ASPHALION’s Post

EU MDR / IVDR News!! (Joint Scientific Consultations (JSC)) The European Commission has published a draft implementing regulation "laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices" The Draft Commission Implementing Regulation provides detailed procedural guidelines for joint scientific consultations under Regulation (EU) 2021/2282, for medical devices and in vitro diagnostic medical devices. This Regulation lays down detailed procedural rules for: • Procedures for health technology developers to submit consultation requests; • Setting of request periods for joint scientific consultations; • The coordination process involving external expert panels; • The management of personal data; • Involvement of patients and experts This draft act is open for feedback for 4 weeks, from 29 October 2024 - 26 November 2024. Link to initiative: https://lnkd.in/edvjg_j8 For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #eumdr #hta #jsc

During a House Health Subcommittee hearing, FDA leaders faced tough questions about delays in medical device approvals and missteps in regulatory processes. Lawmakers expressed concerns about the slow approval of innovative devices, regulatory burdens on laboratory-developed tests (LDTs), and the need for improved communication with applicants. They also discussed the importance of a third-party certification model for AI/ML-enabled devices and the FDA's efforts to streamline innovation through programs like the Breakthrough Devices Program. FDA officials acknowledged challenges and sought congressional support for needed reforms. https://lnkd.in/dWh8EvvC #healthcare #healthcareinnovation #healthcareit #healthcareai #ai #medicaldevices

EU MDR/IVDR News!! (Call for Evidence on Medical Devices and IVDs Evaluation) Today (12-December), the European Commission launched a Call for Evidence for the Evaluation of EU Rules on Medical Devices and In Vitro Diagnostics (MDR & IVDR). This targeted evaluation aims to assess the effectiveness, efficiency, and relevance of the regulations from 2017 to 2024 and is a key step towards improving the regulatory framework for medical devices in the EU. The Call for Evidence will run from 12 December 2024 - 21 March 2025. The consultation process will include the following actions. • A call for evidence for interested parties to provide feedback in any of the 24 official EU languages. • A 12-week questionnaire-based public consultation giving interested parties the possibility to contribute to the evaluation in any of the 24 official EU languages. • A set of targeted consultation activities tailored to particular stakeholder’s groups, including workshops. • Consultations of the Medical Device Coordination Group in order to complement the consultation process. • A stakeholder conference will take place during the evaluation to further complement the process. • Particular focus will be put on SMEs involvement and specific ways to further reach out to them are being explored. Link for feedback: https://lnkd.in/emHwpyxU For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #eumdr

For #medicaldevice manufacturers in the #EU. 🇪🇺 The Medical Device Coordination Group #MDCG has recently published its roadmap outlining upcoming guidance documents for both the #MDR (EU 2017/745) and #IVDR (EU 2017/746) regulations. This information is crucial for manufacturers, notified bodies, and other stakeholders navigating the evolving regulatory landscape. Key Areas of Focus 🔎 🔹 Notified Body Oversight: Updates to guidance on designation, notification, qualification of personnel, and more. 🔹 Standards: Continued development of guidance documents to support the use of harmonized standards. 🔹 Clinical Investigations and Evaluation: New Q&A documents, clinical investigation contingency approaches, and investigator's brochure guidance. 🔹 Post-Market Surveillance and Vigilance: Revisions to reporting forms, guidance on implementing vigilance requirements, and PSUR extension for IVDRs. 🔹 Market Surveillance: Guidance for custom-made and adaptable devices (coming in 2025). 🔹 Borderline & Classification: Minor revisions to existing guidance and an exploratory paper on specific product qualifications. 🔹 New Technologies: Addressing the legal status of app providers and the interplay between MDR/IVDR and AI. 🔹 Unique Device Identification (UDI): Guidance on Master UDI-DI. 🔹 In Vitro Diagnostic Medical Devices: Focus on common specifications, performance studies, safety reporting, borderline issues, and research use only devices. 🔹 Nomenclature: FAQs and tools for navigating the EMDN. 🔹 Other MDR Guidance: Addressing certificates under specific conditions, application of clinical evaluation to orphan devices, and "legacy devices“. This information empowers stakeholders to stay informed and prepare for upcoming regulatory changes. Are you a manufacturer of medical devices or in vitro diagnostics who needs support placing products on the #EuropeanMarket or the #Swissmarket? We provide hands-on regulatory guidance and the service to be your CH-REP. #MedicalDevices #Regulation #Guidance #medicaldeviceregulation #IVDs #regulatoryaffairs #regulatorycompliance #medtech #healthcare #healthtech #qualitymanagement #QMS #ArtificialIntelligence 

In the EU, clinical trials deploying medical devices and in vitro diagnostic devices navigate a complicated route to regulatory compliance. In the latest RF Quarterly we explain those requirements, the role of notified bodies and how these devices are classified. Read the article: https://ow.ly/iyq350UrFlz #regulatoryaffairs #regulatory #regulatorycompliance #regulatorysubmissions #clinicaltrials #EUCTR #EUClinicalTrialRegulation #MDR #IVD #europeanmedicinesagency

