The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased need for pre-market clinical investigations for certain higher risk devices to verify their safety and clinical performance. These increased clinical evidence requirements present a challenge for devices specifically intended for use in rare diseases/conditions, or in specific indications for rare cohorts of patients with an otherwise non-rare disease/condition.
By their nature, these ‘orphan devices’ are only intended for use in a small number of individuals each year. Many rare diseases have very few diagnostic or therapeutic options and the orphan device can be particularly crucial to fulfil an otherwise unmet medical need. In the absence of specific guidance for these devices, different understandings can emerge among manufacturers, notified bodies, and regulators on the clinical evidence requirements for these devices for the purposes of MDR certification…
