---
title: "When can clinical equivalence be used under the EU MDR?"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/equivalence"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/equivalence"
author: "Sorena AI"
description: "EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence."
published_at: "2026-05-09"
updated_at: "2026-05-26"
keywords:
  - "EU MDR clinical equivalence"
  - "medical device equivalence"
  - "MDR clinical evaluation"
  - "MDR PMCF"
  - "Annex XIV"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "Clinical equivalence"
  - "Clinical evaluation"
---
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---

# When can clinical equivalence be used under the EU MDR?

EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence.

*FAQ* *EU 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.

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

Clinical equivalence 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.

## 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. This is not a shortcut around clinical evaluation: the clinical evaluation still has to be planned, continuously conducted, documented, and supported by 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.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - 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](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - 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.

## Class III and implantable-device limits

For implantable devices and class III devices, MDR equivalence is more constrained. MDCG 2020-5 explains that clinical investigations are generally expected unless the device is a modification of a device already marketed by the same manufacturer and equivalence is demonstrated under the MDR.

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 on another manufacturer's device, because the access route and limits differ.
- For devices other than implantable and class III devices, still document sufficient access to the data used for the equivalence claim.

Sources for this answer:

- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - 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.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 61 and Annex XIV provide the MDR basis for clinical evaluation, equivalence, and access to data relating to devices claimed as equivalent.

## How equivalence connects to PMCF

Equivalence evidence should remain connected to the clinical evaluation and PMCF plan. 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. PMCF 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 PMCF plan.
- Keep PMCF 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, PMCF design, or clinical-investigation design when equivalence cannot be demonstrated.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex XIV Part B establishes PMCF as a continuous process that updates clinical evaluation and requires a documented PMCF plan and PMCF evaluation report.
- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - MDCG 2020-5 distinguishes demonstrated equivalence from broader similar-device data that may inform risk management, state of the art, PMCF design, and clinical-investigation design.

## 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.

The strongest evidence package is 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, PMCF plan, PMCF evaluation reports, favourable and unfavourable clinical data considered, and any risk-management or corrective-action updates.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - 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.
- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - MDCG 2020-5 provides an equivalence-table structure for documenting technical, biological, and clinical comparisons and scientific justifications.

## Primary sources

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for Article 61, Annex XIV clinical evaluation, equivalence characteristics, access to equivalent-device data, PMCF, and technical-documentation evidence.
  - Quote: "Considerations of equivalence shall be based on proper scientific justification."
- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - MDCG guidance for manufacturers and notified bodies on demonstrating clinical equivalence, including comparison criteria, access to data, class III and implantable-device constraints, and equivalence-table evidence.
  - Quote: "A guide for manufacturers and notified bodies"

## Topic Guides

- [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain.
- [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records.
- [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact.
- [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): source-linked EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch.
- [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step.
- [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change.
- [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence.
- [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact.
- [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support.
- [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A source-linked EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff.
- [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): source-linked EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review.
- [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls.
- [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): source-linked EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs.
- [EU MDR deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Grounded EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews.
- [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact.
- [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance.
- [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition.
- [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): source-linked EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records.
- [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence.
- [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): source-linked EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence.
- [EU MDR PMS and Vigilance Guide](/artifacts/eu/medical-device-regulation/pms-and-vigilance.md): EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records.
- [EU MDR PMS and vigilance records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): source-linked EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling.
- [EU MDR PMS Plan Template for Medical Devices](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A source-linked EU MDR post-market surveillance plan template covering device scope, PMS data sources, PMCF linkage, vigilance, trend reporting, PMSR or PSUR outputs, roles, cadence, and evidence records.
- [EU MDR QMS and technical file evidence map](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): Map EU MDR Article 10 QMS duties to Annex II and Annex III technical documentation, PMS, vigilance, UDI records, and notified-body review evidence.
- [EU MDR QMS requirements under Article 10](/artifacts/eu/medical-device-regulation/qms.md): EU MDR QMS guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records.
- [EU MDR qualification and borderline products](/artifacts/eu/medical-device-regulation/qualification-and-borderline-products.md): EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment.
- [EU MDR qualification workflow](/artifacts/eu/medical-device-regulation/qualification-workflow.md): A concrete EU MDR workflow for deciding whether a product is a medical device, accessory, Annex XVI product, IVD interface, medicinal-product interface, or non-MDR product before classification and conformity assessment.
- [EU MDR requirements checklist](/artifacts/eu/medical-device-regulation/requirements.md): Concrete EU MDR requirements for medical-device scope, classification, GSPR, conformity assessment, technical documentation, QMS, clinical evidence, UDI, EUDAMED, PMS, vigilance, and economic-operator records.
- [EU MDR Rule 11 software classification](/artifacts/eu/medical-device-regulation/rule-11-software.md): Classify MDR medical device software under Rule 11 using intended purpose, diagnosis or therapy decision impact, physiological monitoring, conformity route, clinical evidence, and software-change records.
- [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md): FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts.
- [EU MDR Transition Timelines: practical guide](/artifacts/eu/medical-device-regulation/transition-timelines.md): EU Medical Device Regulation guide to Transition Timelines with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps.
- [EU MDR UDI and EUDAMED registration guide](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance.
- [EU MDR vigilance reporting workflow](/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow.md): Concrete EU MDR vigilance workflow for incident intake, serious incident assessment, FSCA and FSN handling, trend reporting, EUDAMED caveats, CAPA, PMS, clinical evaluation updates, and records.
- [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md): EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence.
- [MDR vs AI Act for medical-device software](/artifacts/eu/medical-device-regulation/mdr-vs-ai-act.md): Compare MDR software qualification, classification, clinical evidence, QMS, PMS, UDI, EUDAMED, and notified-body evidence boundaries against cautiously scoped AI Act overlap.
- [MDR vs GPSR: medical-device boundary checks](/artifacts/eu/medical-device-regulation/mdr-vs-gpsr.md): Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products.
- [MDR vs IVDR: medical devices and IVDs compared](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance.
- [MDR vs Product Liability Directive evidence comparison](/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive.md): Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome.
- [What should an EU MDR PMCF plan and report cover? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/pmcf.md): Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover.
- [What should manufacturers do when an EU MDR classification changes? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/class-changes.md): Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence.
- [When do software or products make medical purpose claims under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md): EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep.
- [When is a PSUR required under the EU MDR and what should it contain? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/psur.md): EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain.
- [When is an accessory regulated under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/accessories.md): EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep.
- [When is software regulated as SaMD under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/software-and-samd.md): Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED.
- [Which devices need an SSCP under the EU MDR and what should it include? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/sscp.md): EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary.
- [Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/eudamed-modules.md): EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records.

*Recommended next step*

*Placement: after evidence section*

## 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.

- [Open Research Copilot](/solutions/research-copilot.md): Answer MDR clinical evaluation and equivalence questions with cited outputs.
- [Talk through implementation](/contact.md): Review your MDR evidence model, clinical evaluation file, and PMCF plan.


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