System and plan
Post-market surveillance, which is described in Articles 83 and 84, aims to produce information on the safety and performance of the device through the device’s entire life span. Post-market surveillance is an inseparable part of the manufacturer’s quality control system. In addition to reactive data gathering regarding e.g. incident reports and customer feedback, the manufacturer has to proactively collect information about the devices it manufactures and similar, comparable devices.
The manufacturer utilises the results of data gathered in post-market surveillance to update device documents, such as clinical assessments, benefit-risk ratios and user instructions. The Annex III of the Regulation regarding technical documents in post-market surveillance determines that the following information content must be collected.
The manufacturer has to define:
- information sources, e.g. which literature sources, databases and registers are used
- methods of data collection
- analysis methods of the gathered data
- threshold values requiring action
On the basis of collected and analysed data, the manufacturer prepares a post-market surveillance report on class I devices (Article 85) and a periodic safety update report on class IIa, IIb and III devices (Article 86).