Infographics
A one-page decision flowchart for choosing a defensible PMCF method under EU MDR
The December 2025 MDR proposal removes the separate PMCF evaluation report for Class III and implantable devices. It does not remove the Annex XIV Part B Section 5 duty to proactively collect clinical data across the device lifetime. Less paperwork, same data. This one-page flowchart takes you from the evidence gap to a defensible PMCF method, whether surveys, registries and prospective studies, or retrospective collection under a protocol, each justified under Section 6.2(c). Download the flowchart and its companion one-pager to:
Thinking past your pilot, to market and post-market?
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