Post-market surveillance refers to all measures taken by the manufacturers in cooperation with other economy operators that predictively, systemically and in a timely manner collect and examine experiences on devices placed, made available or taken into use on the market in order to see whether it is necessary to carry out immediately required corrective or preventive measures (Article 2, Section 60).
In post-market surveillance, the collected information is fed into the risk management system and post-market clinical surveillance and vice versa.
The Commission is in the process of drafting instructions on post-market surveillance. In addition, the standard Medical devices – Post-market surveillance for manufacturer ISO/TR 20416:2020 can be utilised in establishing a surveillance system.
The post-market surveillance system shall be based on the post-market surveillance plan. See more information under: System and plan.
The analysis and conclusions of the data collected as a result of the post-market surveillance plan are reported, depending on the device class, in either a post-market surveillance report (class I devices) or a periodic safety review (class II a, II b and III devices). See more information under: Reports to be prepared.