Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence
The following is the first in the series of blogs related to the recent updates to EU MDR. Read the 2nd post about the new EU MDR rules and their impact on technical files. You can view the 3rd post about post the new post market clinical follow up requirements for EU MDR.
How to Demonstrate Equivalence Between Medical Devices – EU MDR
Recent updates to the European Union Medical Device Regulations (MDR) brings about a very important topic for the medical device industry – how to adequately demonstrate equivalence between the device under evaluation and a similar, currently marketed device.
When a medical device Premarket Notification (510k) is filed with the U.S Food and Drug Administration (FDA), the goal is for the agency to determine that the device under evaluation is substantially equivalent to a legally marketed (predicate) device. This substantial equivalence finding conveys that the new device is at least as safe and effective as the predicate device. The new device is then cleared to be legally marketed and is bound to the same classification and regulatory requirements as the predicate device. The message to the public is that the FDA does not have any concerns related to the new device’s safety or effectiveness.
CE Marking Process for Medical Devices – EU MDR
Recently, the CE Marking process for medical devices has incorporated a similar but more strict approach to demonstrating equivalence between medical devices. As you may know, the regulatory submission for a medical device to achieve the CE Mark is a compilation of technical documentation focused on the device under evaluation and does not incorporate a mandatory comparison to any current CE Marked device. It is evaluated as a stand-alone submission. However, a demonstration of equivalence to a medical device with a current CE Mark may be used (optionally) to satisfy one aspect of the regulatory submission – the clinical data requirement. The Revision 4 update to MEDDEV 2.7/1 includes very specific and more strict requirements for a demonstration of equivalence, as compared to the requirements by FDA to support a finding of substantial equivalence.
The below tables summarize the differences in the way the FDA and the European Commission evaluate the clinical, technical and biological characteristics when comparing the device under evaluation and the proposed equivalent device.
Substantial Equivalence vs. Demonstration of Equivalence
For many companies, it is a challenge just to find adequate regulatory resources to compile this exhaustive list of medical device characteristics for both the device under evaluation and the proposed equivalent device. An adequate demonstration of medical device equivalency that meets the requirements of the regulations and passes review by your notified body or the FDA will require a substantial investment of both time and specialized expertise.