The MHRA has launched a consultation on proposed changes to pre-market regulations for medical devices, focusing on 4 key areas: UKCA Marking: They’re considering scrapping the physical UKCA marking in favour of improved device traceability through Unique Device Identification (UDI). How has UKCA impacted your product launches, and do you think it’s time to move away from it? International Reliance: This could speed up UK market access for devices approved by other regulators. Would this help accelerate innovation and market entry for your products? IVD Classification: The new risk-based classification for in vitro diagnostics, especially for Class B devices—how might this help market access? Assimilated EU Law: Extending some EU regulations to ensure a smoother transition to the new UK framework. Should we hold onto these laws or fully move to a UK-specific system? From the conversations I’ve had, many feel Brexit changes have slowed innovation. Is this review a step in the right direction? I’d love to hear your thoughts! Health Tech World article in comments #MHRAConsultation #MedTechRegulations #UKCAMarking #MedicalDevices #MedTechInnovation #RegulatoryAffairs #HealthcareTechnology #BrexitImpact #IVDDevices #PatientSafety

For #medicaldevice manufacturers in the #EU. 🇪🇺 As we approach the anticipated go-live of most #EUDAMED modules in 2025, MedTech Europe has published a position paper outlining the industry’s perspectives on achieving a seamless transition to the mandatory use of this essential European database for medical devices. EUDAMED serves as an infrastructure of the EU’s Medical Device Regulation #MDR and In Vitro Diagnostic Regulation #IVDR, and its successful implementation is critical for regulatory compliance, patient safety, and industry efficiency. MedTech Europe highlights the need to address usability challenges, provide adequate support for stakeholders, and establish clear, reliable timelines for the database’s final development phase. The paper emphasizes the importance of technical and regulatory measures to enhance accessibility, efficiency, and consistency. Industry readiness and the efficient use of resources will be central to ensuring a successful transition to EUDAMED’s mandatory use. Are you a manufacturer that needs support with the EUDAMED actor registration? We help you implement all the regulatory requirements for a fast market access. Contact us to save time ☞ meetus@taoexcellence.ch #regulatorycompliance #regulatoryaffairs #innovation #patientsafety #publichealth #healthcare #healthtech #MedicalDevices #MedTech #invitrodiagnostics #IVDs #database #datacollecting #notifiedbodies 

𝐂𝐎𝐌𝐄 𝐓𝐎 𝐃𝐈𝐒𝐂𝐎𝐕𝐄𝐑 𝐔𝐒 𝐈𝐍 𝐏𝐇𝐈𝐋𝐀𝐃𝐄𝐋𝐏𝐇𝐈𝐀!   At the beginning of this year Thema consolidated its presence in the United States with a dedicated society, THEMA CORP, located in 𝐏𝐡𝐢𝐥𝐚𝐝𝐞𝐥𝐩𝐡𝐢𝐚 at B+Labs c/o Cira Center, to provide 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐧𝐬𝐮𝐥𝐭𝐢𝐧𝐠 𝐬𝐞𝐫𝐯𝐢𝐜𝐞𝐬 to companies in the medical device, in vitro diagnostic medical device, and related regulated industries.   𝐓𝐇𝐄𝐌𝐀 𝐂𝐎𝐑𝐏 aims to help its clients achieve their marketing goals offering a reliable, competent and specialized regulatory support to market in U.S.A., Europe and worldwide through different services, such as:   ☑ 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜-𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐢𝐧𝐠 ☑ 𝐅𝐃𝐀 𝐩𝐫𝐞-𝐦𝐚𝐫𝐤𝐞𝐭 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 ☑ 𝐂𝐄 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐬𝐮𝐩𝐩𝐨𝐫𝐭 ☑ 𝐋𝐨𝐜𝐚𝐥 𝐑𝐞𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐯𝐞 ☑ 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 ☑ 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠   To stay up to date visit the dedicated page on our website >> https://lnkd.in/dpZpCUEC   #Thema #MD #MedicalDevices #IVD #RegulatoryAffairs #LetUsTakeCareBeyondBoundaries #USMarketExpansion

Here I provide a brief insight into the in-house IVD regulatory pathway! Please do not hesitate to contact us if you need any guidance. #IVD #IVDR #MedTech #clinicallaboratory #laboratory #health #regulatory #CMGMedDev

🌟 Exciting Announcement: Access Medical Device and IVD Markets at the Flagship Regulatory Event of the Year — MedTech Summit 🌟 REGISTER WITH OUR EXCLUSIVE CODE MTCHVITRO24 TO SAVE 15% OFF YOUR PASS This industry leading event allows the opportunity to save time, effort and money while ensuring compliance with global regulations and engaging with the EU Commission, Notified Bodies, Competent Authorities, Working Groups and Manufacturers. 📅 Event Date: 10-14 June, 2024 📍 Location: Brussels, BE (Virtual Passes Available) What to expect at the MedTech Summit: ·Insightful Keynotes: Hear from top industry leaders and visionaries. ·Engaging Sessions: 8 Topics ranging from, EU Medical Device Regulations, Medical Device Law & Compliance, Biocompatibility for Medical Devices, In Vitro Diagnostic Regulations, Clinical Evals and Investigations, Software and AI for Medical Devices and IVDs, Regulatory Affairs in Global Markets, Medial Device Regulatory Project Management ·Networking Opportunities: 350+ Medical Device and In Vitro Diagnostic leaders have already registered to attend this year’s Summit. Will you be joining them? Whether you're looking to stay ahead of industry trends, enhance your knowledge, or build meaningful connections, the MedTech Summit 2024 is the place to be. 🔍 Download the Brochure: https://bit.ly/4aqGELA 👉 Register Now & Save 15%: https://bit.ly/3V8C2Wb #medtech #medtechsummit #medicaldevices #invitrodiagnostic #mdr #ivd #invitro#eumdr #brussels #belgium #ai #software #law #clinicalevaluations #pms #vigilance #regulatoryaffairs