ECM - Medical Devices (Ente Certificazione Macchine)’s Post

📑 Update! - Joint Implementation and Preparedness Plan for IVDR: Orchestrating Seamless Execution of the In Vitro Diagnostic Regulations in the European Union! It provides guidance on various aspects of the IVDR, including: ✔ certification, ✔ performance studies, ✔ and post-market surveillance. ◾ One interesting aspect of this document is its focus on ensuring a smooth transition to the new regulatory requirements and the coordination of efforts among various stakeholders to achieve this goal. ◾ It provides valuable insights into the implementation of the IVDR and the steps that need to be taken to ensure compliance with the new regulatory requirements. ◾ The document also emphasizes the need for transparency and common understanding of the requirements to facilitate the routine operation of hospital laboratories and the response to health crises. 👇 Check it out now! 🔗 Link: https://lnkd.in/eD3YBmiv #IVDRImplementation #MedicalDevices #EURegulations #HealthcareCompliance #IVDRCertification #PerformanceStudies #PostMarketSurveillance #RegulatoryCompliance #HealthTech #EUHealthcare

The International Association of Medical Regulatory Authorities (IAMRA) and the World Health Organization have signed a milestone MoU, paving the way for enhanced global health professional #regulation. This collaboration aims to bridge evidence gaps, bolster medical regulation capacity, and improve #healthcare quality worldwide, particularly in low and middle-income countries. Learn more about what’s ahead for healthcare standards: https://lnkd.in/g6natirR #IAMRA #WHO #Regulatory #GovTech #RegTech

Check out Duke-Margolis researchers latest white paper! ⭐ Duke-Margolis researchers examine the use of real-world data and real-world evidence in accelerated approvals and coverage decisions for medical products, and offer policy considerations. In particular, the authors explore real-world endpoint selection, generalizability of evidence, approaches for registries and #data repositories, point-of-care trials, external control arms, and private payer considerations in the context of leveraging RWD sources. Read more here: https://duke.is/9/6kkh Duke-Margolis Institute for Health Policy #healthpolicy #rwe #clinicaltrials #rwd #realworldevidence #medicalaffairs #marketaccess #access #patientjourney #patientoutcomes #fda FDA #CMS #heor #safety #clinicaldevelopment #coveragedetermination #reimbursement #pricing #registries #rarediseases

Last week the European Council announced the adoption of a proposal of the European Commission. It is set to extend the deadlines for some IVDs and enable a gradual rollout of the #EUDAMED. Additionally, manufacturers are required to inform relevant authorities, health institutions, healthcare professionals, and economic operators to whom they supply devices about potential shortages. The new #IVD deadlines look as follows: ➡ 31 December 2027 for Class D ➡ 31 December 2028 for Class C ➡ 31 December 2029 for Class B & A sterile With EUDAMED’s gradual rollout, it is expected that the use of the first module, which most likely will be the actor´s module, will be mandatory in late 2025. Use of the single modules will become mandatory after they have been declared fully functional and have been audited. Specific dates have not been published. This means that manufacturers and other EUDAMED users will have to finish their preparations for the use of #MDR’s databases much earlier than anticipated. To find out more about how to prepare you can read our updated article: https://lnkd.in/eN5jwgAE

The European Commission launched a public consultation on the cooperation with the European Medicines Agency under the Health Technology Assessment (HTA) Regulation. The proposed Implementing Act includes measures on: 📍Information-sharing 📍Joint clinical assessment/scientific consultations for devices and drugs 📍Patient identification and expert involvement in joint assessments 📍The protection of confidential information The public consultation will end on 24 July 2024 The Act is the third of six Implementing Acts undergoing public reviews > https://hubs.li/Q02DRtS-0 #HealthTech #RegulatoryFramework

The European Commission launched a public consultation on the cooperation with the European Medicines Agency under the Health Technology Assessment (HTA) Regulation. The proposed Implementing Act includes measures on: 📍Information-sharing 📍Joint clinical assessment/scientific consultations for devices and drugs 📍Patient identification and expert involvement in joint assessments 📍The protection of confidential information The public consultation will end on 24 July 2024 The Act is the third of six Implementing Acts undergoing public reviews > https://hubs.li/Q02DRlmV0 #HealthTech #RegulatoryFramework

📢 A NEW WEBINAR ABOUT CLINICAL EVALUATION 🌟 Join us to our next webinar on what is the role played by the PRRC in Clinical Evaluation presented by Helene Quie , founder & CEO of QMED Consulting on May 7th, at 5.00 pm CET. Clinical Evaluation is a mandatory part by the regulations for all devices, and it is a part of the technical documentation. To know more about the role played by the PRRC in Clinical Evaluation, don’t miss this webinar. The webinar is dedicated for members only. To register go to your member space, or click here: https://lnkd.in/d6rbVVFb We look forward to seeing you. #MDR  #IVDR #PRRC  #medicaldevice  #regulation #clinicalevaluation #clinicaldata  #regulatoryaffairs  #quality  #europe

🇬🇧 Updated 𝗠𝗛𝗥𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗜𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀, April 2024 Edition. 📝 This guide includes specific protocols for Northern Ireland due to the Northern Ireland Protocol. What’s Inside: ✔ Detailed procedures for notifying MHRA of clinical investigations. ✔ Criteria to determine if clinical investigations are necessary. ✔ Regulatory differences for conducting studies in Great Britain vs. Northern Ireland. ✔ Essential information on amendments, reporting adverse events, and final reporting. ◾ Understand when and how to conduct clinical investigations under the current UK and EU regulations and gain insights on the special considerations for devices involving higher risk categories. 🔗 For more detailed insights, click here to access the full guidance: https://lnkd.in/eVggGNqv #MedicalDevices #ClinicalInvestigations #MHRA #HealthcareInnovation #Brexit #UKRP #MDSS #MDR #IVDR

📢 Important update for EU Health Institutions! Starting May 26, 2024, almost all requirements for in-house devices under Article 5(5) of Regulation (EU) 2017/746 (IVDR) will be enforced. This is a major milestone for health institutions manufacturing in-house IVDs, exempt from CE-marking if used solely within the institution and compliant with Article 5(5). Article 5(5) is essential for all EU health institution developing in-house devices. Stay informed and ensure your lab meets the new standards! Learn more via our blog and IVD newsletter: 👉 https://lnkd.in/eBVa72ck 👉 https://lnkd.in/ebUm3kVw #IVDR #InHouseDevices #ISO15189 #MedicalLaboratories #QualityCompliance

A must-read paper for those interested in clinical studies and trials. For example, did you know that the Clinical Trials Regulation (CTR) has retained the definition of “clinical study” as it was in the CTD, but refined the definition of “clinical trial” as a subset of a clinical study. Also, the CTR defines a "non-interventional clinical trial" as “a clinical study other than clinical trial.” The entire White Paper is available at our Website: https://lnkd.in/ePFDuHik