Module 15 Presentations

10/04/2024

Implantable and Class III devices

MDR Article 61(6)(b) • Implantable and Class III devices are exempt from clinical investigations if: • The devices are 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 (this can include EQUIVALENCY and PMCF data) • The device complies with the relevant product-specific CS, where such a CS is available

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

33

Specific requirements for equivalence: Non-implantable and non-Class III devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

34