The post market clinical follow-up (PMCF) template illustrates a guideline of the PMCF procedure including all the key requirements. The manufacturer is responsible to develop a continuously updated PMCF plan and report in order to place a device on the market. Hence, this template was designed to give guidelines to the manufacturer in order to produce a successful PMCF plan and report which meets the regulation MDR 2017/745. The PMCF template is provided with descriptions and examples for all the requirements needed.
Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.
Our consultants are available, should you need further assistance in completing the documentation.