Module 15 Presentations

10/04/2024

Key concepts to equivalence MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence • Provides additional clarification on the application of Articles 61(4), (5), and (6) • Provides additional clarification on ‘sufficient levels of access to data’ • In general: • Class I, IIa, IIb (non-implantable) - a contract with the equivalent device manufacturer is not required. Access to the IFU, other technical documentation and/or the results of bench testing may suffice. • Class III and implantable – a contract is required*

*MDCG 2023-7 presents the case where equivalence is claimed with devices from more than one manufacturer, a contract is only required with one of them.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

11

Key concepts to equivalence

The Frankenstein approach is not acceptable • MDR Annex XIV Part A section 3

[…] a device […] […] the device.

MDCG 2020-5 clarifies “each device shall be equivalent to the device under evaluation in all the listed technical, biological and clinical characteristic”*

•

*Limited exception for device ‘systems’, but from same manufacturer

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

12