Qualification of Merchandise underneath the MDR

Qualifying merchandise as per Annex XVI, lined by the CS, includes completely inspecting the product’s attributes, capabilities, and supposed utilization.

The MDR categorizes merchandise primarily based on standards outlined in Articles 1(1) and 1(2), distinguishing between medical gadgets, equipment, and Annex XVI merchandise.
This distinction is essential because it determines the regulatory pathway {that a} product should comply with.

The MDR doesn’t present express definitions for Annex XVI merchandise, thus requiring a cautious interpretation of the product descriptions in Annex XVI and the scope sections of the CS.

The traits comparable to the kind of product, know-how used, functioning modalities, goal physique half, organ or tissue, and the supposed goal are all thought of in the course of the qualification course of. Moreover, the steerage emphasizes the significance of aligning with the state-of-the-art and current harmonized requirements for analogous gadgets with a medical goal.