APPLICATIONS

• Sent to SANTE/F:
• 28 – MDR
35
• 7 – IVDR

• Scope coverage: overall, the entirety of MDR and

IVD codes
1
PRELIMINARY ASSESSMENT REPORTS

• Received by SANTE/F:
• 20 – MDR
25
• 5 – IVDR

2
 ON-THE-SPOT ASSESSMENTS
• Carried out: 12 • Scheduled: 13
• April: 3 MDR • Oct.: 1 MDR
• June: 4 MDR • Nov.: 3 MDR + 2 IVDR
• July: 1 IVDR • Dec.: 2 MDR + 1 IVDR
• Sep.: 2 MDR + 1 IVDR • Jan. 2019: 4 MDR
• Oct.: 1 MDR

3
ASSESSMENTS SCHEDULED PER WEEK

MDR
IVDR
1

0
15 17 23 25 27 36 38 41 43 45 47 49 50 3 5
4
 POST-ASSESSMENT ACTIVITIES
• 7 CAPA plans received by SANTE/F
 JAT reviews
• 4 issued (3 MDR + 1 IVDR)
• 3 under preparation
• 1 DA's final report received
 JAT final opinion issued
5