Medfiles’ Post

In-vitro diagnostic medical devices (IVDs) play a key role in the UK's healthcare system. As the IVD industry continues to advance rapidly, so does the future regulatory framework for medical devices. Currently, the MHRA is focused on delivering the future regulatory framework for medical devices. Some key achievements by the MHRA include: ➡️ Publication of the government response to the public consultation on the future regulation of medical devices in the United Kingdom. ➡️ The establishment of an Innovative Devices Access Pathway pilot. ➡️ Guidance on Software as a medical device ➡️ The laying of regulations for IVD devices in Northern Ireland to lay down proportionate penalties. Learn more: https://heyor.ca/1RDFOp #IVD #MedicalDevices #InVitroDiagnosticMedicalDevices

❕ Are you prepared for the MDR transition deadline on 26 May 2024? The transition period for the Medical Device Regulation has been extended, but manufacturers must meet specific requirements by the upcoming deadlines to benefit from this extension: · No later than 26 May 2024, the manufacturer has put in place 𝐚 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐬𝐲𝐬𝐭𝐞𝐦 𝐢𝐧 𝐚𝐜𝐜𝐨𝐫𝐝𝐚𝐧𝐜𝐞 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐌𝐃𝐑. · No later than 26 May 2024, the manufacturer or the authorised representative has 𝐥𝐨𝐝𝐠𝐞𝐝 𝐚 𝐟𝐨𝐫𝐦𝐚𝐥 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐰𝐢𝐭𝐡 𝐚 𝐧𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐛𝐨𝐝𝐲 for conformity assessment in respect of the device or a device intended to substitute that device. For detailed information about the MDR transition, including insights on medical device and IVD class changes, read our blog ➡ https://lnkd.in/emiy4XUj #medicaldevice #MD #MDR

The European Commission published Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 "amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices" This legislative act provides that legacy IVDD devices may benefit from the extended transition period only if - the device continues to comply with IVDD requirements - there are no significant changes in the design or intended use of the device - the device does not present an unacceptable risk to patient health and safety - the manufacturer has implemented an IVDR-compliant QMS by 25 May 2025 - The manufacturer has submitted a formal application to a Notified Body by May 2025 for IVDD certified and self-declared class D devices, by May 2026 for self-declared class C IVDs and by May 2027 for self-declared class B and A-terile IVDs - The manufacturer has signed a written agreement with a notified body by September 2025 for certified IVDD and self-declared Class D devices, by September 2026 for self-declared Class C IVDs and by September 2027 for self-declared Class B and A-terile IVDs. If the above requirements are met, the transition period is extended to: - 31 December 2027 for certified IVDDs and self-declared Class D devices - 31 December 2028 for self-declared Class C devices - 31 December 2029 for self-declared Class B and Class A devices. Source: https://lnkd.in/epV2RwXM #ivdd #ivdr #regulationeu #extendedtransitionperiod #EuropeanCommission #regulatoryaffairs #qualityassurance #vlfconsulting

Hello MDCG Guidances! As October comes to an end, here are a few guidance documents that were published/updated in October 2024.   🍂 MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices.   🍂 MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams.   🍂 MDCG 2021-25 rev.1 Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. Links to the guidance documents in the comments field below 👇   Would you like to discuss what the impact of these updates could mean for you? Feel free to get in touch with us at Prevas! medtech@prevas.se, Anna-Karin Alm or Johan Sköld #MDR #MedicalDevices #RegulatoryAffairs #QMS #MDCG

This press release, dated October 24, 2024, outlines Team-NB's views and strategies regarding the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the European Union. Team-NB, the European Association of Medical Devices Notified Bodies, highlights the critical role of Notified Bodies in ensuring the safety and performance of medical devices and IVDs in the EU market. Key points include: - Notified Bodies increased capacity and staffing to meet MDR/IVDR demands - Challenges faced due to delays in manufacturer submissions - Recommendations for simplifying and consolidating regulatory approaches - Support for harmonized fast-track pathways for breakthrough and life-saving products - Endorsement of an updated Code of Conduct for improved transparency and predictability #MDR/IVDR#Medicaldevices#IVD

❗ Remember the upcoming deadline on 26 May 2024 for legacy medical devices if you want to benefit from the MDR transition period. Read more from the post below.

