Lena Weissenbacher’s Post

SWISSMEDIC NEWS: Exciting update on the swissdamed Actors module! The first module of the swissdamed medical devices database is set to go live in August 2024. Due to the EU MRA not being updated, Swissmedic lacks access to the European database EUDAMED3. Since May 26, 2021, Swiss economic operators must register with Swissmedic to secure a unique registration number (CHRN). On August 6, 2024, the Actors module will launch, revolutionizing the registration process for economic operators. Stay tuned for this significant change in practice! #Swissmedic #MedicalDevices #RegulatoryCompliance #HealthcareIndustry #CHRN #EconomicOperators #Innovation #HealthTech

🚀Swissmedic is about to go live with the actors module of their swissamed database on medical devices. Thanks for the update Stefano 👍🏼 #Swissmedic #swissamed #actors #devices #registration #marketaccess

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🌍 Subscribe to MDSS News & Views for all the latest updates on Medical Devices across Europe, Switzerland, the USA, the UK, and Australia! 🏥 Whether you're a manufacturer, healthcare professional, or industry enthusiast, our newsletter keeps you informed and prepared! 👉 Be the first to know about new regulations, industry breakthroughs, and essential insights. Don't miss out! 🔗 Check it out here: https://lnkd.in/eZEdY5vN

🚀 Swissdamed Actors Module Go-Live in August 2024 🚀 We're excited to announce that the first module of the Swissdamed medical devices database will go live on 6 August 2024! This marks a significant step towards enhancing the registration and monitoring of economic operators in Switzerland. 🔹 Background: Due to the lack of an updated MRA with the EU, Swissmedic does not have access to the EUDAMED3 database. Since 26 May 2021, Swiss economic operators (manufacturers, importers, and authorized representatives) have been required to register with Swissmedic to obtain a Swiss Single Registration Number (CHRN). 🔹 Key Changes: End of PDF Forms: Applications for registration and CHRN changes will be accepted as PDF forms only until 26 July 2024. New Registration Process: From 6 August 2024, the registration of economic operators will be exclusively through the swissdamed portal at https://hubs.ly/Q02H8PT60. Online Contact: The email inbox chrn@swissmedic.ch will be replaced by an online contact form. 🔹 For Already Registered Operators: Data for approximately 3,700 registered operators will be migrated to swissdamed. Registered operators will be informed by letter in early August and will need to verify their data once imported. 🔹 Device Registration: In June 2024, initial upload options for devices were tested by selected manufacturers and UDI agencies. The first sections of swissdamed for voluntary device registration are planned for 2025, with compulsory registration to follow. This initiative aims to improve transparency, provide comprehensive information about medical devices on the Swiss market, and maintain an overview of the available range of devices. Stay tuned for more updates and ensure you transition smoothly to the new system! #MedicalDevices #Swissdamed #Swissmedic #HealthcareInnovation #RegulatoryAffairs

🌟 Market Spotlight: Swissmedical Switzerland Medical Device Registration 🌟 Switzerland, with its nearly 9 million population, is renowned for its robust medical technology sector, bolstered by strong fundamentals and political stability. However, the Mutual Recognition Agreement (MRA) between the European Union and Switzerland has been impacted by the EU's new medical devices (MDR) and IVDs (IVDR) regulations. This change necessitates separate compliance for devices intended for the Swiss market through the Medical Devices Ordinance (MDO). 🔍 Meeting Swissmedic Requirements 🔍 Regulatory Authority: Pure Global can assist with Switzerland medical device registration, ensuring Swissmedic approval to sell in the Swiss market. Classification: The classification of medical devices in Switzerland follows the EU's system, based on the device's intended use and associated risk. This classification determines the specific registration and compliance requirements with Swissmedic. Key Requirements: Swiss Authorized Representative: Manufacturers outside of Switzerland must appoint a Swiss Authorized Representative (Swiss AR or CH REP) to act on their behalf. The Swiss AR ensures the manufacturer reports vigilance to Swissmedic. Pre-Market Registration: Ensure pre-market registration and compliance with the MDO, facilitated by the Swiss AR. Choosing Pure Global means seamless navigation through complex regulatory landscapes. Our expertise ensures your medical devices meet Swissmedic standards efficiently and effectively. Ready to enter the Swiss market with confidence? Contact Sales today! https://lnkd.in/d9Smgkqb #MedicalDevices #Regulation #Swissmedic #PureGlobal #MedTechInnovation #MarketSpotlight #Switzerland #IVDR #MDR

