Equivalence (EU MDR) is the regulated demonstration that a medical device is sufficiently similar to an already-marketed device that clinical data from that device can support its clinical evaluation. Under Annex XIV Part A of Regulation (EU) 2017/745, the two devices must match across technical, biological, and clinical characteristics with no clinically significant difference in safety or performance.
What is Equivalence (EU MDR)?
Equivalence is a route within clinical evaluation, not a standalone regulatory approval. It sits inside the clinical evaluation process described in Article 61 and Annex XIV Part A of the EU Medical Device Regulation (MDR), Regulation (EU) 2017/745. When a manufacturer cannot or does not want to generate all clinical evidence from its own investigations, it may reference an equivalent device and rely on that device’s clinical data to help show conformity with the General Safety and Performance Requirements.
The core idea is narrow. The device under evaluation and the equivalent device must be close enough that any differences carry no clinically significant effect on safety or clinical performance. MDCG 2020-5, the guidance from the Medical Device Coordination Group, sets out how notified bodies expect that comparison to be built and documented.
Why Equivalence (EU MDR) matters in medical device development
Equivalence (EU MDR) can decide whether a program needs a full pre-market clinical investigation or can lean on existing data. That difference affects budget, timeline, and risk. A defensible equivalence claim can remove months of study work. A weak one collapses under notified body review and forces a late pivot to new clinical data.
The stakes rise with device class. For implantable and Class III devices, Article 61(4) to (6) sharply limits when equivalence can substitute for a clinical investigation. Get the claim wrong, and the technical documentation fails assessment, delaying CE marking. Get it right, and the same clinical evidence supports both the initial submission and the ongoing clinical evaluation report.
How Equivalence (EU MDR) works
Annex XIV Part A requires the manufacturer to compare the two devices across three characteristics, all of which must hold:
- Technical: similar design, conditions of use, specifications, properties, principles of operation, and critical performance requirements.
- Biological: the same materials or substances in contact with the same tissues or body fluids, with similar contact duration and release characteristics, including degradation products and leachables.
- Clinical: the same clinical condition or purpose, the same site in the body, a similar patient population, and comparable performance for the intended use.
Each difference between the devices has to be identified and backed by a scientific justification showing it does not change safety or clinical performance. MDCG 2020-5 provides an equivalence table template in its Annex I for exactly this. One point that trips teams up: under the MDR, the biological “same materials” test is strict, and the softer “similar materials” allowance from the older MEDDEV 2.7/1 Rev. 4 no longer applies.
Access to data is the other gate. For implantable and Class III devices claiming equivalence to another manufacturer’s device, Article 61(5) requires a contract giving full, ongoing access to that device’s technical documentation. In practice, few competitors agree, which is why cross-manufacturer equivalence for high-risk devices is rare. MDCG 2023-7 sets out the specific cases where implantable and Class III devices may still avoid a clinical investigation.
Common challenges and best practices
The frequent failure is treating equivalence as a paperwork exercise. A claim that lists similarities but glosses over differences will not survive assessment. Document every difference and justify it against clinical significance, with reference to the equivalent device’s data.
Confirm the data-access question early. If the equivalent device belongs to a competitor and yours is Class III or implantable, the Article 61(5) contract requirement often makes the route impractical, so test feasibility before building a strategy around it. Remember, too, that MDD-certified devices generally cannot anchor an equivalence claim for implantable and Class III devices, where the equivalent device usually needs certification under the MDR.
Treat the claim as living. If the equivalent device is modified or its data changes, revisit the justification. Strong teams keep the equivalence assessment inside the clinical evaluation report and update it as the state of the art moves, rather than freezing it at certification.
How SJML helps with Equivalence (EU MDR)
SJML supports equivalence work as part of its clinical evaluation and regulatory services. The QARA teams build clinical evaluation plans and reports (CEP and CER), run structured literature reviews, and assemble the technical, biological, and clinical comparison that an equivalence claim depends on. They align the justification with Annex XIV Part A and MDCG 2020-5 expectations, flag data-access and device-class constraints early, and fold the assessment into a maintained clinical evaluation file so it stays defensible through notified body review and post-market updates.
Frequently asked questions
Equivalence under EU MDR requires matching across technical, biological, and clinical characteristics, defined in Annex XIV Part A. Technical covers design and operating conditions, biological covers materials in tissue contact, and clinical covers the condition, body site, and patient population. All three must hold, and any difference must be scientifically justified as having no clinically significant effect on safety or performance.
Sometimes, but it is limited. For implantable and Class III devices, Article 61(5) requires a formal contract giving full, ongoing access to the competitor’s technical documentation, which few manufacturers grant. For lower-risk devices, a contract is not mandatory, though you still need sufficient access to the equivalent device’s data to justify the claim to your notified body.
MDCG 2020-5 is guidance, not binding law, but notified bodies apply it closely, so treating it as optional is risky. It interprets the Annex XIV Part A requirements, clarifies where the MDR is stricter than the older MEDDEV 2.7/1 Rev. 4, and provides an equivalence table template. A claim that ignores its structure is likely to draw questions during conformity assessment.
No. Even when equivalence supports the initial clinical evaluation, post-market clinical follow-up under Annex XIV Part B remains a continuing duty. An appropriate PMCF plan is generally expected, especially for implantable and Class III devices relying on equivalence, so field data keeps feeding the clinical evaluation report over the device’s life.
Related terms
- Clinical Evaluation Report (CER)
- Clinical Evaluation Plan (CEP)
- General Safety and Performance Requirements (GSPR)
- Post-Market Clinical Follow-up (PMCF)
- Notified Body
