Confused about Sufficient Clinical Data as per MDR Article 61
- clinical investigations of the device under evaluation
- clinical investigation or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.
Question 01: Are the devices include sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data can any one help me understand what is Sufficient Clinical Data
Question 02: If the product not coming under point 1.7 and the clinical data not deemed to require for the demonstration of conformity with the GSPR, then is there adequate justification in any sort to be provided?