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The group was tasked with producing a framework document aimed at manufacturers and notified bodies to cover best practice in:
pre-market clinical evaluation of current and planned devices, including advice on pre-market clinical trial design
post-market clinical evaluation of current and planned devices and evaluation of data gathered in the post-market phase.
This guidance applies to new devices and all design changes or iterations and enhancements that might affect the clinical safety or performance of the leadless device. It provides advice on general statistical principles which can guide decisions in designing and conducting the study.
Minor changes to reflect clinical experience gained over the last year, including: operator experience and implant surveillance; additional recommended minimum sample sizes and follow-up durations; recommendations on implanting centre selection.