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Post-Market Clinical Follow-up (PMCF) plan

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The documented, proactive, organized methods and procedures set up by the manufacturer to collect clinical data based on the use of a CE-marked device corresponding to a particular design dossier or on the use of a group of medical devices belonging to the same subcategory or generic device group as defined in Directive 93/42/EEC. The objective is to confirm clinical performance and safety throughout the expected lifetime of the medical device, the acceptability of identified risks and to detect emerging risks on the basis of factual evidence. 

Other glossary definitions



Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or…

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Incident for Medical Device (MEDDEV definition)

Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due…

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