MHRA Issues Guidance on Leadless Pacemaker Clinical Studies
The UK’s medical device regulator issued new guidance on the design of pre- and postmarket clinical studies for leadless pacemakers, including patient selection, sampling, and adverse event monitoring.
The Medicines & Healthcare Products Regulatory Agency (MHRA) says manufacturers should work to minimize bias and make inherent design limitations explicit – and statistical assumptions should be agreed to in advance with regulators and not be altered without approval.
Premarket studies should be supplemented by postmarket studies or registries to evaluate longer-term safety and performance, MHRA says. The guidance also says postmarket study and registry requirements should be based on what was learned during premarket evaluation.
Patients who take part in both pre- and postmarket studies should be representative of those who will be treated in clinical practice. Clinical indications for which a pacemaker is approved must be based on evidence gained from equivalent patients included in the premarket study.