Medical Device Post Marketing Surveillance

Post market surveillance pms is an important part of the regulatory framework for medical devices in europe.

Medical device post marketing surveillance. 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. The historical role of post market surveillance pms of medical devices has been reactive. And post market phases. The medical device regulation mdr lays special emphasis on gathering clinical and safety related data after the approval ce certification process and market access.

Eu postmarket surveillance plans for medical devices pdf. Post marketing surveillance guidelines is a collection of processes activities used to monitor the safety effectiveness of medical devices. 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. 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.

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. Postmarketing surveillance pms also post market surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Figure 3 risk managements documents required for the market placement of a medical device compared with a.