Division 1.3 Review of the risk assessment

The manufacturer must establish and maintain a systematic procedure to review information gained about the medical device or similar devices in the post-production phase. The information must be evaluated for possible relevance to safety, especially in any of the following cases:

1. (a)

   previously unrecognised hazards are identified;

2. (b)

   the estimated risk arising from a hazard has changed or is no longer acceptable;

3. (c)

   the original assessment is otherwise invalidated.

In the cases set out in points (a), (b) or (c), the manufacturer shall feed back the results of the evaluation as an input to the risk management process.

In the light of this new information, a review of the appropriate risk management measures for the device must be considered (including rationale for choosing an animal tissue or derivative). If there is a potential that the residual risk or its acceptability has changed, the impact on previously implemented risk control measures must be re-evaluated and justified.

The results of this evaluation must be documented.