MDCG 2020-5 Gives Unequivocal Guidance on Medical Device Equivalence Under the EU MDR
If your medical device clinical evaluation relies on a comparison to an “equivalent” device, you may be wondering if your Notified Body would view your analysis as a true “apples to apples” comparison. Although the word “equivalent” seems clear, few words have created more angst in the context of EU Medical Device Regulation (EU MDR). What exactly does “equivalent” mean? Does it mean “exactly the same” or more like “very similar”? The answer depends on whom you ask. But before we debate that, let’s rewind for a moment.
In June 2016, MEDDEV 2.7-1 rev 4 on clinical evaluation for medical devices was released. It was followed shortly thereafter by the EU MDR in May 2017. Both the MEDDEV and EU MDR address the issue of device equivalence, but the problem is that they were not “equivalent” in their interpretation of the topic. MDCG 2020-5 aims to settle the issue by comparing and resolving conflicting parts of the Regulation and Guidance. Let’s dig in.
Differences Between MEDDEV 2.7-1 rev 4 and the EU MDR When It Comes to Medical Device Equivalence
Same or similar? Here’s one example of the conflict between EU MDR and the MEDDEV 2.7-1 rev 4 guidance. The MEDDEV states that the device must be “of similar design and used under the same conditions of use…” while Annex XIV, Part A(3) of the EU MDR says “…used under similar conditions of use.” Section 3.1 of MDCG 2020-5 clears this up by saying that devices “shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance between the device in question and the device presumed to be equivalent.”
Software algorithms. The MEDDEV does not even address similarities in software algorithms, but the EU MDR does. The writers of MDCG 2020-5 smartly recognized that demanding equivalency in software code was pointless. Instead, section 3.1 states that “It is the functional principle of the software algorithm, as well as the clinical performance(s) and intended purpose(s) of the software algorithm, that shall be considered when demonstrating the equivalence of a software algorithm.” Software without a medical purpose (example: to drive a graphical user interface) do not need to be similar. See section 3.3 of MDCG 2019-11 for more information on this.
Biological characteristics. Both the EU MDR and the MEDDEV state that the equivalent device must “use the same materials or substances in contact with the same human tissues or body fluids….” However, the EU MDR expands on this statement by adding: “…for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.” Manufacturers need to take these factors into account because, as the guidance states, “…processing, design and the use environment may introduce small changes even when the raw materials are the same.” Any substances introduced into the human body must be the same, however.
Clinical characteristics. Annex XIV, Part A(3) of the EU MDR requires the equivalent device to be “used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.”
There are two points to be made here. The first is that although the EU MDR does not state that the device needs to be used for the same medical indication, gender, and duration of use, it does say that both devices need to be used for the same clinical condition or purpose. This includes severity and stage of disease.
The second point is that the EU MDR clearly indicates that the equivalent device must be used by the same kind of user. MEDDEV 2.7-1 rev 4, by contrast, indicates that the device can be used in similar populations, citing age, gender, anatomy, physiology, and other aspects. The EU MDR broadens the scope of comparison in that it requires manufacturers to take user competence and knowledge into account.
Demonstrating Medical Device Equivalence Under the EU MDR
Again, the EU MDR narrows a slightly broader definition of equivalence contained in Appendix A1 of MEDDEV 2.7.1 rev 4. The EU MDR states, “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.”
Some will also be pleased to know that MDCG 2020-5 makes clear that more than one device can be used in your comparison. However, before you get too excited, it is not acceptable to use different parts of different devices to claim equivalence. See section 4(b) for more information on this, as there are some exceptions to this rule. It seems obvious, but the guidance also points out that preclinical and other clinical data must relate to a defined generation/version of the device under consideration for equivalence.
Finally, Annex I of the MDCG 2020-5 guidance makes a point of saying that manufacturers should emphasize the differences between the two devices rather than the similarities, and that in all cases scientific justifications should be provided when claiming there is no clinically significant difference between your device and the device you are using for comparison. We recommend that you read Annex A6 of MEDDEV 2.7-1 rev 4 for more information on appraising clinical data.
When in Doubt, the EU MDR Takes Precedent
Annex 1 of MDCG 2020-5 provides a useful equivalence table template you can copy into Word or Excel. While it does not contain all factors you must consider when performing a clinical equivalence comparison, it’s a great head start.
MDCG 2020-5 is intended to clear up confusion caused by discrepancies between the European Medical Device Regulation (2017/745) and MEDDEV 2.7-1 rev 4. But remember: When a conflict of interpretation occurs between MEDDEV 2.7-1 rev 4, MDCG 2020-5, and the EU MDR, the latter always takes precedent and is legally binding.
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