Hi Andrea,
Sorry about the delay in response - been on my hols. The main proactive vigilance (as indicated in my SOP) is monitoring alerts, recalls etc - especially as they relate to yours or a similar product. I log the number of overall incidents each month (MAUDE, MHRA etc) on a spreadsheet. I also record anything in more detail on related products. If I find a new hazard I can then update my risk management section of the TF and/or update my Clinical Evaluation section of the TF. This way you can physically show your proactive activities to your NB. Also your proactive vigalance activities are how you deal with complaints (e.g. speed of response), dealing with 'incidents' (ouch!), continuing literature reviews, sales feedback (e.g. reorders) etc. You can also show a NB your emails from e.g. MHRA who give you automatic weekly/daily info on Field Safety Notices, Alerts etc and also include various publishing houses e.g. AdvaMed SmartBrief who give industry updates on a regular basis.
I hope this helps.
Steve