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https://www.arc-regulatory.com/insights/whitepapers/ Precision Medicine Whitepapers | IVDR & CDx Whitepapers | ARC precision medicine whitepapers ivdr cdx arc https://lne-gmed.com/news/article-10a-mdr-ivdr-new-guidance-documents Article 10a MDR / IVDR : New guidance documents - GMED Medical Device Certification Apr 29, 2026 - The European Commission has published updated reference documents related to Article 10a of the MDR and IVDR, addressing the information obligations in the even new guidance medical device article mdr ivdr https://www.horiba.com/tha/healthcare/news/news-press-release/detail/news/2/2023/ce-ivdr-marking-for-three-new-horiba-medical-analyzers/ CE IVDR Marking for three new HORIBA Medical analyzers - HORIBA HORIBA Medical announced announced the CE IVDR registration of three new Yumizen C clinical chemistry analyzers offering new levels of instrument and reagent... for three ce ivdr marking new https://www.emergobyul.com/news/ivd-devices-performance-evaluation-studies-clinical-performance-studies-what-has-changed Key differences between IVD clinical study requirements under the EU IVDD versus IVDR Part One of our series on IVD devices examines the differences between performance evaluation (PE) study requirements under the IVDD and clinical performance... https://mdi-europa.com/team-nb-issued-revision-2-of-ivdr-best-practice-document/ TEAM NB issued revision 2 of IVDR best practice document | mdi Europa team nb https://www.sgs.com/en-ee/news/2026/03/sgs-praised-for-prompt-precise-ivdr-service Praised for Prompt, Precise IVDR Service | SGS Estonia Discover why a client was so impressed by our fast and effective IVDR certification process that they decided to send two honors to our team. praised prompt precise ivdr service https://casusconsulting.com/services/europe/ivdr-ce-marking/ IVDR CE Marking: Deadlines, Steps & Requirements (2026) The IVDR date of application was 26 May 2022. Find out the transition periods, how to classify your IVD, and how to CE mark under the IVDR. ce marking ivdr deadlines steps requirements https://www.emergobyul.com/?page=6 Emergo by UL | Medical Device, IVDR Compliance and Human Factors Find out more about Emergo by UL, a renowned medical device consulting company with a focus on human aspects and international regulatory compliance for... medical device ul ivdr compliance human https://www.scilife.io/blog/ivdr-qms-requirements IVDR Complete Guide: How to Meet the QMS Requirements | Scilife Compliance with IVDR is key to ensuring the safety and efficacy of IVD products in the European market. Discover more by reading our IVDR complete guide! complete guide how to meet the ivdr qms https://rosapeak.com/fr/ivdr/ IVDR - rosapeakadvisors Jun 28, 2023 - The IVDR, which came into effect on May 26, 2022, introduced significant changes and more stringent regulations for in vitro diagnostic devices. ivdr https://www.medtecheurope.org/news-and-events/news/eu-commission-addressing-mdr-and-ivdr-challenges/ EU Commission addressing MDR and IVDR challenges - MedTech Europe Oct 5, 2022 - The situation surrounding MDR and IVDR is reaching a critical tipping point and all possible efforts must be thoroughly pursued in the interest of safeguarding... eu commission addressing mdr ivdr challenges https://www.sgs.com/en-id/publications/quality-insights-magazine/quality-insights-volume-23-focusing-on-ivdr-health-and-safety-fsma-204-and-digital-trust Quality Insights Volume 23: Focusing on IVDR, Health and Safety, FSMA 204 and Digital Trust | SGS... From the In Vitro Diagnostic Regulation (IVDR) and further ISO 45001 accreditation to FSMA 204 compliance and cybersecurity issues, organizations have many... https://www.gendx.com/ifu_translations/ifu-ngsgo-ampx-v2-7910000-ce-ivdr_dutch/ IFU NGSgo-AmpX v2 7910000 edition 7.1, 2025-07 CE (IVDR)_DUTCH - GenDx https://www.beckman.de/en/support/faq/industry-standards/ivdr-implications-for-individual-clinical-laboratories Does the IVDR have implications for individual clinical laboratories? Yes, in vitro diagnostic assays designed and manufactured in health institutions are within the scope of the IVDR. for individual ivdr implications clinical laboratories