Vigilance

Vigilance is the reporting part of post-market surveillance. Under the EU MDR, manufacturers report serious incidents and field safety corrective actions to the competent authorities (Article 87), report statistically significant increases in other incidents through trend reporting (Article 88) and investigate what they report (Article 89). The regulation does not define the word itself; it is the title of the section that holds these rules, Articles 87 to 92.

1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88; (b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country. The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92.

EU MDR, Article 87(1)

The US does not use the term vigilance. The comparable FDA rules are Medical Device Reporting under 21 CFR 803 and reports of corrections and removals under 21 CFR 806, and their triggers and deadlines differ from the EU ones.