📢 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝗶𝗲𝘀 𝘀𝗽𝗲𝗮𝗸 𝗹𝗼𝘂𝗱𝗹𝘆 𝗮𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗳𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀! 🎯 A new Consensus Statement has just been published, outlining the next steps for the implementation of the European Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR). ✅ What does this mean for you? More safety for patients, greater clarity for companies, and a more innovative market. 🔎 Want to know more about the priorities and challenges identified? Read the document below. #medicaldevices #regulation #health #innovation #eudamed #infarmed #hma Medical Devices Regulatory — support unit Instituto Pedro Nunes Luiz de Pádua Queiroz Júnior Sandra Balseiro Ana Brito Celeste Oliveira Raquel Gomes Ana Catarina Silva Sílvia Antunes Natalia de Souza Lescura

Only 2 weeks to go until the Medical Technology Association of Australia (MTAA) MedTech Conference 2024 at the ICC, Sydney. As the premier event for the medical technology industry in Australia, the conference brings together thought leaders and key influencers from industry, government, and academia to explore the latest trends shaping MedTech. As a MTAA Industry Member, we’re thrilled to be sponsoring the Prescribed List clinical evidence session at this year's conference. Our Director, Sarah Griffin is also attending the conference and looks forward to connecting with attendees and colleagues. To find out more about the MedTech 2024 conference and to register, see the post below. #medtech #innovation #MTAA #healthcare #clinicalevidence #reimbursement #medicaldevices #marketaccess #medtechniqueconsulting

I’ll be attending the Medical Technology Association of Australia (MTAA) MedTech Conference 2024, happening in just 2 weeks at the ICC in Sydney! As Australia’s premier event for the medical technology sector, this conference will gather top innovators, key decision-makers from industry, government, and academia, to discuss the trends shaping the future of MedTech. I’m also thrilled to share that MedTechnique Consulting will be sponsoring the Prescribed List Clinical Evidence session, offering valuable insights into clinical compliance and the latest regulatory developments. Looking forward to connecting with industry peers. 🔗 Find out more about the MedTech Conference 2024 in the post below. #medtech #innovation #MTAA #healthcare #clinicalevidence #medicaldevices #marketaccess #medtechniqueconsulting

🌍📈 Expanding Horizons for Medical Device Manufacturers! 🏥🔍 At Patient Guard Europe, we understand the complexities and regulatory hurdles that come with gaining market access in the EU for medical device manufacturers based outside of Europe. That's why we're here to make the journey smoother and more efficient! As an EU Authorized Representative based in Germany, Patient Guard Europe has been instrumental in helping a growing list of manufacturers navigate the stringent requirements and achieve successful entry into the European market. Our dedicated team ensures compliance with all necessary regulations, providing the expertise and support needed for your products to thrive in the EU. 🔹 Why Partner with Patient Guard Europe? Expert Knowledge: Our team stays updated with the latest EU regulations and standards. Streamlined Processes: We handle the complexities of market entry, allowing you to focus on innovation. Reliable Representation: Acting as your EU Authorized Representative, we ensure your compliance and support your brand within the European market. Join the list of satisfied manufacturers who have trusted Patient Guard Europe to expand their reach and bring innovative medical devices to the EU. Visit us at patientguard.com to find out more. #MedicalDevices #EUCompliance #MarketAccess #PatientGuardEurope #HealthcareInnovation #GlobalExpansion