The CE marking system in the European Economic Area and Switzerland relies on a mixture of pre and post market activities. The theory is that no matter how broad and deep the pre-market testing, there is always a residual risk in the use of a medical device. Therefore it is essential that a proper post market surveillance system (PMS) be instituted to follow devices during the marketing phase.

The extent and nature of post market surveillance systems is not prescribed in EU legislation.

Priory Analysts develop pragmatic, yet comprehensive PMS systems.