Post market surveillance in the german medical device sector - current state and future perspectives

- As the use of medical devices can lead to high risks for patient safety, manufacturers have to evaluate and monitor the device performance in the post market phase.
- In anticipation of the new EU medical device regulation, we provide empirical insights into current post market activities of German medical devices manufacturers.
- Manufacturers use a variety of post market instruments, esp. internal knowledge sources.
- Significant differences in the intensity of use were found between the manufacturers, esp. with respect to the medical device risk class.

Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues.