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🚑 New Video Alert! 🎥 This #februarynewsletter 2024 includes the following points: ✅ Medical Devices Regulations across all the Countries  ✅ Cosmetic Product Updates. ✅ New MDCG Guidelines ✅ List of Updated ISO Standards for February 2024 Whether you're a professional in the field, a student, or someone curious about the world of medical devices, this video is your gateway to understanding medical devices. Boost your knowledge and stay ahead of the curve! https://lnkd.in/gXfQEeQZ 💡 Don't forget to subscribe for more in-depth insights and leave a comment on what you'd like us to cover next. #OMCMedical #medicaldevices #healthcare #regulatoryaffairs #regulatorycompliance #globalinnovation #cosmetics #eumdr #isostandards #februarynewsletter

💡 New Regulatory Update for Medical Devices in Portugal 🇵🇹 On April 5, 2024, Portugal took a significant step in aligning with European Union standards by officially publishing the Decree-Law no. 29/2024. This important legislation enforces Regulation (EU) 2017/745 on medical devices and sets the stage for further regulatory enhancements in the sector. 📅 Key Date: The provisions of this new legislation will come into effect on July 4, 2024. 🔍 What This Means: While maintaining certain interim measures from previous legislation, this Decree-Law solidifies Portugal's commitment to aligning with EU standards, ensuring the safety and effectiveness of medical devices within its healthcare system. #medicaldevices #HealthcareRegulation #Portugal #MDR #medicaldeviceregulation #Compliance #medxteam 

This week, we are featuring a capability alert for Trajan Scientific and Medical - Trajan's microsampling devices CE-IVD registration Trajan Scientific and Medical expands its person-centric healthcare solutions with IVDR regulatory compliance, CE-IVD registration of its Mitra® and hemaPEN® microsampling solutions as medical devices in Europe and the United Kingdom. These remote devices can be used at home and in #healthcare settings & #clinicaltrials throughout #EU & #UK. Nearly 50% of trials are not completed due to insufficient enrollment. What if they didn't have to travel to the study site or miss any time from work or school to attend clinic appointments? If submitting blood samples for a study was as simple as a quick finger-stick collection at home and a short walk to the neighborhood mailbox to send the samples to the lab, more people might participate in trials and find it easier to complete them. Want to learn more? Register for ClinEco and connect with Trajan Scientific and Medical today! Corinna Rockenbach Christa Nuber #CapabilityAlert #ClinicalResearch #Healthcare

🌐 Latest News! 📣 The Medicines and Healthcare products Regulatory Agency has just unveiled its roadmap for the new UK regulatory framework - a significant step towards creating a more predictable and harmonised environment for the healthcare industry. 🗓️ By 2025, this plan will introduce new Statutory Instruments, focus groups, and guidance, promoting international harmonisation with a patient-centered approach. 🚀 We have consistently emphasised the need for such a roadmap, and our recent business survey reinforced the impact of regulatory uncertainty on innovation and investment in the UK. 🤝 Collaboration has been key! ABHI has actively engaged with MHRA, the Office for Life Sciences, and the DHSC, alongside other national and international stakeholders. 💡 We believe the UK has a unique opportunity to foster innovation and growth in the healthcare sector, maintaining safety while empowering local businesses to expand globally. As ever, we appreciate the support and input of members in help us contribute to this work. 📌 We look forward to working with the MHRA, and maintaining our engagement through international fora, such as the International Medical Device Regulators Forum and the Global Medical Technology Alliance, to ensure successful implementation. Stay tuned for updates throughout the year! Phil Brown Steve Lee #HealthcareInnovation #UKRegulations #MHRA #UKHealthTech

🔥Regulatory News from Denmark: *Did you know that companies dealing with products without a medical purpose must be registered?* Subscribe now to read the full story: https://lnkd.in/dUiFxgap #medicaldevices #dispositivosmedicos #dispositifsmedicaux #medizinprodukte #regulatoryaffairs #dispositivimedici

