Module 15 Presentations

10/04/2024

Specific requirements for equivalence: Implantable and Class III devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

29

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 7

30