Barcelona Health Hub’s Post

📢 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

💡Did you know? The European Commission has recently updated its standardization request for medical devices and in vitro diagnostic medical devices! 🌟 On May 27, 2024, the Commission issued a decision to amend its previous request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). This update aims to reflect the latest technical and scientific advancements in the field, ensuring that our medical standards remain cutting-edge and globally competitive. Key updates include:  🔹 Extending the deadline for the joint final report to June 30, 2028.  🔹 Updating and revising several harmonized standards to support the regulations (EU) 2017/745 and (EU) 2017/746.  🔹 Adjusting the scope to include new standardization projects and remove outdated ones.  🔹 Addressing resource limitations and delays in the standardization process. ➡️https://lnkd.in/dWCJng_W #medizinprodukte #medizinprodukteverordnung #medicaldevices #medicaldeviceregulation #Healthcare #MedTech #medxteam 

📢 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

At MedtecLIVE, Michael M. Kania discussed the current situation between manufacturers and notified bodies and the excessively long certification processes with Christian Johner from the Johner Institut GmbH, Harald Rentschler from mdc medical device certification GmbH and Andreas Purde from TÜV SÜD. The common consensus among the panelists was clear. The solutions must be digital and no longer rely on documents. Only in this way can processes run without friction and the capacities on both sides be used efficiently. #EUMDR #IVDR #MedicalDevices #MedTech #RegulatoryAffairs #Medizintechnik

MDR has a profound impact on pre-CE studies, as well as the use of real-world data (RWD) and real-world evidence (RWE) in medical device development and post-market surveillance. RWE is an increasingly hot topic in the field of medical devices. Where to look for RWD? How to use it during the entire MD life cycle to prove the performance and safety of medical devices? How to implement RWD in clinical trial design? You will find the answer to these and many other questions in my contribution at The 3rd Conference on Clinical Studies with Medical Devices and IVDs (CSMD2024). Come and join us! #CSMD2024 https://csmd2024.com/

The Swiss database on medical devices – https://swissdamed.ch has been live since August 6, 2024, and the deadline for validating the data of registered economic operators (EOs) is fast approaching—November 13, 2024. ⏳ There has been some confusion about the registration process and the applicable timelines, so let’s clarify. 💡 Swiss legislation takes a different approach from the MDR when it comes to EOs in the medical device sector. Actor registration is required for entities domiciled in Switzerland 🇨🇭, including Swiss manufacturers, Authorized Representatives, importers, and Swiss system and procedure pack producers (CH SPPP). These entities, upon registering their data with Swissmedic receive a CHRN (Swiss single registration number). They are also required to report any changes to the registered data within 7 days. Since October 18, 2022, this registration obligation has extended to entities in Liechtenstein 🇱🇮 due to the customs treaty with Switzerland. Prior to swissdamed, actor registration was managed through a manual process of notification forms and emails. 📧Over 3,000 actors registered with Swissmedic this way. Swissdamed now centralizes and simplifies the registration and surveillance of actors in the Swiss medical device market. Swissmedic has already transferred existing registrations into the system, so no new registrations from scratch are required for these actors. However, registered actors received a letter from Swissmedic with instructions on how to validate their data in swissdamed, which is essential for activating their accounts. ‼️ The deadline for validation is November 13, 2024—3 months from Swissmedic’s notification. The validation process is simple and quick, but failure to validate will result in deactivation by Swissmedic For more details, visit the Swissmedic website: https://lnkd.in/ek3AvRuz

Discover the insights from our Managing Director, Digital Health & Innovation, Alberta M.C. Spreafico, PhD, MBA, in EVERSANA’s article focused on the challenges faced by manufacturers of software as a medical device (SaMD) following the implementation of Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR). Alberta Spreafico, along with co-authors Gwilym Owen and Kory Dillman, sheds light on the loophole that allowed SaMD to be misclassified under the previous Medical Device Directive (#MDD) and the implications of this misclassification under the MDR. Learn more about the challenges and solutions in the article: https://lnkd.in/d4Jem7Bh #SaMD #MDR #HealthcareRegulation #DigitalHealth #Innovation Faruk Capan Roberto Ascione Abid Rahman Scott Snyder Rosario Curia Petteri Kolehmainen Anna Dina Bove Valeria Boccardo

The Medical Device and Diagnostic Innovation Cluster (MeDDIC), under the auspices of the South African Medical Research Council (SAMRC), is pleased to invite you to join us for the first Medical Devices Stakeholder Forum (MDSF) meeting for 2024. The MDSF is aimed at facilitating dialogue in the medical devices and diagnostics sector and will cover a wide range of topics ranging from Regulatory, Funding, Skills Development and Value chain(s). This is one of the tools we would like to re- introduce post the conclusion of the Medical Technology Masterplan to help achieve MeDDIC’s mission towards developing a vibrant, cohesive ecosystem in which stakeholders co-operate and collaborate to seamlessly design, develop, manufacture and commercialize medical devices with a significantly increased local content and thereby contributing to the sector and broader economic development.” The topics for the upcoming discussion will include but are not limited to challenges and opportunities in regulatory, reimbursement and procurement of medical devices and diagnostics. Please join us and share your experience and possible recommendations to help us build a more cohesive ecosystem. 

📣 Excited to share insights from the recent webinar on Understanding Medical Devices Regulation! 🩺 💡 Sandra Balseiro guided us through the essential steps of CE marking, while João Quintas explored technical and usability requirements under the MDR through insightful case studies. 🤝 In addition, we would like to thank Célia Ludovino and Ana Abreu for sharing valuable insights on the transition to and mastery of European Regulation 2017/745, in the real cases of companies BHL-Medical, Indústria de Produtos Hospitalares, Lda, and Kinetikos Health respectively. Health Cluster Portugal Patrícia Patrício Instituto Pedro Nunes #medicaldevices #MDR #IVDR #ivd #regulatoryaffairs #regulatorycompliance #startups #hcp #ipn #MDRu #usability #IEC62366 #ISO13485

🚀 Exciting News from Swissmedic! 🚀 We are thrilled to share that Swissmedic is making significant strides with the Swissdamed pilot test product registration. The first parts of Swissdamed will be available for voluntary registration of certain products in 2025. 📅 Key Dates to Remember: August 2024: Launch of the first Actor module for company and economic operator registration. 2025: Voluntary registration of certain medical devices, including IVDs. This initiative marks a pivotal step towards enhancing the transparency and regulation of medical devices in Switzerland. Stay tuned for more updates! 🔗 For more information, visit: Swissmedic Swissdamed https://lnkd.in/eUjAGcCa #MedicalDevices #Swissmedic #Swissdamed #RegulatoryAffairs #TSqualityAndEngineering