MDCG 2020-5: How to Demonstrate Equivalence Under EU MDR
For manufacturers using clinical data from another device to support their clinical evaluation, equivalence under the EU Medical Device Regulation (MDR) is a demanding evidential claim, not simply a statement that two devices are similar.
MDCG 2020-5 explains how the MDR equivalence requirements should be applied in practice. It is particularly important for manufacturers carrying forward equivalence strategies developed under the Medical Devices Directive (MDD), and for Class III and implantable devices where equivalence is being used as part of a strategy to avoid a new clinical investigation.
MDCG 2020-5 at a Glance
Authority
MDCG guidance, non-legally binding
Publication
April 2020
Current Status
Current MDCG guidance
Read Alongside
MDR Article 61 and Annex XIV Part A; MDCG 2023-7
The Headline
MDCG 2020-5 substantially raises the evidential discipline required to demonstrate equivalence under the MDR.
A manufacturer must demonstrate equivalence across technical, biological and clinical characteristics and show that any differences would not result in a clinically significant difference in safety or clinical performance. The assessment must be scientifically justified and supported by sufficient access to the data needed to make the comparison.
For Class III and implantable devices, there is an additional issue where a manufacturer wants to rely on equivalence to a device made by another manufacturer in order not to perform the clinical investigation normally required by Article 61(4). Article 61(5) requires a contract giving ongoing full access to the equivalent device's technical documentation, together with other conditions.
That distinction matters. MDCG 2020-5 has not made equivalence impossible, but it has made weak, assumption-based or poorly evidenced equivalence strategies much harder to defend.
What You Need to Know
Equivalence has three dimensions.
Technical, biological and clinical characteristics must all be assessed. A general argument that two devices are broadly similar is not sufficient.
Some characteristics must be the same; others may be similar.
For example, the MDR requires the same materials or substances in contact with the same human tissues or body fluids, while allowing similarity for some other biological characteristics. Clinically, devices must be used for the same clinical condition or purpose and at the same site in the body, but the relevant patient population and critical performance may be similar rather than identical.
More than one equivalent device can be identified.
However, each presumed equivalent device must independently satisfy the equivalence requirements. Manufacturers cannot construct a composite equivalent device by taking the technical characteristics from one comparator, biological characteristics from another and clinical characteristics from a third.
Differences must be actively assessed.
The question is not simply whether two devices share characteristics. Manufacturers need to identify their differences, determine whether those differences could affect safety or clinical performance, and provide scientific justification for the conclusion.
Access to comparator data matters.
Annex XIV requires manufacturers to have sufficient access to the data relating to a device for which equivalence is claimed. The level of access needed depends on the circumstances and on whether the available information is sufficient to demonstrate the relevant technical, biological and clinical characteristics.
Class III and implantable devices have additional requirements.
Where a manufacturer relies on a device made by another manufacturer to use the Article 61(4) exemption from clinical investigation, Article 61(5) requires a contractual arrangement providing ongoing full access to the technical documentation. This is a more specific requirement than the general requirement for sufficient access to equivalence data.
Does This Apply to Your Device?
MDCG 2020-5 is directly relevant where clinical data relating to another device is being used on the basis that the other device is equivalent to the device under evaluation.
It deserves particular attention if:
your CER relies materially on clinical data from an equivalent device;
the equivalence argument originated under the MDD or AIMDD and has been carried forward into MDR documentation;
the presumed equivalent device is manufactured by another company;
equivalence is being used to support an exemption from clinical investigation for a Class III or implantable device;
the comparator, its intended purpose, design, materials or regulatory status have changed since equivalence was originally established; or
your existing equivalence assessment does not clearly address the MDR technical, biological and clinical characteristics individually.
If your clinical evaluation does not make an equivalence claim and is supported entirely through clinical data applicable to your own device and other appropriate evidence, MDCG 2020-5 will not be central to the evidence strategy.
It may still be relevant, however, when determining whether literature concerning another device can legitimately be treated as clinical data for the device under evaluation rather than as contextual or state-of-the-art evidence.
