Module 16 2022

07/09/2022

Modus Operandi

 Think broadly and critically, don’t make assumptions, ask questions of yourself and others.  You should answer all the questions above for each scenario.  Justify each conclusion by reference to regulation or guidance  Discuss any additional, more general issues raised by each scenario

The Organisation for Professionals in Regulatory Affairs

7

MEDDEV 2.12/1 rev 8 .

2 Updated report forms • Annex 3 Report form for manufacturers to the NCA • Annex 4 Report form for Field Safety Corrective action • Annex 5 Template for FSN 2 New report forms • Annex 6 Manufacturers Periodic Summary Report • Annex 7 Manufacturers Trend Report Form • Annex 8 NCAR format(between NCAR participants only

The Organisation for Professionals in Regulatory Affairs

8

4