The Medical Devices Introductory Course 2020

Vigilance

Q: Has there been an increase in frequency or severity of these expected and foreseeable side effects ?

G: Even if an event is considered to be an acceptable side effect, and it is properly documented as such, the manufacturer must still consider sending a trend report if the event is representative of a negative trend. A clinician or other suitably qualified expert should be consulted.

Ex: Using the previous example, if the manufacturer finds that they are receiving increasing numbers of reports of haematoma from a particular syringe product, then it may be necessary to provide the appropriate authorities with a trend report.

The Organisation for Professionals in Regulatory Affairs

Vigilance

Q :Is this incident or incident type subject to a periodic summary reporting (PSR) agreement with a competent authority ?

G : PSR is a system of including multiple similar vigilance reports in one summary report. It can only be applied if agreed in advance between the manufacturer and the relevant CA. The format and frequency of a PSR must also be agreed

Ex: Incidents of Glass Vacutainer tubes which broke during use might be reported every 6 months in a PSR. Although glass breakage may be considered to be a reportable event (broken glass having the potential to cut) it is also a failure which could be considered as inherrent in the use of such a product. The manufacturer may therefore wish to discuss the possibility of periodic summary reporting with the relevant CA

The Organisation for Professionals in Regulatory Affairs