🚀 **EU IVDR Update!** 🚀 The Medical Device Coordination Group (MDCG) published the revised "MDCG 2020-16 rev.3 Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746." This update offers essential guidance for manufacturers, notified bodies, and health institutions on IVD classification before market placement or service in the EU. Key revisions include adding a ‘kit’ definition, updated examples for Rule 3(a) and Rule 6, and revisions of Rule 4(a) and Rule 5(c). This document supersedes the previous version from February 2023. Stay informed on the latest regulatory changes! #IVDR #MedicalDevices #RegulationUpdate #MDCG #IVD2017/746 #compliance #healthtech

🌐 Join Our Medical Webinar: Navigating the IVDR Landscape - A Guide to Device Classification and Requirements 📅 Date: November 21, 2024 🕒 Time: 9:00 am and 3:00 pm CET 🎤 Speaker: Ellen van Loon, Technical File Reviewer for IVDR, DEKRA Are you a manufacturer preparing to navigate the IVDR CE marking process for in vitro diagnostic (IVD) devices? Join us for this informative medical webinar designed to guide you through the regulatory landscape of the IVDR. Key Topics: ✅ Device Classification: Learn the details of risk classification under the new IVDR regulation. ✅ Conformity Assessment: Explore the specific assessment requirements based on device classification. ✅ IVDR Transitional Period: Stay informed on the latest amendment impacting medical device compliance. Why Attend? This webinar will provide the basic knowledge needed to: ✅ Classify IVD devices and understand the regulatory implications. ✅ Prepare for necessary conformity assessments. ✅ Keep up-to-date on changes affecting medical device compliance. Who Should Attend? This session is ideal for manufacturers and startups working with IVD products. Sign up now for our free webinar: https://brnw.ch/21wO1e0 #IVDR #IVDDevices #Compliance #CEMarking #MedicalDevices #MedicalDeviceRegulation #Webinar #IVDRRegulations

Today the EU Commission published on the OJEU Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. Only IVDD legacy devices may benefit from the extended transition period if: • The device continues to comply with IVDD requirements • There are no significant changes in design or intended purpose or the device • The device does not present an unacceptable risk to the health and safety of patient • The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025 • The manufacturer has lodged a formal application with a NB by May 2025 for IVDD certified and class D self-declared devices, by May 2026 for Class C self-declared IVDs and by May 2027 for class B and A-Sterile self-declared IVDs • The manufacturer has signed a written agreement with a NB by September 2025 for IVDD certified and class D self-declared devices, by September 2026 for Class C self-declared IVDs and by September 2027 for class B and A-Sterile self-declared IVDs If the above requirements are fulfilled, the transition period is extended to: • 31 December 2027 for IVDD certified devices and Class D self-declared devices • 31 December 2028 for Class C self-declared devices • 31 December 2029 for Class B and A-Sterile self-declared devices To access the Amending Regulation text click: https://bit.ly/4eSflgP Follow us for upcoming updates and stay tuned for additional guidance! #BSI #MedicalDevices #IVDR #EUDAMED #AmendingRegulation

🌐 Join Our Medical Webinar: Navigating the IVDR Landscape - A Guide to Device Classification and Requirements 📅 Date: November 21, 2024 🕒 Time: 9:00 am and 3:00 pm CET 🎤 Speaker: Ellen van Loon, Technical File Reviewer for IVDR, DEKRA Are you a manufacturer preparing to navigate the IVDR CE marking process for in vitro diagnostic (IVD) devices? Join us for this informative medical webinar designed to guide you through the regulatory landscape of the IVDR. Key Topics: ✅ Device Classification: Learn the details of risk classification under the new IVDR regulation. ✅ Conformity Assessment: Explore the specific assessment requirements based on device classification. ✅ IVDR Transitional Period: Stay informed on the latest amendment impacting medical device compliance. Why Attend? This webinar will provide the basic knowledge needed to: ✅ Classify IVD devices and understand the regulatory implications. ✅ Prepare for necessary conformity assessments. ✅ Keep up-to-date on changes affecting medical device compliance. Who Should Attend? This session is ideal for manufacturers and startups working with IVD products. Sign up now for our free webinar: https://brnw.ch/21wOreM #IVDR #IVDDevices #Compliance #CEMarking #MedicalDevices #MedicalDeviceRegulation #Webinar #IVDRRegulations