Module 15 Presentations

10/04/2024

Additional Requirements for high risk devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

41

Implantable and class III devices

ARTICLE 61 The MDR requires confirmation of conformity with GSPRs to be based on clinical data ARTICLE 61.4 The MDR requires clinical investigations to be performed on:

● implantable devices ● class III devices

Additional Guidance:

MDCG 2023-7

with some exceptions….

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

42

21