Description: The first presentation will discuss the increased expectations under the MDR for both Post-Market Surveillance (PMS), and the increased scope of post-market clinical follow-up (PMCF). The relationship between PMCF and the Periodic Safety Update Report (PSUR) detailed in Article 86 of the MDR will be considered. Pragmatic approaches to addressing the PMCF requirements of the MDR will be discussed, proposing appropriate solutions to address the new requirements, consistent with the risk of the device; the relative merits of differing approaches will be reviewed. The second presentation will provide further depth and practical insight into various options for meeting the new PMCF requirements. Depending upon the purpose of PMCF, the options available range from a formal PMCF investigation, investigator-initiated studies, registries, patient or investigators’ questionnaires, and other methods. Other aspects that will be discussed include the type of clinical data that need to be collected, complexity of the various study options, data collection methodologies, data quality aspects and country-specific considerations relevant to data protection issues.
Upon completion, participant will be able to describe the key changes in post market expectations of the new EU MDR, particularly in relation to PMCF
Upon completion, participant will be able to describe the difference between a full PMCF investigation and other types of PMCF activities
Upon completion, participant will be able to describe the practical aspects of managing the various PMCF activities
Upon completion, participant will be able to define and plan PMCF strategies appropriate to their device(s) to ensure continued compliance with MDR requirements