Category: In Vitro Diagnostic Medical Device Regulation IVDR

Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019

12 Jun, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation IVDR, MDCG - Medical Devices Coordination Group, Medical Device Regulation MDR
The next meeting of the MDCG is schedule for 20 June 2019. Some guidance are up for endorsement: Vigilance: Manufacturer Periodic Safety Report (MPSR) form – for endorsementImplant card guidance Guidance on Summary of safety and clinical performance Person responsible for regulatory compliance, guidance on article 15 MDR / IVDR These are some of the […]

Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices

10 Jun, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR, Unique Device Identification - UDI
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices