International Clinical Evidence Professional Society, the global leader in the development of innovative approaches to evidence harmonization for medical devices and in-vitro diagnostics.
Dear Medical Device Clinical Community,
Many of you may wonder why our working group is active again when we have just published the 2026 update. There are several reasons. Because the 2026 edition contains important guidance on risk management, we needed to get this out for application and decided to put aside several other points for further updating our standard. So what are these other points?
First of all, we had comments on the FDIS in 2025 that were technical. As an FDIS can only accept editorial comments, we decided to address these technical comments in the update.
Further topics to cover are the new gaps with ICH E6(R3). It has always been our policy not to reinvent GCP but to adapt it for medical devices. Therefore, it is of utmost importance that we look at any updates our pharma colleagues make so that we align as much as we can to avoid confusion for the users of our documents who conduct both drug and device studies. This is especially important for professionals who work with drug-device combination products, but also for physicians and research teams who conduct both pharma studies and device clinical investigations.
We also want to provide further guidance on study designs for the different phases: pilot, pivotal and post-market, and refine our Annex A on CIP content, especially by clarifying instances where we mention ‘if applicable’.
More points may come up as we move forward with this new work item. It takes time to update a standard and therefore, given the topics at stake, we do not want to waste time while our community is using the 2026 version and collecting feedback from experience.