The breast and hip implant scandals resulted in a flood of lawsuits against medical device manufacturers, governments facing cost related to device replacements, but also in enhanced attention to the proposed changes on the Medical Device Directives and to postmarket surveillance.
More and more postmarket surveillance is handled through postmarket clinical trials. However, the concerning European regulatory landscape for such medical device studies – that to me includes registries -, is an enormous tangle of standards, guidances, directives, and regulations. This can easily lead to unintended inconsistencies in recording and reporting of adverse events. Especially when multiple sites in different countries are participating in a postmarket trial, safety reporting can become very challenging.
These Postmarket Trial AE reporting slides can help guide through this tangle.
The three key points to take into account:
1. National legislation should be followed – verify current local National Competent Authority and Ethics Committee requirements
2. The study sponsor has overall responsibility for adequate safety reporting – ensure external as well as internal alignment regarding adverse event and incident recording and reporting
3. The study protocol is the core document for any trial – include adverse event definitions and reporting processes to be followed, so that all involved are aware.
Please feel free to contact me in case you want to exchange thoughts regarding the above or otherwise.