https://www.portamedica.eu/event-details-registration/deadline-lodge-an-application-for-ivdr-conformity-assessment-for-ivds-class-d Deadline Lodge an Application for IVDR Conformity Assessment for IVDs Class D | Porta Medica Deadline to lodge an application for IVDR conformity assessment for IVDs that would become Class D under IVDR in order to benefit from extended transition... https://www.sgs.com/en-sk/publications/mdr-and-ivdr-news MDR and IVDR News | SGS Slovakia Read about the latest Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) highlights and regulatory updates. Find out more. mdr ivdr news sgs slovakia https://bsi.learncentral.com/shop/Course.aspx?id=26911&name=Requirements+of+the+In+Vitro+Diagnostic+Regulation+(IVDR)+on+demand+Training+Course BSI Training - Requirements of the In Vitro Diagnostic Regulation (IVDR) on demand Training Course Requirements of the In Vitro Diagnostic Regulation (IVDR) on demand Training Course in vitro diagnostic https://www.bsigroup.com/en-PH/insights-and-media/media/webinars/navigating-the-complex-ivdr-landscape/ Navigating the Complex IVDR Landscape | BSI Learn to navigate the complex IVDR landscape with expert insights and practical compliance strategies. the complex navigating ivdr landscape bsi https://www.sgs.com/en-lk/publications/mdr-and-ivdr-news MDR and IVDR News | SGS Sri Lanka Read about the latest Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) highlights and regulatory updates. Find out more. mdr ivdr news sgs sri https://bsi.learncentral.com/shop/Course.aspx?id=26771&name=Pathways%20to%20IVDR%20compliance BSI Training - Pathways to IVDR compliance The webinar presents an overview of the key aspects of IVDR compliance, focusing on the common pitfalls related to the technical documentation and Performance... training pathways bsi ivdr compliance https://www.mtdialog.de/artikel/biobanken-medizinische-laboratorien-und-die-auswirkungen-der-ivdr Biobanken, medizinische Laboratorien und die Auswirkungen der IVDR - MT-Dialog Bericht vom 8. Nationalen Biobanken-Symposium im Dezember 2019 in Berlin biobanken medizinische laboratorien und die https://www.bsigroup.com/en-NZ/insights-and-media/media-centre/press-releases/2024-press-releases/may/bsi-first-notified-body-to-publish-its-capacity-lead-times-for-mdr-ivdr/ BSI first Notified Body to publish its capacity & lead times for MDR & IVDR | BSI https://www.kalmsconsulting.com/2021/10/11/the-in-vitro-diagnostic-regulation-ivdr-impact-on-market-access-in-the-european-union/ The In Vitro Diagnostic Regulation (IVDR): Impact on Market Access in the European Union | Kalms... Oct 11, 2021 - Namsa and Kalms Consulting are glad to invite you to the "IVDR: Impact on Market Access in the European Union" virtual summit. The event will take place on... in vitro diagnostic https://dispozitive.anm.ro/f1mdr-display?page=39 F1 MDR / F2 IVDR - ANMDMR Nomenclatorul Dispozitivelor Medicale mdr ivdr medicale https://www.metecon.de/en/leistungen-ivd/software/ IVD Software Compliance & IVDR | Metecon software compliance ivd https://laboratoriomdc.com/ Kits PCR IVDR and Life Sciences Research - Laboratorio MDC Oct 8, 2024 - Ámplia experiencia científica. Diagnóstico Molecular In Vitro. Investigación, más de 500 Kits Real Time PCR. Montaje de laboratorios. life sciences research kits pcr ivdr laboratorio https://www.orielstat.com/courses/eu-ivdr-training-2017-746 Implementation Training for the EU IVDR (In Vitro Diagnostic Regulation 2017/746) Oriel STAT A MATRIX offers several IVDR training classes covering all aspects of compliance with the European regulation. in vitro diagnostic implementation training for the eu ivdr https://www.orielstat.com/consulting/IVDD-IVDR-gap-analysis EU IVDD vs. IVDR Gap Analysis for IVD Manufacturers Oriel STAT A MATRIX helps IVD companies identify the gaps in their state of compliance with the In Vitro Diagnostic Regulation (2017/746). gap analysis eu ivdd vs ivdr https://www.emergobyul.com/?page=10 Emergo by UL | Medical Device, IVDR Compliance and Human Factors Find out more about Emergo by UL, a renowned medical device consulting company with a focus on human aspects and international regulatory compliance for... medical device ul ivdr compliance human https://www.decibio.com/product/impacts-of-european-in-vitro-diagnostic-regulation-ivdr-professor-of-molecular-medicine-uk-academic-hospital