There are many ways to collect these real-world post-market data, and it is vital to be able to justify which approach(es) is optimal for a given medical device. There are 2 aspects to consider:
- clinical evidence requirements, i.e., clinical gaps identified in the CER and risk classification
- feasibility of implementation, i.e., cost and timelines
PMCF Surveys offer a compliant, simple, timely and cost-effective means of RWD collection, especially for well-established technologies with lower risks of clinical gap exposure.