Module 15 2022

19/05/2022

Key concepts to equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

3

Key concepts to equivalence

• MDR Article 61 requires the manufacturer to carry out a clinical evaluation as part of the conformity process • Article 61(3) allows the clinical evaluation to be based on data from an equivalent device • Clinical data from one device is used to justify the clinical performance of another • Using clinical data from an equivalent device may reduce the need to carryout a clinical investigation, saving time and money • It is particularly useful when the device has been designed by modification to a device already marketed • There must be sufficient clinical data for the equivalent device: an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions [MEDDEV 2.7/1] • It does not negate the requirement to collect data on the actual device. However, it may reduce the needed to collect data prior to CE certification and allow the data to be collected post-market as part of the PMCF plan

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

4

2