Several Ministers of Health recently called for early mandatory availability of the European Medical Devices Database (EUDAMED). Six industry associations, including AESGP, highlight important preconditions that are needed before any modules of EUDAMED would be made mandatory: 1. The modules are fully developed, tested, audited and ready for practical implementation. 2. EUDAMED enables the most efficient use of Notified Body and Manufacturer resources. 3. Realistic and reliable implementation and transition timelines are provided. 4. Redundancy in National Databases is eliminated. Read our Joint Open Letter: https://lnkd.in/eJyfV6ek AESGP, COCIR, European Hearing Instrument Manufacturers Association (EHIMA), Euromcontact - The voice of the manufacturers of contact lens and lens care products, MedTech Europe #EUDAMED

The 2nd Annual Medical Devices Regulations & Safety Online Conference will be held on 5-6 December, virtually, bringing together industry leaders, regulatory experts, and healthcare professionals to discuss the latest developments and challenges in medical device regulations and safety. The virtual event will feature keynote addresses, panel discussions, and breakout sessions focused on critical topics such as compliance with international standards, post-market surveillance, and innovations in safety technologies. Attendees will have the opportunity to gain insights from regulators, network with peers, and explore solutions to enhance patient safety and product efficacy. Esteemed speakers will present from leading companies such as TÜV SÜD, Medtronic, ZimVie, and others. To find out more, please visit: https://lnkd.in/gVenDBWY VNA International #medicaldevices #healthcare #regulatoryaffairs #events #industryevents #healthcareprofessionals

It’s good to see an increased capacity for approving medical devices in the UK market, in what has been a torrid time for some manufacturers. It’s so important for both our healthcare system and the economy, that innovation continues to thrive with less blockers to taking safe, life-saving products to market. What else can be done to support Medical Device manufacturers in 2023?

📢 Big news! 🌍 𝗠𝗛𝗥𝗔 𝗔𝗻𝗻𝗼𝘂𝗻𝗰𝗲𝘀 𝗮 𝗡𝗲𝘄 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝗳𝗼𝗿 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗥𝗲𝗰𝗼𝗴𝗻𝗶𝘁𝗶𝗼𝗻... ◾ The MHRA proposes recognizing medical device approvals from 𝗔𝘂𝘀𝘁𝗿𝗮𝗹𝗶𝗮, 𝗖𝗮𝗻𝗮𝗱𝗮, 𝘁𝗵𝗲 𝗘𝗨, 𝗮𝗻𝗱 𝘁𝗵𝗲 𝗨𝗦𝗔, streamlining access to innovative MedTech in the UK. 🗣 Dr. Laura Squire: "𝘛𝘩𝘪𝘴 𝘴𝘵𝘦𝘱 𝘱𝘳𝘪𝘰𝘳𝘪𝘵𝘪𝘻𝘦𝘴 𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘴𝘢𝘧𝘦𝘵𝘺 𝘢𝘯𝘥 𝘦𝘯𝘴𝘶𝘳𝘦𝘴 𝘵𝘩𝘦 𝘜𝘒 𝘳𝘦𝘮𝘢𝘪𝘯𝘴 𝘢 𝘵𝘰𝘱 𝘮𝘢𝘳𝘬𝘦𝘵 𝘧𝘰𝘳 𝘮𝘦𝘥𝘪𝘤𝘢𝘭 𝘵𝘦𝘤𝘩𝘯𝘰𝘭𝘰𝘨𝘺." 💬 What do you think about this move? Share your thoughts in the comments! 🔗 Read the full press release here: https://lnkd.in/eqhsb7ed #MedicalDevices #MHRA #MedTech #Innovation #PatientSafety #Healthcare #MDSS #UKRP #NEWS

Several Ministers of Health recently called for EUDAMED (the EU medical devices database) to be made mandatory. Read the open letter from 6 EU medtech trade associations - AESGP, COCIR, EHIMA, EUROM, EUROMCONTACT and MedTech Europe - where we highlight important preconditions that are needed before any modules become mandatory:  1. The modules are fully developed, tested, audited and ready for practical implementation. 2. EUDAMED enables the most efficient use of Notified Body and Manufacturer resources. 3. Realistic and reliable implementation and transition timelines are provided. 4. Redundancy in National Databases is eliminated. Here is a link to the joint open letter: https://lnkd.in/ecVExmDX #eudamed #mte #ivdr #mdr