Your device is very close to one already on the market. Same intended purpose, similar design, perhaps even the same contract manufacturer. Under the old Directives, that might have been enough to base most of your clinical evaluation on the other device’s published data. Under the MDR, the notified body’s clinical reviewer will ask a much harder set of questions.
Demonstrating equivalence under MDR (Regulation (EU) 2017/745) means proving technical, biological and clinical equivalence, showing you have sufficient access to the other device’s data, and, for class III and implantable devices, meeting the extra conditions in Article 61(4)–(6). This guide walks through Annex XIV Part A section 3, MDCG 2020-5 and MDCG 2023-7 so you can decide early whether equivalence is a viable route.
Where equivalence fits in the MDR clinical evaluation
Equivalence is not a separate approval route. It is one way of obtaining clinical data. Article 2(48) MDR includes, within clinical data, studies in the scientific literature on a device whose equivalence to the device in question can be demonstrated, and peer-reviewed clinical experience with such a device. Article 61(3)(a) requires that, where the manufacturer relies on literature about another device, equivalence is demonstrated in accordance with Annex XIV Part A section 3 and the data adequately demonstrate compliance with the relevant general safety and performance requirements.
The equivalence analysis sits inside the clinical evaluation report. For the overall plan, literature search and benefit-risk analysis, see our guide on how to write a clinical evaluation report under EU MDR.
The three equivalence criteria under MDR: Annex XIV Part A section 3
Technical characteristics. The device is of similar design; is used under similar conditions of use; has similar specifications and properties, including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; and has similar principles of operation and critical performance requirements.
Biological characteristics. The device uses the same materials or substances in contact with the same human tissues or body fluids, for a similar kind and duration of contact, and with similar release characteristics of substances, including degradation products and leachables.
Clinical characteristics. The device is 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 age, anatomy and physiology; has the same kind of user; and has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
Section 3 then requires the characteristics to be similar to the extent that there would be no clinically significant difference in safety and clinical performance, and requires equivalence to be based on proper scientific justification. The manufacturer must also clearly demonstrate sufficient levels of access to the data on the device claimed to be equivalent.
Note the words “same” and “similar”. MDCG 2020-5 flags that items such as materials in contact, the site in the body and the kind of user must be the same, not merely similar.
What MDCG 2020-5 changed compared with MEDDEV 2.7/1 rev 4
MDCG 2020-5, “Clinical evaluation – Equivalence” (April 2020), states that some requirements of MEDDEV 2.7/1 rev 4 are not fully aligned with the MDR and that the MDR takes precedence. The practical differences it highlights:
- Materials (section 3.2(a)). MEDDEV-era exceptions, for example for materials contacting only intact skin or minor components, are not acceptable under the MDR.
- Software (section 3.1(b)). Similar software algorithms are now explicitly required. The focus is the functional principle, clinical performance and intended purpose; the code itself need not be shown equivalent if developed under recognised standards such as IEC 62304.
- Kind of user (section 3.3(a)). The MDR adds “same kind of user”, so a professional-use device and a lay-use device are not equivalent on this point.
- Final device, not raw material. Biological equivalence considers the finished device, because processing, sterilisation and residues can change leachables; ISO 10993-1 and ISO 10993-18 are named as useful tools.
- Drug-device combinations. Equivalence cannot be claimed between a device with a medicinal substance and one without.
Building the equivalence table
MDCG 2020-5 Annex I provides an example comparison table. It is not exhaustive, and it expects:
- a separate table for each presumed equivalent device, placed in the clinical evaluation report;
- a focus on differences rather than similarities, with each difference either scientifically justified as having no clinically significant effect or its impact described;
- consideration of the cumulative effect of several small differences;
- data tied to a defined version of the equivalent device, since generations can differ significantly.
Section 4(b) allows more than one equivalent device, but each must be equivalent in all characteristics. You cannot combine the materials of one device with the clinical data of another.
Sufficient levels of access to the equivalent device’s data
Without sufficient access, MDCG 2020-5 section 4(c) says equivalence cannot be claimed. MDCG 2023-7 (December 2023), written for implantable and class III devices, explains that this is access to the data needed to establish the technical, biological and clinical characteristics, not necessarily the complete technical documentation. The CER must explain why access is sufficient, and the notified body must accept that reasoning.
MDCG 2023-7 Table 2 gives illustrative levels: full access through a contract, a modification of your own device or acquired design rights; high access where a common subcontractor supplies the same design and you see its specifications; medium access through comparative testing of samples plus public information such as the IFU or summary of safety and clinical performance (SSCP); and low access where specifications come from public information only. Lower levels need mitigation, such as clinical data on your own device, critical appraisal of literature for bias, and post-market clinical follow-up (PMCF). A higher level of access does not automatically make the equivalence demonstration stronger.
