Module 15 2022

19/05/2022

Implantable and Class III devices

MDR Article 61(4) • Implantable and Class III devices are exempt from clinical investigations if: • The device has been designed my modifications to a device already marketed by the same manufacturer • The modified device has been demonstrated to be EQUIVALENT to the marketed device • The clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device • PMCF will be required to collect clinical data for the modified device

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

29

Implantable and Class III devices

MDR Article 61(5) • Implantable and Class III devices are exempt from clinical investigations if: • The manufacture can demonstrate equivalence with a device not manufactured by him on the basis o The manufactures have a contract in place explicitly allowing the manufacture of the second device full access to the technical documentation of the equivalent device on an ongoing basis o The original clinical evaluation has been performed in compliance with the MDR

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

30

15