207 results on '"Diagnostic reagents -- Laws, regulations and rules"'
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2. Medical Devices Regulations - Obligation To Notify Supply Issues Commences On 10 January 2025
3. The European Commission Launches Public Consultation On The MDR And IVDR
4. Investigators from University of Utah Health Release New Data on Clinical Pathology (Laboratory-developed Tests and In Vitro Diagnostics: a Regulatory Overview for Anatomic Pathology)
5. New mission to strengthen the implementation of medical technology regulations
6. Agilent Companion Diagnostic Assay PD-L1 IHC 28-8 pharmDx Receives European IVDR Certification
7. BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS
8. UPDATED: BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS
9. UPDATED: BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS
10. BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS
11. The Regulation Amending The Medical Devices Regulation And The Regulation Amending The In Vitro Diagnostic Medical Devices Regulation Have Been Published In The Legal Gazette
12. Application route for performance studies under the In Vitro Diagnostics Regulations in Northern Ireland
13. APPLICATION ROUTE FOR PERFORMANCE STUDIES UNDER THE IN VITRO DIAGNOSTICS REGULATIONS IN NORTHERN IRELAND
14. Adaptive Announced IVDR Certification for clonoSEQ(r) in European Union
15. Adaptive Announces IVDR Certification for clonoSEQ(R) in European Union
16. TİTCK Medical Device Regulations Harmonised With The European Union Legislation
17. Transition Periods Under The IVDR Extended
18. Peru : Digemid granted certification of Good Manufacturing Practices to the INS diagnostic reagents laboratory
19. Peru : Certification of Good Manufacturing Practices is granted to the laboratory of the National Institute of Health
20. Austria : EU law: avoiding shortages of medical devices and simplifying regulations
21. FDA Eyes Global AI Partnerships to Safeguard Patient Data
22. FDA Finalizes New Rule For Lab-Developed Tests
23. FDA's New Rule Regulates Lab-Developed Tests Under FD&C Act
24. Medical devices: new guidance for industry and notified bodies
25. FDA LDT Rule Raises Question Of Whether FDA Should Regulate Diagnostic Testing
26. LDT Oversight Gets Long-Awaited FDA Final Rule
27. FDA Announces Final Regulation Governing Laboratory Developed Tests
28. FDA Issues Final Rule On Regulation Of Laboratory Developed Tests
29. FDA FINALIZES RULE ON LABORATORY-DEVELOPED TESTS
30. FDA ISSUES FINAL RULE APPLYING MEDICAL DEVICE RULES TO LABORATORY DEVELOPED TESTS
31. ADVAMED STATEMENT ON THE RELEASE OF FDA RULE ON LABORATORY-DEVELOPED TESTS
32. Austria : Introduction of the Eudamed database to be accelerated
33. The Danish Medicines Agency Has Designated A New Danish Body For Certification Of Medical Devices
34. TUV SUD still has capacity for medical devices
35. IVD Survival Guide: Navigating Uncertainty in the US and European IVD Regulatory Landscape, Upcoming Webinar Hosted by Xtalks
36. IVD Survival Guide: Navigating Uncertainty in the US and European IVD Regulatory Landscape, Upcoming Webinar Hosted by Xtalks
37. Twist Bioscience unveils IVDR-compliant precision Dx products
38. Commission Proposes Extension To IVDR Transition Periods And Accelerated Launch Of Eudamed
39. European Commission adopts proposal to delay MDR deadlines: With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns about widespread product shortages in the EU market have been qrowinq
40. Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users, Upcoming Webinar Hosted by Xtalks
41. Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users, Upcoming Webinar Hosted by Xtalks
42. Updates To Manual On Borderline And Classification Of Medical Devices
43. Medical Device Development and Market Strategy: Europe or US First? Or Both? Upcoming Webinar Hosted by Xtalks
44. FDA TO HOST WEBINAR ON PROPOSED RULE FOR LABORATORY DEVELOPED TESTS
45. KHB Becomes First Chinese Company to Obtained EU Class D IVDR Certification for Its Rapid Test HIV Colloidal Gold Diagnostic Kit
46. FDA ISSUES PROPOSED RULE ON LABORATORY DEVELOPED TESTS
47. PHC Receives EU-MDR Certification
48. A Bottleneck in Certification of Medical Devices Could Impact Patient Care in the EU: A proposed extension for the implementation period of new regulation might help, but companies need to be diligent
49. FDA PROPOSES ENFORCING REQUIREMENTS FOR LABORATORY DEVELOPED TESTS
50. Agilent earns European IVDR certification for CDx assay
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