Module 15 2022

19/05/2022

Implantable and Class III devices

MDR Article 61(6)(a) • Implantable and Class III devices are exempt from clinical investigations if: • They have been placed on the market and put into service under the MDD/AIMDD (legacy device as per MDCG 2020-6) • The clinical evaluation is based on sufficient clinical data (this can include EQUIVALENCY and PMCF data) • The device is in compliance with the relevant product specific Common Specification for the clinical evaluation of that kind of device (where available)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

31

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 is in compliance with the relevant product-specific CS, where such a CS is available

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

32

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