Impacts of European In Vitro Diagnostic Regulation (IVDR) - Professor of Molecular Medicine, UK... As part of an interview campaign to understand the impacts of European In Vitro Diagnostic Regulation (IVDR) on Clinical Labs, we spoke to a Professor of... in vitro diagnostic https://lne-gmed.com/archives/upcoming-revisions-of-eu-regulations-the-reclassification-of-in-vitro-diagnostics EU IVDR Revisions & IVD Reclassification | GMED May 5, 2026 - https://youtu.be/BvlsAUSbn7A Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not bei eu ivdr revisions reclassification gmed https://cdx-readiness.qbdgroup.com/ CDx IVDR Readiness Assessment | QbD Group Take this 3-minute self-check to see how your CDx clinical performance study aligns with IVDR and ISO 20916 requirements. Avoid costly delays and compliance... readiness assessment cdx ivdr qbd group https://www.metecon.de/en/news/wer-braucht-ein-qms-nach-mdr-ivdr-rollen-pflichten-und-eu-bescheinigungen-erklaert/u/1206/?showconsent=yes&cpage=4 QMS under MDR/IVDR: Roles, Obligations and EU Certificates Explained | Metecon Who needs a QMS under MDR and IVDR? This article systematically explains which economic operators are affected, which EU certificates are issued and what role... qms mdr ivdr roles https://lne-gmed.com/webinars/upcoming-revisions-of-eu-regulations-the-reclassification-of-in-vitro-diagnostics-2 EU IVDR Revisions & IVD Reclassification Webinar | GMED May 5, 2026 - https://youtu.be/BvlsAUSbn7A Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not bei eu ivdr revisions reclassification webinar gmed https://www.sgs.com/en-ie/publications/quality-insights-magazine/quality-insights-volume-23-focusing-on-ivdr-health-and-safety-fsma-204-and-digital-trust Quality Insights Volume 23: Focusing on IVDR, Health and Safety, FSMA 204 and Digital Trust | SGS... From the In Vitro Diagnostic Regulation (IVDR) and further ISO 45001 accreditation to FSMA 204 compliance and cybersecurity issues, organizations have many... https://www.awmf.org/aktuelles/awmf-aktuell/default-bb66242bba7af83f7b38071402e14718 Symposium der AWMF: Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und... https://www.decibio.com/product/impacts-of-european-in-vitro-diagnostic-regulation-ivdr-professor-of-oncology-and-head-of-pathology-italian-academic-medical-center Impacts of European In Vitro Diagnostic Regulation (IVDR) - Professor of Oncology and Head of... As part of an interview campaign to understand the impacts of European In Vitro Diagnostic Regulation (IVDR) on Clinical Labs, we spoke to a Professor of... in vitro diagnostic https://www.sgs.com/en-ge/publications/quality-insights-magazine/quality-insights-volume-24-focusing-on-the-vsme-ivdr-responsible-supply-chains-and-food-waste Quality Insights Volume 24: Focusing on the VSME, IVDR, responsible supply chains and food waste |... From end-to-end VSME services and IVDR fast-tracking to responsible supply chains and reducing food waste, organizations have much to sort while still offering... https://www.makrocare.com/blog/in-vitro-diagnostic-regulation-ivdr-general-aspects-key-features-and-limitations/ Understanding IVDR: Regulations, Risks & Realities of Medical Devices - MakroCare Explore the essentials of In Vitro Diagnostic Regulation (IVDR), including risk classification, regulatory requirements, and limitations. Delve deeper now. understanding ivdr medical devices regulations risks realities https://www.thermofisher.com/us/en/home/clinical/ivdr.html In Vitro Diagnostic Regulation (IVDR) | Thermo Fisher Scientific - US Overcome the complexities of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) transition. Learn how Thermo Fisher Scientific can help. in vitro diagnostic thermo fisher scientific regulation ivdr us https://www.sgs.com/en-nz/publications/mdr-and-ivdr-news MDR and IVDR News | SGS New Zealand Read about the latest Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) highlights and regulatory updates. Find out more. mdr ivdr news sgs zealand https://www.iss-ag.ch/de/blog-articles/scientific-validity-under-the-ivdr-a-critical-requirement-for-ivd-market-access Scientific Validity under the IVDR: A Critical Requirement for IVD Market Access? ISS AG, Integrated Scientific