Medical Device Post Marketing Surveillance

Post market surveillance the key to better devices it s difficult to state that by removing the equivalence rule and replacing it with a more strict clinical trial requirement similar to the pharmaceutical industry we could have safer or more effective devices.

Medical device post marketing surveillance.

Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post approval studies required at the time of approval of a premarket approval. Effective post market surveillance for medical devices post market surveillance pms is defined as a systematic process to derive necessary corrective and preventive actions capa from information on medical devices that are already placed on the market. In order to comply with the european union eu medical device directives 90 385 eec active implantable medical directives aimd 93 42 eec medical device directive mdd and 98 79 ec in vitro diagnostics device directive ivdd referred to as the directives hereafter manufacturers must conduct post market surveillance pms. It has focused on collating and reporting adverse events such as device malfunctions or patient injuries in order to trigger product returns modifications exchanges and recalls as necessary.

The fda adverse event reporting system faers is a computerized information database designed to support the fda s post marketing safety surveillance program for all approved drug and therapeutic. The historical role of post market surveillance pms of medical devices has been reactive. And post market phases. Post marketing surveillance for medical device post marketing surveillance pms is the practice of monitoring the safety of a medical device after it has been released on the market.

Post market surveillance pms is an important part of the regulatory framework for medical devices in europe. The medical device regulation mdr lays special emphasis on gathering clinical and safety related data after the approval ce certification process and market access. Figure 3 risk managements documents required for the market placement of a medical device compared with a.