What is PMCF translation?

PMCF translation is the specialised translation of post-market clinical follow-up documentation, including PMCF plans, PMCF evaluation reports, surveys, registry inputs and clinical follow-up data, into target languages required by the markets where a medical device is placed. Under the MDR, PMCF activities support ongoing clinical evidence throughout the device lifecycle and feed CER updates. Translations must accurately reflect approved source content, with controlled clinical terminology and consistency with surrounding regulatory documentation. AbroadLink delivers PMCF translation with qualified medical linguists, ISO-based processes and risk-based workflow selection tailored to device class and document type.