Services, provides services to medtech companies for the development of medical devices and their introduction into the market. https://www.pcbc.gov.pl/pl/uslugi/szkolenia/szkolenia-specjalne/szkolenie-online-o215-przeglad-rozporzadzenia-sprawie-diagnostyki-in-vitro-ivdr-szkolenie-prowadzone-j-angielskim Szkolenie online O215 - Przegląd rozporządzenia w sprawie diagnostyki in vitro (IVDR)/ Review of... Jednodniowe szkolenie prowadzone w języku angielskim, poświęcone specyfice unijnego Rozporządzenia w sprawie diagnostyki in vitro (IVDR). https://www.mokalwer.it/dispositivi-medici-i-nuovi-regolamenti-europei-mdr-e-ivdr-2/ Dispositivi Medici: I Nuovi Regolamenti Europei MDR e IVDR - Mokalwer Jul 23, 2020 - Al fine di stabilire un quadro normativo solido sui Dispositivi Medici, le precedenti direttive sono state revisionate. Nuovi Regolamenti MDR e IVDR. dispositivi medici nuovi regolamenti europei mdr https://www.emergobyul.com/?mkt_tok=MTE3LVpMUi0zOTkAAAGEx1aSvlbE0_VBNJJEL3NK61pM7XgsmQQHgKaf_yEhB5L8T9gr0yUtwYQRhJUS1I9aKEuubYMZ8M5qSxhiIDIATDZvokRjgdlanGnjeEQIBCDi&page=26 Emergo by UL | Medical Device, IVDR Compliance and Human Factors Find out more about Emergo by UL, a renowned medical device consulting company with a focus on human aspects and international regulatory compliance for... medical device ul ivdr compliance human https://www.sysmex.de/footer-navigation/legal/rechtliches-agb-und-import-ivdr/ Rechtliches (AGB) und Import (IVDR) rechtliches agb und import ivdr https://www.qmlogic.com/ivdr-consultancy IVDR Consulting Services for IVD Devices & Software Get expert IVDR consulting for IVD devices and software. We support compliance, documentation, notified body selection, and ISO 13485 audits. ivdr consulting services for devices software https://www.bsigroup.com/th-TH/insights-and-media/media/webinars/renewal-under-uk-and-eu-legislations-for-mdr-ivdr-and-ukca/ Renewal under UK and EU Legislations for MDR, IVDR and UKCA | BSI Providing an overview of the process for renewals within BSI and how manufacturers should be submitting for this and what documentation is required. uk and eu renewal https://www.sqt-training.com/2021/04/medical-devices-update-on-harmonised-standards-for-the-mdr-and-the-ivdr-2/ Medical Devices - Update on Harmonised Standards for the MDR and the IVDR. - Oct 21, 2025 - The EU has approved a revised Standardisation Request requesting the European standards body CEN to produce Harmonised Standards which will give a presumption... medical devices harmonised standards for the update https://www.pcbc.gov.pl/pl/uslugi/szkolenia/przewodnik-po-swiecie-ivdr/szkolenie-online-o155-nowe-rozporzadzenia-wyroby-ivdr Szkolenie online O155 - Wprowadzenie do IVDR - Rozporządzenie Parlamentu Europejskiego i Rady (UE)... Szkolenie przedstawiające wymagania nowego Rozporządzenia Parlamentu Europejskiego i Rady dotyczącego wyrobów medycznych do diagnostyki in vitro, zastępującego... https://fast.wistia.com/embed/medias/js6rbfzoh2 BSI Medical Devices | IVDR Companion Diagnostics (CDx) Update medical devices companion diagnostics bsi ivdr cdx https://www.rimsys.io/libraries/mdr-ivdr-lessons-for-regulatory-strategy MDR & IVDR Lessons for Regulatory Strategy Gain insights into how lessons learned from the new MDR/IVDR regulations can be used to create stronger regulatory and revenue alignment. mdr ivdr lessons regulatory strategy https://www.sgs.com/en-sk/publications/quality-insights-magazine/quality-insights-volume-24-focusing-on-the-vsme-ivdr-responsible-supply-chains-and-food-waste Quality Insights Volume 24: Focusing on the VSME, IVDR, responsible supply chains and food waste |... From end-to-end VSME services and IVDR fast-tracking to responsible supply chains and reducing food waste, organizations have much to sort while still offering... https://pressreleasehub.pa.media/article/scopio-labs-achieves-eu-ivdr-certification-for-ai-powered-full-field-digital-morphology-platforms-68076.html Scopio Labs Achieves EU IVDR Certification for AI-Powered Full-Field Digital Morphology Platforms https://www.bsigroup.com/en-AU/insights-and-media/insights/brochures/ivdr-timeline/ IVDR Timeline | BSI Explore the timeline for compliance with the In Vitro Diagnostic Regulation (IVDR), ensuring your products meet regulatory