This post-CE marking clinical follow-up consists of collecting real-life clinical data to confirm the medical device performance and safety claims.
This step is complex and the data it generates must be ethically and scientifically valid, reliable and robust, in order to maintain the device on the market.
Medical device manufacturers must conduct PMCF studies to gather additional information on a product already CE marked, unless there is a medico-scientific justification. A PMCF strategy outlined in the Post-Market Surveillance plan is essential to maintain compliance under the MDR.
It is crucial that manufacturers update clinical data available on the medical device to assess the benefit/risk ratio throughout the life of the product.
The Eclevar teams can help you within the PMCF framework, with a global or customized offer, tailored to your challenges.
The importance of entrusting the responsibilities of managing clinical investigations to knowledgeable and experienced individuals cannot be overstated.
Studies are complex and the data they generate must be ethically and scientifically valid, reliable and robust.