Post-market clinical follow-up

Post-market clinical follow-up is the proactive part of a device manufacturer's post-market surveillance: the continuous collection of clinical data on a CE-marked device throughout its lifetime, carried out through a plan that states how the data will be collected and an evaluation report that presents and evaluates the results. The parts divide by what a writer has to settle: where the follow-up sits within surveillance, the plan, the methods the plan chooses between, the report, and the alignment those documents owe the rest of the technical documentation. The clinical evaluation the follow-up updates is left to clinical evaluation of medical devices, the plan and report of a clinical investigation to clinical investigations of medical devices, the periodic safety update report to periodic safety update and post-market surveillance reports for devices, and real-world evidence to real-world evidence for medical devices.

• Post-market clinical follow-up within post-market surveillance — what PMCF is and how MEDDEV 2.12/2 and the MDR define it, proactive surveillance beside the reactive vigilance system and the different clocks they run on, what changed from the directive to the regulation, the sources of proactive data from the literature and bought health-record data sets to social media listening, and the off-label use it aims to identify
• Writing the PMCF plan — when a plan is needed and where it sits among the device's documents, the aims and required contents set by Annex XIV Part B, general and specific methods and how they are chosen and justified, the objectives and detail a plan needs, the MDCG plan template, the departments that contribute, and consulting the notified body
• PMCF studies and registries — when a PMCF study is indicated, its objectives and investigation plan, the four designs, extending the follow-up of a pre-market investigation, starting a study before the CE mark, manufacturer-initiated and public registries and those of well-established prostheses, and the extended indication that needs a new clinical investigation instead
• PMCF user surveys — choosing a survey, its place in the hierarchy of clinical evidence and when a clinical study suits a device better, designing it from the stages and feasibility through the protocol and endpoints to the sample size and each question, and running it from programming and ethics review to analysis and the next round
• Writing the PMCF evaluation report — what the report is, the seven sections of the MDCG report template, the critical analysis of the results, the conclusion and the further activities it states, and the causes of a late report, from ethics approval to a wrongly chosen design and underestimated recruitment
• Keeping the PMCF documents aligned with the rest of the file — how much the PMCF documents repeat of the clinical evaluation report and how much detail the report gives, the revision cycle set by the clinical evaluation report and the device class, and the chain of updates a PMCF finding sets off through the other post-market documents to the periodic safety update report