13.03.2017 – IVD WG Meeting

• IVD WG – 20170313 – Procedures for IVD performance studies – Competent authority perspective
• IVD WG – 20170313 – Report Dirk Stynen – IVD Technical Group Meeting 13 3 17
• IVD WG – 20170313 – Point 9a Presentation L. de Vries – Clinical performance studies CDx 13 March 2017
• IVD WG – 20170313 – Point 9 EMA 13 March 2017
• IVD WG – 20170313 – Point 8 – Performance evaluation LRQA 13 March 2017
• IVD WG – 20170313 – Point 7 MDR IVDR Stakeholders Meeting – 170217 CAMD – MDR IVDR Implementation priorities
• IVD WG – 20170313 – MTE slides_perf ev__IVD TG 13 March 2017
• IVD WG – 20170313 – IVD-R and regulatory challenges in the field of Companion Diagnostics
• IVD WG – 20170313 – Invitation IVD 2017 03 13 – Stakeholders
• IVD WG – 20170313 – IVD Regulation COR1
• IVD WG – 20170313 – HPRA PerformanceEvaluation_JM – Coordinated assessment
• IVD WG – 20170313 – EU Reference Laboratories 13 03 2017
• IVD WG – 20170313 – EU Ref Labs – expert panels TimRaemaekers
• IVD WG – 20170313 – EBE-EFPIA_IVDR and regulatory challenges_CDx_13 march 2017
• IVD WG – 20170313 – Developments in the field of Vigilance – TimRaemaekers_v3 –
• IVD WG – 20170313 – Companion Diagnostics under the IVD-R – Medtech Europe
• IVD WG – 20170313 – CDx IVD Technical Group UL 13 march 2017
• IVD WG – 20170313 – Companion Diagnostics IVD TG 13 03 2017
• IVD WG – 20170313 – Agenda Point 3 priorities and EURL 13 march 2017
• IVD WG – 20170313 – Annex to Commission decision on CTS for HIV self testing 13 03 2017
• IVD WG – 20170313 – Agenda – Stakeholders