Class III and implantable devices: Article 61(4), (5) and (6)
Article 61(4) requires clinical investigations for implantable and class III devices unless specific exemptions apply. MDCG 2023-7 describes them as independent cases:
- Modification of your own marketed device (Article 61(4)). Equivalence must be demonstrated under Annex XIV section 3 and endorsed by the notified body, the clinical evaluation of the marketed device must suffice to show conformity of the modified device, and the notified body checks that the PMCF plan includes post-market studies.
- Another manufacturer’s device (Article 61(5)). The same conditions, plus a contract that explicitly allows full access to the technical documentation on an ongoing basis, and an original clinical evaluation performed in compliance with the MDR, with clear evidence of both provided to the notified body. MDCG 2020-5 section 4(d) reads this as implying the equivalent device is certified under the MDR, so equivalence to a Directive-certified device is not possible on this route.
- Legacy devices and listed device types (Article 61(6)). Devices lawfully placed on the market under Directive 90/385/EEC or 93/42/EEC, and sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors, where the clinical evaluation is based on sufficient clinical data and complies with any relevant common specification. MDCG 2023-7 confirms these cases do not need the Article 61(5) contract.
For devices that are neither class III nor implantable, MDCG 2020-5 section 4(e) allows equivalence to devices certified under the Directives or the MDR, and no contract is required, although sufficient access must still be shown. Confirm the classification first, because it decides which rules apply.
Similar devices are not equivalent devices
MDCG 2020-5 section 5 distinguishes “similar devices” in the same generic device group. Their data cannot establish equivalence, but they can inform the state of the art, risk management, acceptable adverse event rates and PMCF design. MDCG 2020-6 ranks equivalence data fifth in its hierarchy of clinical evidence and expects reliance on equivalence to be linked to PMCF or proactive post-market surveillance; see our article on the PMCF plan and evaluation report.
Where this goes wrong
- Mixing devices. Using one device for technical equivalence and another for clinical data. Each equivalent device must meet all three criteria.
- Tables that list similarities. Reviewers want every difference identified and justified, including the cumulative effect.
- Raw-material biological comparisons. Same polymer grade is not enough if processing, sterilisation or additives differ.
- No access argument. Relying on a competitor’s IFU and publications without explaining, per MDCG 2023-7, why that access is sufficient.
- Ignoring the kind of user. A home-use version of a hospital device fails the “same kind of user” criterion.
- Class III claims to Directive-certified comparators. Under MDCG 2020-5, the Article 61(5) route needs an MDR-certified equivalent device and a contract.
- Equivalence without PMCF. Treating equivalence as the end of the evidence story rather than a starting point to confirm post-market.
Frequently asked questions
Can I claim equivalence to a competitor’s device under EU MDR?
Yes, but you must show technical, biological and clinical equivalence under Annex XIV Part A section 3 and sufficient access to the data. For class III and implantable devices, Article 61(5) also requires a contract giving full, ongoing access to the technical documentation, and MDCG 2020-5 reads this route as requiring an MDR-certified equivalent device.
Can I use more than one equivalent device?
Yes. MDCG 2020-5 section 4(b) allows more than one equivalent device, but each one must be equivalent to your device in all technical, biological and clinical characteristics, with its own comparison table. You cannot assemble equivalence by taking technical characteristics from one device and clinical characteristics from another.
Is the same material from the same supplier enough for biological equivalence?
Not on its own. Annex XIV requires the same materials in contact with the same tissues, a similar kind and duration of contact, and similar release of substances, including degradation products and leachables. MDCG 2020-5 asks for the finished device to be considered, because processing, sterilisation and residues can change what is released.
What does “sufficient levels of access” mean?
It means access to the data needed to justify technical, biological and clinical equivalence. MDCG 2023-7 says this does not always mean the full technical documentation, gives illustrative access levels from a full contract down to public information only, and expects the CER to explain why access is sufficient and how any limitations are mitigated.
Does equivalence remove the need for PMCF?
No. Article 61(11) requires the clinical evaluation to be updated with PMCF data throughout the life cycle. For the Article 61(4) route, the notified body checks that the PMCF plan includes post-market studies, and MDCG 2020-6 expects reliance on equivalence to be linked to PMCF or proactive post-market surveillance.
Medfins has supported 175+ regulatory projects covering 250+ products for 100+ clients, including equivalence assessments and clinical evaluation reports prepared for notified body review. If you want an early view of whether an equivalence route will hold for your device, see our CE marking under EU MDR service or contact our team.