requirements on time. ivdr timeline bsi https://www.qualtechs.com/de-de/aritcle/device-specific-vigilance-guidance-manufacturers Ensure Compliant Medical Device Reporting with DSVG | MDR & IVDR This Device Specific Vigilance Guidance (DSVG) helps manufacturers understand and fulfill medical device incident reporting requirements according to MDR and... medical device ensure compliant reporting mdr https://de-mdr-ivdr.tuvsud.com/Article-89-Evaluation-of-devices-suspected-of-presenting-an-unacceptable-risk-or-other-non-compliance.html Article 89 (IVDR): Evaluation of devices suspected of presenting an unacceptable risk or other... This page informs you about Article 89 of the In Vitro Diagnostic Medical Devices Directive (IVDR). Research all articles of the IVDR quickly and conveniently. https://resources.hoodin.com/post/mdr-ivdr-transition-the-structural-shift-that-didn-t-end-with-the-deadline MDR/IVDR Transition: The Structural Shift That Didn't End with the Deadline Mar 24, 2026 - Most discussions about the MDR and IVDR transition focus on deadlines, delays, and notified body bottlenecks. But for many manufacturers, the real, lasting... structural shift https://ivankamenken.com/compliance/eu-in-vitro-diagnostic-medical-devices-regulation-ivdr EU In Vitro Diagnostic Medical Devices Regulation (IVDR) Compliance Advisory | Ivanka Menken Expert EU In Vitro Diagnostic Medical Devices Regulation (IVDR) compliance advisory from Ivanka Menken. 23 controls across 6 domains. Free readiness assessment... in vitro diagnostic medical devices https://www.vinnova.se/en/p/regulatory-competence-building-in-preparation-for-ce-ivdr-for-ai-support-in-prostate-pathology/ Regulatory competence building in preparation for CE-IVDR for AI support in prostate pathology |... in preparation https://www.nhogeneo.no/arrangementer/2026/webinar-hva-betyr-endringene-i-mdr-ivdr-og-eudamed-for-medtek--leverandorene/ Webinar: Hva betyr endringene i MDR, IVDR og EUDAMED for medtek-leverandørene? Geopolitisk uro kan medføre konsekvenser for trygge og forutsigbare leveranser av medisinsk utstyr, laboratorieutstyr og helseteknologi. Hvilke plikter har du... https://www.sgs.com/en-mz/publications/quality-insights-magazine/quality-insights-volume-23-focusing-on-ivdr-health-and-safety-fsma-204-and-digital-trust Quality Insights Volume 23: Focusing on IVDR, Health and Safety, FSMA 204 and Digital Trust | SGS... From the In Vitro Diagnostic Regulation (IVDR) and further ISO 45001 accreditation to FSMA 204 compliance and cybersecurity issues, organizations have many... https://www.makrocare.com/blog/ivdr-latest-plan-of-action-from-mdcg/ IVDR: Latest plan of action from MDCG - MakroCare Learn the art and science of literature search for evidence-based projects. Discover the steps, methodology, and criteria for effective research. plan of action ivdr latest https://regulatorik-gesundheitswirtschaft.bio-pro.de/veranstaltungen/mdr-ivdr-treff MDR & IVDR Treff BW - Wegweiser Regulatorik Gesundheitswirtschaft BW mdr ivdr treff bw wegweiser https://www.medicaldevice-developments.com/news/alivedx-secures-ivdr-ce-mark-for-mosaiq-assay/ AliveDx secures IVDR-CE mark for MosaiQ assay to detect CD Sep 4, 2024 - AliveDx has secured IVDR-CE mark certification for its multiplexed MosaiQ AiPlex CD microarray immunoassay to diagnose celiac disease. ce mark secures ivdr https://www.sgs.com/en-co/publications/mdr-and-ivdr-news MDR and IVDR News | SGS Colombia Read about the latest Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) highlights and regulatory updates. Find out more. mdr ivdr news sgs colombia https://pmc.ncbi.nlm.nih.gov/articles/PMC9896441/ Structure and content of the EU-IVDR: Current status and implications for pathology - PMC Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April... https://www.biomerieux.com/us/en/our-offer/product-quality-and-safety/ivdr.html IVDR | Pioneering Diagnostics ivdr pioneering diagnostics https://casusconsulting.com/team-notified-body-ivdr-ce-mark-training-july-2024/ Team Notified Body: IVDR CE Training July 2024 - Casus Consulting Apr 15, 2024 - Team Notified Body (NB) has scheduled a fourth IVDR training session for Wednesday July 3, 2024. Find out the agenda, fee, and how to sign-up. notified body ce training team ivdr july