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FAQEU MDR

EU MDR FAQ Clinical Equivalence

Clinical equivalence under the EU Medical Device Regulation is a way to use clinical data from another device only when equivalence is demonstrated and justified in the clinical evaluation.

This FAQ helps check the MDR characteristics, data-access requirement, high-risk-device limits, PMCF link, and evidence record before relying on equivalent-device data.

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Author
Sorena AI
Published
May 9, 2026
Updated
Jul 24, 2026
Questions
4

Structured answer sets in this page tree.

Primary sources
2

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 24, 2026
Overview

under the EU MDR can be used only when the manufacturer demonstrates that the compared device is technically, biologically, and clinically equivalent, that any differences do not create a clinically significant difference in safety or clinical performance, and that the manufacturer has sufficient access to the data needed to justify the claim.

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4 of 4 questions
Question 1

When clinical equivalence can support an MDR clinical evaluation

The MDR allows a clinical evaluation to rely on clinical data for another device only where equivalence to the device under evaluation can be demonstrated. The manufacturer must still plan, continuously conduct, and document the clinical evaluation in a clinical evaluation report.

The equivalence argument has to cover technical, biological, and clinical characteristics. The comparison should identify differences, explain why they are not clinically significant for safety or clinical performance, and point to the underlying data rather than relying on a shared product category or broad similarity claim.

  • Technical: compare design, conditions of use, specifications and properties, deployment methods, principles of operation, critical performance requirements, and software algorithms where relevant.
  • Biological: compare the same materials or substances in contact with the same tissues or body fluids, including kind and duration of contact and release characteristics such as degradation products and leachables.
  • Clinical: compare the same clinical condition or purpose, site in the body, similar population, same kind of user, and relevant critical performance for the expected clinical effect.
  • Access: retain evidence that the manufacturer has sufficient access to the equivalent-device data needed to justify the equivalence claim.

When can be used under the EU Medical Device Regulation?

can be used when the manufacturer demonstrates equivalence across the MDR technical, biological, and clinical characteristics, gives a proper scientific justification that differences are not clinically significant for safety or clinical performance, and has sufficient access to the equivalent-device data needed to justify the claim. If those conditions are not met, the manufacturer should not use equivalence as clinical evidence for conformity assessment.

Does equivalence replace the MDR clinical evaluation or ?

No. Equivalence may allow clinical data from another device to enter the clinical evaluation, but the manufacturer must still conduct and document the clinical evaluation. The manufacturer must address in the post-market surveillance plan or justify why PMCF is not applicable; where PMCF is performed, it is a continuous process that updates the clinical evaluation.

Citations
Regulation (EU) 2017/745 on medical devices

Annex XIV supports the three equivalence characteristics, scientific-justification requirement, data-access requirement, clinical evaluation report, PMCF, and technical-documentation evidence.

MDCG 2020-5 - Clinical Evaluation - Equivalence

MDCG 2020-5 explains how manufacturers and notified bodies should demonstrate equivalence under the MDR, including comparison tables, data access, class III and implantable-device limits, and use of similar-device data.

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Review your MDR equivalence evidence

Use the clinical-equivalence record to test whether the MDR comparison, data access, clinical evaluation, and PMCF evidence are strong enough before relying on another device's clinical data.

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Question 2

Class III and implantable-device limits

For implantable devices and class III devices, clinical investigations are generally required. The same-manufacturer modification route in Article 61(4) applies only when the manufacturer demonstrates equivalence to its already marketed device, the notified body endorses that demonstration, the marketed device's clinical evaluation is sufficient for the modified device, and the notified body confirms that the plan is appropriate and includes post-market studies.

Where a manufacturer of an implantable or class III device claims equivalence to a device from another manufacturer, MDCG 2020-5 identifies the MDR contract requirement: the manufacturer needs full access to the technical documentation on an ongoing basis. The guidance also notes that this means relying on a device certified only under the old directives will not be possible for that route.

  • Do not use a competitor equivalence claim for a class III or implantable device unless the access-to-technical-documentation requirement is actually met.
  • For high-risk devices, check whether the claim is based on a same-manufacturer modification or another manufacturer's device, because the access conditions differ and both routes retain the other Article 61(4) safeguards.
  • For devices other than implantable and class III devices, still document sufficient access to the data used for the equivalence claim.
Citations
MDCG 2020-5 - Clinical Evaluation - Equivalence

The guidance gives the class III and implantable-device limits for equivalence, including same-manufacturer modification and full ongoing technical-documentation access for another manufacturer's device.

Question 3

How equivalence connects to PMCF

Equivalence evidence should remain connected to the clinical evaluation and the plan or justification why PMCF is not applicable. MDR Annex XIV treats PMCF as the continuous process that updates the clinical evaluation, confirms safety and performance over the device lifetime, checks the benefit-risk ratio, and detects emerging risks on factual evidence.

Equivalent or similar devices may also matter after market entry, but not as a substitute for data on the device under evaluation. should identify which equivalent or similar-device data will be monitored, why it is relevant, and how new findings will update the clinical evaluation, risk management, or corrective actions.

  • Link the equivalence table to the clinical evaluation report and the plan or justification why PMCF is not applicable.
  • Keep objectives specific to the device's intended purpose, clinical claims, known risks, and evidence gaps.
  • Use similar-device data for state of the art, risk signals, outcome parameters, design, or clinical-investigation design when equivalence cannot be demonstrated.
Citations
Question 4

Evidence to retain

Retain a reviewer-ready record showing which device was assessed, which presumed equivalent device was used, what data were available, and why the manufacturer concluded that the MDR equivalence criteria were met. The record should sit with the clinical evaluation report and technical documentation, not in an informal rationale detached from the conformity-assessment file.

Use a structured equivalence table with device-by-device comparisons, data references, identified differences, scientific justifications, and conclusions on whether any difference is clinically significant.

  • Device identity, intended purpose, clinical condition, target population, user type, site in the body, and relevant critical performance claims.
  • Technical comparison for design, conditions of use, specifications, software algorithms, deployment methods, principles of operation, and critical performance requirements.
  • Biological comparison for materials or substances, body contact, contact duration, release characteristics, degradation products, and leachables.
  • Evidence of access to equivalent-device data, including technical documentation access where the MDR route requires it.
  • Clinical evaluation report, plan and PMCF evaluation reports or justification why PMCF is not applicable, favourable and unfavourable clinical data considered, and any risk-management or corrective-action updates.
Citations
Regulation (EU) 2017/745 on medical devices

The MDR requires the clinical evaluation results, clinical evidence, favourable and unfavourable data, PMCF outputs, and supporting documentation to be documented in the clinical evaluation report and technical documentation.

Primary sources

References and citations

MDCG 2020-5 - Clinical Evaluation - Equivalence
health.ec.europa.eu
Referenced sections
  • MDCG 2020-5 provides an equivalence-table structure for documenting technical, biological, and clinical comparisons and scientific justifications.
"The documentation of the demonstration of equivalence shall be included"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • The MDR requires the clinical evaluation results, clinical evidence, favourable and unfavourable data, PMCF outputs, and supporting documentation to be documented in the clinical evaluation report and technical documentation.
"Both favourable and unfavourable data considered in the clinical evaluation"
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