https://www.bsigroup.com/en-AU/insights-and-media/insights/brochures/ivdr-timeline/
Explore the timeline for compliance with the In Vitro Diagnostic Regulation (IVDR), ensuring your products meet regulatory requirements on time.
ivdrtimelinebsi
https://www.bsigroup.com/en-SG/insights-and-media/insights/case-studies/simplified-management-of-mdr-ivdr-documents-for-streamlined-compliance/
Explore how simplified management of MDR and IVDR documents can streamline compliance, ensuring efficient regulatory processes.
easymanagementmdrivdrdocuments
https://www.sgs.com/en-vn/webinars/2025/09/post-market-surveillance-under-ivdr-a-guide-for-ivd-professionals
Join our webinar to gain practical insights into PMS under the IVDR, including key requirements, methods and best practices for building a compliant and...
post market surveillanceivdrguideprofessionals
https://www.bsigroup.com/en-NZ/insights-and-media/insights/brochures/ivdr-documentation-submission/
Get detailed guidance on documentation submission requirements under the In Vitro Diagnostic Regulation (IVDR) with BSI's informative brochure.
ivdrdocumentationsubmissionbsi
https://www.medicaldevice-network.com/news/medica-2025-ivdr-having-detrimental-effect-on-ivd-innovation-in-europe/
Nov 17, 2025 - The dictates of the in vitro diagnostic regulation (IVDR) and “bureaucratic” issues are dampening the industry’s innovation aims.
medicaivdrdetrimentaleffectinnovation
https://www.bsigroup.com/pl-PL/training-courses/ivd-directive-ivdd-to-ivd-regulation-ivdr-transition-training-course/
Highlighting the key changes to requirements for CE marking following the publication of the new IVDR (In Vitro Diagnostic Regulation) (IVDR).
ivddivdrtransitiontrainingcourse
https://www.biospace.com/qiagen-receives-european-ivdr-certification-for-qiagen-clinical-insight-interpret-its-medical-device-software-for-clinical-decision-support
QIAGEN announced an updated version of its clinical decision support platform, QIAGEN Clinical Insight Interpret for NGS molecular profiling of hereditary and...
qiagenreceiveseuropeanivdrcertification
https://www.bsigroup.com/en-ZA/insights-and-media/insights/brochures/ivdr-documentation-submission/
Get detailed guidance on documentation submission requirements under the In Vitro Diagnostic Regulation (IVDR) with BSI's informative brochure.
ivdrdocumentationsubmissionbsi
https://www.sgs.com/en-kg/whitepapers/pms-requirements-under-ivdr-form
This white paper provides a comprehensive guide to Post-Market Surveillance (PMS) requirements under IVDR, detailing essential processes, documentation and...
pmsrequirementsivdrsgskyrgyzstan
https://www.bsigroup.com/en-ID/insights-and-media/media-centre/press-releases/2024/september/rollout-of-eu-reference-laboratories-for-ivdr-class-d-devices/
Class D IVD manufacturers will gain more insights in the newly enrolled EURL regulation and will be better prepared for the engagement between BSI and the...
class drollouteureferencelaboratories
https://www.sgs.com/en-ke/publications/quality-insights-magazine/quality-insights-volume-23-focusing-on-ivdr-health-and-safety-fsma-204-and-digital-trust
From the In Vitro Diagnostic Regulation (IVDR) and further ISO 45001 accreditation to FSMA 204 compliance and cybersecurity issues, organizations have many...
health and safetyqualityinsightsvolumefocusing
https://www.bsigroup.com/en-CZ/insights-and-media/media/webinars/rollout-of-eu-reference-laboratories-for-ivdr-class-d-devices/
Class D IVD manufacturers will gain insights in the newly enrolled EURL regulation and will be better prepared for the engagement between BSI and the EURLs.
class drollouteureferencelaboratories
https://www.bsigroup.com/en-NL/insights-and-media/media/webinars/extension-to-ivdr-transition-timelines-webinar/
Learn about the Extension to IVDR transition timelines.
extensionivdrtransitiontimelineswebinar
https://www.sgs.com/en-vn/webinars/2025/07/what-to-expect-during-an-ivdr-audit
This webinar will provide an overview of the QMS audit process under the IVDR and share practical guidance to help manufacturers prepare effectively.
expectivdrauditsgsvietnam
https://www.bsigroup.com/en-MY/insights-and-media/insights/brochures/ivdr-documentation-submission/
Get detailed guidance on documentation submission requirements under the In Vitro Diagnostic Regulation (IVDR) with BSI's informative brochure.
ivdrdocumentationsubmissionbsi
https://cdx-readiness.qbdgroup.com/
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...
cdxivdrassessmentqbdgroup
https://www.bsigroup.com/en-CA/insights-and-media/insights/brochures/ivdr-documentation-submission/
Get detailed guidance on documentation submission requirements under the In Vitro Diagnostic Regulation (IVDR) with BSI's informative brochure.
ivdrdocumentationsubmissionbsi
https://www.bsigroup.com/nl-BE/insights-and-media/insights/brochures/ivdr-transition-guidance/
This brochure covers key details on IVDR transition key steps according to Amending Regulation 2024/1860.
ivdrtransitionguidancebsi
https://www.bsigroup.com/en-IE/products-and-services/medical-devices/ivdr/
Transition to In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 with a full scope notified body and the expertise of a BSI team of technical specialists.
in vitrodiagnosticregulationivdrbsi
https://www.bsigroup.com/en-GB/insights-and-media/media/webinars/understanding-and-meeting-the-eu-ivdr-requirements-for-in-vitro-diagnostics-ivd-kits/
In vitro diagnostic medical devices (EU) 2017/746 definitions that reflect changes in technology, progress in diagnostics and regulatory oversight.
the euunderstandingmeetingivdrrequirements
https://www.sgs.com/en-bh/publications/quality-insights-magazine/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...
on thequalityinsightsvolumefocusing
https://www.biomerieux.com/corp/en/our-offer/product-quality-and-safety/ivdr.html
Discover what we do to ensure product quality & safety in regards to IVDR (in vitro diagnostics regulation).
ivdrpioneeringdiagnostics
https://www.bsigroup.com/en-NL/training-courses/implementation-of-the-in-vitro-diagnostic-device-regulation-ivdr-for-ce-marking-on-demand-elearning-course/
Implementation of the In Vitro Diagnostic Device Regulation course aims to offer guidance on implementation of the requirements stipulated into your business
ce markingon demandimplementationivdrelearning