Medical devices under the European Union Medical Device Regulation (MDR) 2017/745 have remained subject to stringent legal requirements in matters of their approval and market surveillance.
This also gives the possibility of demonstrating a device’s safety and performance by way of claiming equivalence to an existing, legally marketed device to streamline the regulatory encumbrances in using data earlier generated for seeking approval of the new device.
But much effort has to be put into constituting a complex affair of claiming equivalence by comprehensively documenting and analyzing the process.
Equivalence considerations are based on proper scientific justification, and all three characteristics (clinical, technical, biological) must be fulfilled. This means no significant difference in performance and safety would be triggered by differences between the evaluated device and the presumed equivalence device.
This article analyses the general principles for claiming equivalence according to the MDR, directing the manufacturers through this important and critical process.
Identifying an appropriate device for equivalency
According to the guidelines for the claim of equivalency, the most basic and crucial step is to find a proper equivalent device which is legally marketed within the EU.
The device should have comparable technical, biological, and clinical characteristics with the device in question for such evidence to be ideally applied to the device claims. In other words, the manufacturer needs to justify the choice of that equivalent referring to design, intended use, and risk profile.
Collection of Data
The next step once the device has been found to be appropriate as an equivalent device is to collect all the data concerning the new device and equivalent device, corresponding to technical documentation, clinical evidence, and post market performance.
Technical documentation covers specifications, production processes, and composition of the materials. Clinical evidence includes clinical investigations, peer-reviewed literature, and real-world performance.
Post-market surveillance: Adverse Event reports, Data from post-market surveillance include adverse event reports, field safety notifications, and reports from users. Gathering all this extensive data is essential for proper comparison.
Carry Out an In-Depth Comparison
The comprehensive comparison between the new device and equivalently old device forms the basis for the equivalence claim. The comparison involves technical, biological, and clinical dimensions.
PRINCIPLES OF CLAIMING EQUIVALENCE UNDER THE MDR
· The process of claiming equivalency permits another device or devices’ clinical data to enter the clinical evaluation for assessment against the GSPRs. Equivalence does not exempt a device from performing a clinical evaluation. The MDR always requires a clinical evaluation.
· A device can be equivalent to one more device if all the biological, clinical and all technical equivalence requirements can be fulfilled in each of the claimed equivalents. Every claimed equivalent device must be fully investigated, described and demonstrated in the CER (Clinical evaluation report).
· Claiming equivalency by using different parts of different devices is unacceptable.
· The manufacturer must explain any differences and offer a scientific explanation for why there should be no impact on performance or safety.
· Biological and technical differences can be substantiated by preclinical data from the manufacturer’s own device or data from scientific publications.
Any differences must fully demonstrate which there is no discernible clinical impact on either performance or safety; this evaluation must be supported up by clinical data, established technical specifications, common specifications, or harmonized standards, and it must be properly justified. This data must be relevant to the devices under evaluation.
· In order to claim equivalency, modifications are permitted. If safety or performance issues are being addressed by the modifications, the manufacturer should strongly state that no new safety or performance.
· The manufacturer is required to perform PMCF, and more especially post-market studies for class IIb, III and implanted devices, prior to implementing modifications to these devices.
· Pre-Clinical and Clinical data must belong to a definite generation or version of the claimed equivalent device. (MDCG 2020–5 (4) ©
· When equivalence is claimed to a device that relies on clinical data from another earlier generation, the manufacturer must justify very strongly and demonstrate that the cumulative effects of all modification or version upgrades have not reached significance as far as safety and performance are concerned.
· Any minor changes have not in any way seen a device being pushed so far away from the device that originally held the clinical data that the equivalence cannot be claimed in this situation.
· The consideration now should be given to state of the art including whether the original clinical data obtained reflects current clinical practice or current technical capability.
· A manufacturer cannot claim that their device is equivalent to a device without an ancillary medicinal substance or vice versa. A manufacturer will not be able to claim equivalence of the ancillary medicinal substance to a ‘stand-alone’ medicinal substance.
· A manufacturer of a medical device may not claim equivalence to a product not intended for medical purposes listed in the MDR Annex XVI.
CONCLUSION
The European Union Medical Device Regulation (MDR) 2017/745 allows for equivalence claims to already existing, legally marketed devices for the purpose of safety and performance demonstrating.
However, for claiming equivalence, extensive documentation and analysis are required on all three characteristics: clinical, technical, biological. It also needs convincing no new safety or performance issues are being addressed.
Modifications are permitted; justification has to be provided, and state no new issues have been addressed with the changes concerning precise safety or performance. Pre-clinical and clinical data should pertain to a clearly defined generation or edition of the claimed equivalent device.
Modification or version-upgrade accumulation has to be justified, considering state of the art, including whether the original clinical data are representative of current clinical practice or technical capacity. Also, manufacturers cannot state equivalency without an ancillary medicinal substance or vice versa.
AUTHOR
Dr Minu Lazar, BDS (Junior Consultant at I3CGLOBAL)
REFERENCE
1. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE
2. MDCG 2020–5 Clinical Evaluation — Equivalence
3. EU MDR
4. Laura Court, MDCG 2020–5 Explained: How To Demonstrate Equivalency in the EU (2022)
5. Helen Quie, How to use the Equivalence Pathway under MDR