Unsure whether your existing equivalence strategy would still stand up under MDR?
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What it Means Commercially
The commercial significance of equivalence is easy to underestimate because the problem can remain hidden until relatively late in an MDR programme.
A manufacturer may have a long-standing CER containing substantial published evidence relating to a competitor device. Under the MDD, that evidence may have formed an accepted part of the clinical argument. Under the MDR, the first question is more fundamental: can equivalence actually be demonstrated to the required standard?
If it cannot, the literature itself does not necessarily disappear from the clinical evaluation. It may still contribute to understanding the state-of-the-art, alternative treatment options, known safety outcomes or clinical benchmarks. What changes is the extent to which clinical data from that device can be treated as clinical evidence for the manufacturer's own device.
For some manufacturers, that can materially change the evidence strategy.
The consequence is not automatically that a new clinical investigation is required. The manufacturer may already possess sufficient direct clinical data for its own device, or other evidence may support the clinical evaluation. But where equivalence was doing substantial evidential work, losing it can expose a clinical evidence gap that requires additional data generation, PMCF activity or, depending on the device and circumstances, a clinical investigation.
Identifying that problem early creates options. Discovering it during notified body review creates time pressure.
What it Means for Your Clinical Evaluation
A defensible equivalence assessment needs to deal with the three MDR characteristic groups explicitly.
Technical Characteristics
The comparison should consider factors including device design, conditions of use, specifications and properties, deployment methods where relevant, principles of operation and critical performance requirements.
The characteristics do not necessarily have to be identical. The manufacturer must determine whether any differences could result in a clinically significant difference in safety or clinical performance.
Biological Characteristics
The biological comparison includes the materials or substances that come into contact with human tissues or body fluids, the tissues or fluids concerned, the type and duration of contact, and the release characteristics of substances including degradation products and leachables.
This is an area in which apparently small changes can be important. Similar device function does not establish biological equivalence.
Clinical Characteristics
The clinical comparison considers the clinical condition or purpose, severity and stage of disease, anatomical site, patient population, user and relevant critical performance in view of the intended clinical effect.
MDCG 2020-5 does not simply require every clinical attribute to be identical. The MDR itself uses a mixture of "same" and "similar" requirements. The assessment therefore needs to follow the individual criteria rather than applying a blanket test of identical intended use.
The Overall Equivalence Conclusion
All three characteristic groups must be fulfilled.
Where differences exist, they must be identified and scientifically justified. MDCG 2020-5 specifically directs attention towards differences rather than simply documenting similarities, including the possible cumulative effect of several individually small differences.
Manufacturers may identify more than one presumed equivalent device, but equivalence must be demonstrated independently for each. Data from different devices cannot be combined to create a hypothetical comparator that satisfies the criteria only when its characteristics are assembled from several products.
Where Manufacturers Commonly Get this Wrong
Carrying forward an old equivalence assessment
One of the most common problems is equivalence drift. A comparator chosen several years ago continues to appear in successive CER updates even though its design, intended purpose, regulatory status or available evidence has changed. Meanwhile, the device under evaluation may also have undergone modifications.
An equivalence conclusion is therefore not something that should simply be inherited from the previous CER. It needs to remain valid against the current characteristics of both devices.
Focusing on similarities rather than differences
Equivalence tables can easily become lists of reasons why two devices look alike: That is not enough.
The important regulatory question is whether identified differences, individually or cumulatively, could result in clinically significant differences in safety or clinical performance.
A strong equivalence assessment makes those differences visible and then resolves them scientifically.
Building equivalence from several comparator devices
MDCG 2020-5 permits manufacturers to assess more than one presumed equivalent device.
What it does not permit is a "pick and mix" argument in which one comparator supplies the technical match, another the biological match and another the clinical match. Each claimed equivalent device must independently meet the equivalence criteria.
Assuming published information always provides enough access
Published literature, instructions for use, regulatory summaries and other public information may provide valuable evidence. They do not automatically provide enough information to establish every technical, biological and clinical characteristic needed for equivalence.
MDCG 2023-7 subsequently developed this point further by setting out examples of different levels of access to equivalence data and the limitations that may arise.
For Class III and implantable devices relying on Article 61(5), the position is more prescriptive: the contractual full-access requirement applies where equivalence to another manufacturer's device is being used to avoid the clinical investigation required by Article 61(4).
Treating notified body acceptance under MDD as evidence of MDR acceptability
Previous acceptance is useful regulatory history, but it is not evidence that the same equivalence argument satisfies the MDR.
Legacy equivalence strategies should therefore be reassessed against the MDR criteria rather than simply migrated into a new CER format.
Priority Actions
If your clinical evaluation currently relies on equivalence:
Map the role equivalence plays in the CER
Determine whether equivalent-device data is supplementary evidence or whether the clinical argument materially depends on it.
Identify every presumed equivalent device
Establish who manufactures it and what access you actually have to the technical, biological and clinical information needed for the comparison.
Re-perform the equivalence assessment against Annex XIV and MDCG 2020-5
Address the technical, biological and clinical characteristics individually and identify differences explicitly.
Check for equivalence drift
Confirm that the information used for both the device under evaluation and the comparator remains current, including changes in design, materials, intended purpose, clinical use and regulatory status.
Assess the consequences before removing an equivalence claim
Determine which clinical data would cease to be directly applicable to your device and whether the remaining evidence is sufficient.
For Class III and implantable devices, distinguish the general equivalence assessment from the Article 61(4)–(5) clinical-investigation exemption
If the strategy relies on another manufacturer's device, confirm whether the specific legal conditions can actually be met.
If equivalence cannot be sustained, revisit the clinical evidence strategy early
The appropriate response may be greater reliance on direct device data, targeted PMCF, other evidence-generation activities or a clinical investigation depending on the device and the identified evidence gap.
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SciMed Perspective
"Do we have an equivalent device?" is not the most important question to be asking ourselves. The important distinction is "What evidential work is the equivalence claim doing, and would the clinical evaluation still stand if that claim failed?" as that changes the way an equivalence review should be approached.
For a CER in which equivalent-device literature provides useful supporting context, failure to demonstrate equivalence may be manageable. For a CER whose conclusions depend heavily on treating a competitor's clinical data as evidence for the manufacturer's own device, the same finding can expose a fundamental gap in the clinical evidence strategy.
This is why equivalence is best assessed early, before the CER is substantially written or an MDR submission is approaching. The earlier the true evidential position is understood, the greater the range of proportionate options available.
How SciMed Can Help
SciMed supports manufacturers with Clinical Evaluation Plans, State-of-the-Art reviews, Clinical Evaluation Reports and lifecycle Clinical Evaluation activities under the EU MDR.
Where equivalence is involved, this can include reviewing existing equivalence claims against MDR Annex XIV and MDCG guidance, determining how much of the clinical evidence base depends on the claim, identifying gaps in the underlying comparator data and developing an appropriate clinical evidence strategy where equivalence cannot be sustained.
For established and legacy devices, that work can also be considered alongside the wider evidence-sufficiency questions addressed by MDCG 2020-6 and the manufacturer's PMS and PMCF evidence.
Primary Sources & Related Guidance
Primary Source
MDCG 2020-5, Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies, Medical Device Coordination Group, April 2020.
Legal Basis
Regulation (EU) 2017/745, Article 61 and Annex XIV Part A.
Related Guidance
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, December 2023.
MEDDEV 2.7/1 Rev.4, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies.
Need support with an equivalence or wider Clinical Evaluation issue?
Continue the Clinical Evaluation Source Series
This article is part of SciMed's Clinical Evaluation source series, covering the principal legal and guidance documents that shape clinical evaluation under the EU MDR.
Related articles:
MDR Annex XIV: What It Requires for Clinical Evaluation and PMCF
MEDDEV 2.7/1 Rev.4 Under EU MDR: What Still Matters and What Has Changed
MDCG 2020-6: Clinical Evidence for Legacy Devices and the WET Route
