Post-market surveillance (PMS) will be the next big challenge in the medical device industry in Europe. The Medical Device Regulation defines requirements for planning and reporting of PMS activities and mentions a list of information that must be provided in the PMS Report (class I devices) and Periodic Safety Update Report (“PSUR”, for class IIa, IIb and III devices). The new MDCG guidance for the PSUR includes additional requirements for content and structure of the Report. And these requirements apply to all medical devices currently on the market, not just to devices with already existing MDR compliance.

What the MDCG guidance highlights: Input data from several other processes must be compiled, analyzed and presented in a clear and consistent manner. And this can only be implemented efficiently if the interfaces between all processes are clearly defined and necessary attributes of individual data sets are documented.

Every manual step and “media break” between different databases and document formats increases the time needed to create PSURs and is a risk for inconsistencies. It is therefore inevitable to digitalize and integrate all PMS-related processes in the long term in order to manage the complexity of sources and different data sets.

This Tech-Talk addresses the following questions: 

• What requirements of the PSUR MDCG guidance are new?
• What are the implications for other processes in the QMS?
• What is important for integration of these interface processes?
• Which sections of the PSUR could be created automatically?