extending transitional periods for market access. Manufacturers must notify authorities of any supply shortages. The EUDAMED database accelerated rollout begins in Q4 2025. Need support navigating these changes? Contact our Senior Advisor Mette Hassan for expert guidance! #IVDR #MedicalDevices #EUCompliance #EUDAMED #RegulatoryUpdates #Mericon

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

🌐 Global Harmonization in 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗮𝗯𝗲𝗹𝗶𝗻𝗴 IMDRF DOCUMENT: Principles of Labeling for Medical Devices and IVD Medical Devices - 26 April 2024 (Edition 2) SCOPE 🔎 this document applies to all medical devices, including IVDs, and provides comprehensive guidelines for the content and format of medical device labeling, whether in paper or electronic format. PURPOSE 🎯 the primary goal of this document is to establish globally harmonized principles for medical device labeling, by providing guidance on label content, instructions for use and patient information. Its implementation is expected to benefit Regulatory Authorities, Conformity Assessment Bodies, industry stakeholders, and end-users, by establishing consistent labeling requirements across jurisdictions and reducing country-specific variations. 🩺 Stay tuned for more updates as we continue to prioritize global harmonization and safety in medical device labeling! Download the full document 📑 https://lnkd.in/dWkWERBF #MedicalDevices #IVD #RegulatoryHarmonization #IMDRF #MDR

TS Quality and Engineering is pleased to share the new IMDRF document on Principles of Labeling for Medical Devices and IVD Medical Devices, released on April 26, 2024. This document provides valuable guidance on the content and format of medical device labeling, including: - General labeling principles - Specific sections on the label - Instructions for use - Patient information While this document focuses on labeling principles, it's important to note that individual jurisdictions may have additional regulations or requirements for other labeling elements or advertising materials. Stay informed and ensure compliance with the latest regulatory guidance. Read the full document to learn more! #MedicalDevices #IVDDevices #LabelingGuidance #RegulatoryCompliance #TSQualityAndEngineering

For #medicaldevice manufacturers in the #EU. The Medical Device Coordination Group #MDCG has endorsed a new form under MDCG 2024-16 to address the reporting of interruptions or discontinuations in the supply of certain medical devices and in vitro diagnostic medical devices #IVDs. This form aligns with Article 10a of Regulation (EU) 2024/1860, which amends the EU Medical Devices and IVD Regulations. This form serves as a streamlined mechanism for manufacturers, authorized representatives, and other entities acting on behalf of manufacturers to notify National Competent Authorities (NCAs) of supply disruptions. It allows for reporting on individual devices or multiple devices of the same manufacturer affected by the same issue. The form includes sections for detailed device identification, reasons for supply interruptions (such as regulatory, supply chain, or manufacturing issues), and impact assessments. Manufacturers must provide information on critical aspects such as whether the devices are life-sustaining, intended for vulnerable populations, or have limited alternatives available. To mitigate the impact on patients, the form encourages manufacturers to explore redistribution of stocks, identify similar alternative products, or provide updates on inventory levels. This approach aims to ensure timely communication between stakeholders, enabling coordinated efforts to address disruptions and prioritize patient safety. Manufacturers are encouraged to familiarize themselves with the reporting process outlined in this form and adhere to the guidance to ensure compliance and effective collaboration with NCAs. Do you need support securing compliance and the best regulatory strategy for your medical devices and in vitro diagnostics IVDs? Reach out to us ☞ meetus@taoexcellence.ch #MDCG2024 #MedicalDevices #IVD #EURegulations #PatientSafety #HealthcareInnovation #RegulatoryCompliance #SupplyChainManagement #MedicalDeviceIndustry #HealthTech #MedTech #EUHealthcare #MedicalDeviceRegulation #HealthRegulation #regulatoryaffairs

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices #IMDRF #SafetyAndPerformance #MedicalDevices #IVD