Module 15 2022

19/05/2022

Key concepts to equivalence

MDR Annex XIV Part A section 3 (continued) • ‘Same’ infers identical • ‘Similar’ which applies to the Technical Characteristics means:

The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

9

Key concepts to equivalence

MDR Annex XIV Part A section 3 (continued) • Access to data:

• […] It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

10

5