APPLICATIONS Sent to SANTE/F: 38 – MDR 9 – IVDR 47

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Presentation transcript:

APPLICATIONS Sent to SANTE/F: 38 – MDR 9 – IVDR 47 Scope coverage: overall, the entirety of MD and IVD codes 47

PRELIMINARY ASSESSMENT REPORTS Received by SANTE/F: 27 – MDR 6 – IVDR 1 JAT to be appointed 33

JOINT ASSESSMENTS per WEEK

NUMBER OF ON-SITE DIVERGING OPINIONS DATA AS OF 26/03/2019

POST-ASSESSMENT ACTIVITIES 11 CAPA plans received by SANTE/F 7 JAT opinions issued 1 CAPA plans undergoing official translation 3 JAT opinions under preparation 2 Designating authorities' final reports received 2 JAT opinion issued 1 MDCG recommendation