DQS’ Post

🌟 𝗢𝗻𝗹𝗶𝗻𝗲 𝗦𝗲𝗺𝗶𝗻𝗮𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗠𝗗𝗥)🌟 This seminar is for all English-speaking professionals within the EU and the US. The requirements of the #MDR have applied to all 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 sold in the EU since 26 May 2021. In March 2023, the Regulation (EU) 2023/607 was formalised. With this amended regulation, manufacturers of medical devices now have more time to certify their medical devices. However, the extension of the transitional period is subject to clear conditions. 𝗠𝗮𝗻𝘆 𝗻𝗲𝘄 𝗮𝗻𝗱 𝗰𝗵𝗮𝗻𝗴𝗲𝗱 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 raise numerous questions, such as: the #classification of medical devices, the requirements for 𝗽𝗿𝗼𝗼𝗳 𝗼𝗳 𝘀𝗮𝗳𝗲𝘁𝘆 and 𝗽𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲, as well as the many revised requirements for 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻, 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻, 𝗽𝗼𝘀𝘁-𝗺𝗮𝗿𝗸𝗲𝘁 𝘀𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲, 𝗘𝗨𝗗𝗔𝗠𝗘𝗗, 𝗨𝗗𝗜, and many more. In this interactive seminar, you will explore the diverse requirements of the MDR and gain practical advice on how to implement them within your company. 𝗬𝗼𝘂𝗿 𝗯𝗲𝗻𝗲𝗳𝗶𝘁𝘀 📌 You will receive an up-to-date overview of the regulation and the requirements of the MDR. 📌 You know how to implement the new requirements in your company. 📌 They know the connections and interfaces of the various departments and understand the big picture.   📅 Date: 12-16 August 2024 🕛 Time: 03:00 pm – 05:00 pm each day (MEZ) 📝 Registration: https://lnkd.in/ecin2yg6   #MedicalDevices #MDR #MedicalDeviceRegulation #EURegulations #HealthcareCompliance #RegulatoryAffairs #MedTech #MedicalDeviceCertification #HealthcareIndustry

The Differences between EU MDR vs. EU IVDR If you are involved with medical devices in the EU. It's essential to understand the specific regulations that apply to your products. Here's a clear comparison to help you navigate these complex standards: - EU MDR is designed for all medical devices for human use within the EU. - EU IVDR focuses solely on in vitro diagnostic medical devices. Both regulations mandate: - Unique Device Identification (UDI) for tracking. - Rigorous pre-market and post-market data requirements to ensure safety and effectiveness. Key Highlights EU MDR requires clinical evaluation reports, applicable to a wide range of medical devices. EU IVDR demands detailed performance evaluations, catering primarily to diagnostic devices. Stay ahead in the industry by ensuring your products meet these stringent EU standards! Stay Compliant with Acquis – Click Here to Learn How We Can Help!** #EURegulations #MedicalDevices #HealthTech #ComplianceSolutions #Acquis

EU MDR / IVDR News!! (Eudamed and IVDR Extension) Today (30-May) the Council of the European Union has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: • Further extending the transition period for certain IVDs • Enabling a gradual roll-out of EUDAMED, the new electronic database • Requiring manufacturers to flag up potential shortages of critical medical devices and IVDs "Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices" was first proposed in January 2024 with the aim of mitigating shortages of critical medical devices. The new regulation adopted today will enter into force following publication in the EU’s Official Journal. Link to council press release: https://lnkd.in/d7EXSVym 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 #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations

⏰ The clock is ticking towards the extended deadline of May 26, 2024, for the EU Medical Device Regulation (EU MDR) transition. It's crucial for manufacturers of medical devices to take action now to ensure compliance and continuity in the market. 📅 Key Dates and Requirements: To extend the validity period of certificates issued under the Directives until 2027 or 2028, manufacturers must submit a formal MDR certification application to a Notified Body by May 26, 2024. This includes setting up an MDR-compliant quality management system and ensuring no significant changes in device design or intended purpose. 📝 Documentation Requirements: A comprehensive package demonstrating compliance with Regulation 2023/607 should include essential documents such as the manufacturer's declaration, application with the notified body designated for the MDR, agreement with the notified body, and CE marking certificate with the Directive. 📣 Action Steps: Manufacturers must act swiftly to meet the impending deadlines and ensure a smooth transition to the MDR. This includes engaging with notified bodies, updating quality management systems, and securing necessary documentation to maintain market access for their devices. 🌟 Looking Ahead: As the first deadline for Regulation 2023/607 draws near, manufacturers must remain vigilant and proactive in their approach to compliance. By staying informed, prepared, and proactive, companies can navigate the transition successfully and continue to deliver safe and effective medical devices to patients across the EU. Meet the deadline! Contact us: https://lnkd.in/gpVm8W2 Learn more: https://lnkd.in/dTSXFAE2 #MDR #medicaldevices #pharmalex

For manufacturers and #NotifiedBodies of #MedicalDevices in #Europe. 🇪🇺 The Medical Device Coordination Group #MDCG has released Revision 2 of their guidance document on appropriate surveillance for legacy medical devices under the #MDR’s (Medical Devices Regulation) transitional provisions (Article 120). This revision reflects recent regulatory changes from Regulation (EU) 2023/607. The MDR allows certain legacy devices, under specific conditions, to remain on the market until established deadlines (depending on classification). A crucial requirement for this extended market access is continued appropriate surveillance by a notified body. This updated guidance provides clarity on the activities involved in this surveillance, outlining expectations for both: 🔹 Manufacturers: The document clarifies their ongoing obligations regarding their quality management systems. Manufacturers must demonstrate they have processes in place to maintain compliance with the relevant regulations throughout the legacy device's lifecycle. 🔹 Notified Bodies: The guidance details the elements they should assess during surveillance, ensuring a thorough evaluation of the legacy device's continued safety and performance. This revision aligns with the position outlined by the MDCG in their previous document, MDCG 2022-14. Do you have any questions around the new amendments and its details, the transition or the conformity of your medical devices #MD and in vitro diagnostic medical devices #IVDs? Don’t hesitate to contact us. We are here to help. ☞ [email protected] #TransitionalProvisions #LegacyDevices #NotifiedBody #QualityManagementSystem #PatientSafety #RegulatoryAffairs #EURegulations #regulatorycompliance #readiness #medtechindustry #NB #healthcare #publichealth 

MEDIcept Minute: The Future of Europe’s Medical Technology from MedTech Europe  MedTech Europe’s recent Position Paper calls for comprehensive reform in three key areas: efficiency in the CE marking system, an innovation-friendly approach, and an accountable governance structure. They emphasize the need for discussions among stakeholders to initiate reforms while remaining committed to finding short-term solutions to implementation issues. Collaboration is urged to realize the original goals of the IVDR and MDR for the benefit of European patients and health systems. MedTech Europe and its members express support for the objectives of the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical Devices Regulation 2017/745/EU (MDR), aiming to establish a robust and transparent regulatory framework while supporting innovation. However, after nearly six and a half years of implementation, these regulations have not fully achieved their goals. Structural issues in the regulatory system, making it slow, unpredictable, costly, and complex, persist despite efforts to address short-term challenges.  Read MedTech’s full position paper at the link below. https://lnkd.in/d5eSBYgP Do you need assistance navigating IVDR and MDR? MEDIcept has regulatory experts who would love to help ensure that you are compliant with these regulations. Reach out to us today at [email protected] to learn more. #medtech #medicaltechnology #medicaldevices #EU #IVDR

🔍 News in Medical Device Regulation! 🔍 Attention all medical device professionals and stakeholders! A game-changing update is on the horizon that will reshape the landscape of medical device regulation in the European Union. 📝 Last year, an amendment of the MDR was published (EU) 2023/607) to extend the MDR transition period beyond 26 May 2024. Only legacy devices can benefit from this extended transitional period if certain conditions are fulfilled. For example, if the manufacturer does not apply for conformity assessment with a notified body by 26 May 2024, the transition period will end on 26 May 2024. 💡 Are you ready to navigate these regulatory changes effectively? At ECCRT, we understand the challenges that come with staying compliant in a rapidly evolving regulatory environment. That's why we're proud to offer our comprehensive Medical Device Regulation (MDR) course. 🎓 Our MDR course is designed to equip participants with the knowledge and skills needed to thrive in the new regulatory landscape. From understanding the key provisions of the MDR to implementing compliant business processes, our course covers it all. 🌐 With ECCRT's MDR course, you can stay ahead of the curve and ensure that your medical device endeavours meet the highest standards of quality and compliance. Don't wait until it's too late—invest in your professional development today and be ready for the future of medical device regulation! 🚀 Join us and take the next step towards excellence in medical device regulation. Learn more about our MDR course and register on For more information on the upcoming implementation of the MDR and its implications, visit the official website of the European Commission. #MedicalDevices #Regulation #ProfessionalDevelopment #MDR #ECCRT #MDRCourse #Compliance #QualityAssurance #PatientSafety #ResearchExcellence #EuropeanUnion

📢 EU MDR News Alert! 📢 The Medical Device Coordination Group (MDCG) has just released the MDCG 2024-3 Guidance on the content of the Clinical Investigation Plan (CIP) for clinical investigations of medical devices. Let’s dive into the details: 🔍 Purpose of the Guidance: This comprehensive document aims to assist sponsors in developing their Clinical Investigation Plans by providing detailed insights into the expected information within each CIP section. By preemptively addressing potential queries from competent authorities during the clinical investigation assessment, a well-structured CIP becomes a crucial tool for successful study execution. 📝 Key Points: Legally Required Content: Section 3 of Chapter II in Annex XV of the MDR outlines the essential content for the Clinical Investigation Plan. Good Clinical Practice: Sections 2.7 (Chapter I), 3.12 (Chapter II), and 4 and 6 (Chapter III) of Annex XV emphasize that clinical investigations must adhere to good clinical practice. 📚 Cross-Referencing Made Easy: The guidance aligns with the numbering of the regulation, facilitating seamless cross-referencing to legal requirements. 🌐 Explore More: For additional updates on MedTech, Pharma, BioTech, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, and Intelligence, visit TS Quality & Engineering page and website. 🚀 Stay Informed! 🚀 #intelligence #notifiedbody #notifiedbodies #audit #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations