Module 15 Presentations

10/04/2024

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 7

31

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 complies 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 7

32