Can an investigator-initiated study qualify as a PMCF study under MDR?

Anonymous · Published December 15, 2025 · 1 comment

During our ongoing MDR certification process, we have been asked to provide information on a planned Post-Market Clinical Follow-up (PMCF) study. One of our customers, a clinic, is planning to conduct an investigator-initiated study using our product, and the study outline matches what we would have planned. Would this study qualify as a PMCF study if it is not initiated by us, but by the clinic? If so, under what conditions could we use this study as part of our PMCF activities?

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Anonymous 6 months ago

Does the clinic's study address your specific PMCF objectives and endpoints? Do you have access to the data?

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory · 6 months ago

My understanding is that if you are aware of the study and the endpoints match your PMCF objectives, and you have access to the relevant data, you can include the planned investigator-initiated study in your PMCF plan as a source of data. However, it's important to make sure the study is designed to address the specific issues identified in your clinical evaluation. If you are collaborating (even informally) and the study design fits your needs, you should be able to use it for PMCF purposes.

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