Clinical trial phases for medical devices

There are four different phases of a clinical trial for medical devices. Clinical trials are also referred to as clinical studies.

Clinical trial phases are very important because they enable researchers to properly assess the safety and effectiveness of new treatments and devices before being approved for use by the general public.

Find out more about clinical trial phases for medications and treatments.

Find out more about what happens in each phase below.

Pilot / Early feasibility / First-in-human

10 - 30 participants

Purpose of this phase

  • Small study to collect preliminary safety and device performance data in humans
  • Guides device modifications and future study design
Traditional feasibility

20 - 30 participants

Purpose of this phase

  • Assess safety and effectiveness of the near-final or final device design in patients
  • Guides the design of the next phase
Pivotal

100s of participants

Purpose of this phase

  • Large study to confirm clinical effectiveness, safety and risks
  • Statistically driven
Post-market

1000s of participants

Purpose of this phase

  • Monitors the long term effectiveness, safety and usage of the device in the general population