In light of the New Legislative Framework alignment package directives, a product is considered non compliant if the technical file is missing or incomplete (this is called ‘Formal Non Compliance’). This means that for the enforcing authorities it will become easier to determine non compliance. This is a factor that you will have to take into consideration when managing your products as it will have a direct impact on your product risk strategy. Managing risks is all about looking at the probability of something versus the impact or effect that the occurrence will have. Well, with this so called Formal Non Compliance, the chance that your products will be reviewed by the authorities will increase significantly. And we all know that such an occurrence can be quite impact full, resulting in fines, product recalls and damage to your brand.