---
title: MDCG Guidance on Clinical Evaluation: What Startups Need to Know
description: MDCG has published key clinical evaluation guidance documents that clarify MDR Article 61. Here are the main MDCG documents for startups and how to apply them.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: MDCG guidance clinical evaluation
canonical_url: https://zechmeister-solutions.com/en/blog/mdcg-guidance-clinical-evaluation
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# MDCG Guidance on Clinical Evaluation: What Startups Need to Know

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **The Medical Device Coordination Group (MDCG) has published two clinical evaluation guidance documents that every startup working on an MDR clinical evaluation has to know: MDCG 2020-5 on equivalence (April 2020) and MDCG 2023-7 on clinical investigation exemptions and "sufficient levels of access" to data (December 2023). They do not replace MDR Article 61 or Annex XIV. They interpret them. Under MDR they take precedence over the legacy MEDDEV 2.7/1 Rev 4 wherever the two diverge, and notified bodies apply them directly when reviewing a clinical evaluation report.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- The MDCG is the expert group established under MDR Article 103 that issues non-binding but authoritative guidance on how the Regulation is applied in practice.
- Two MDCG documents are central to clinical evaluation: MDCG 2020-5 (equivalence, April 2020) and MDCG 2023-7 (clinical investigation exemptions for implantable and Class III devices, December 2023).
- MDCG 2020-5 is the MDR-era successor to the equivalence sections of MEDDEV 2.7/1 Rev 4. It raises the bar on technical, biological, and clinical equivalence and is stricter than its predecessor.
- MDCG 2023-7 clarifies Article 61(4)-(6), the narrow conditions under which pre-market clinical investigations for implantable and Class III devices may be avoided, and defines what "sufficient levels of access" to clinical data means in practice.
- MDCG guidance is not law. MDR Article 61 and Annex XIV Part A are the legal text. But notified bodies apply the MDCG interpretation consistently, which means in practice the guidance sets the bar.
- A clinical evaluation report that cites only MEDDEV 2.7/1 Rev 4 and ignores MDCG 2020-5 and MDCG 2023-7 will generate findings at review. Citing the MDR text together with the applicable MDCG documents is normal 2026 practice.

---

## What the MDCG is and why its guidance matters

The Medical Device Coordination Group is the expert body established under MDR Article 103. It is composed of member state representatives and chaired by the European Commission. Its mandate is to advise and assist the Commission and the member states in the consistent application of the MDR and IVDR, and one of its main outputs is guidance documents on specific regulatory questions.

MDCG guidance is not legally binding. The binding text is the Regulation itself. Regulation (EU) 2017/745, with its articles and annexes, amended by Regulation (EU) 2023/607 on the transitional provisions. Guidance documents do not create new obligations. What they do is tell manufacturers and notified bodies how the Commission and the member states expect the existing obligations to be interpreted. In practice, notified bodies apply that interpretation consistently. That is why "non-binding" guidance drives real-world review outcomes, and why ignoring it is not a safe strategy.

For clinical evaluation specifically, two MDCG documents carry most of the weight in 2026: MDCG 2020-5 on equivalence, and MDCG 2023-7 on clinical investigation exemptions. There are others that touch clinical evaluation at the edges. Guidance on software, on classification, on PMS, on vigilance. But these two are the core clinical evaluation references.

## MDCG 2020-5. Equivalence, the key points

MDCG 2020-5, full title "Clinical Evaluation. Equivalence: A guide for manufacturers and notified bodies", was published in April 2020. It is the MDR-era authority on how equivalence claims are assessed, and it is the document that explicitly updates the equivalence approach that MEDDEV 2.7/1 Rev 4 (June 2016) codified under the former Directives.

The main points a startup working on an equivalence-based clinical evaluation has to internalise:

**Three characteristics, all required.** MDR Annex XIV Part A Section 3 requires equivalence to be demonstrated on three characteristics. Technical, biological, and clinical. And MDCG 2020-5 walks through each one. Technical equivalence covers device design, specifications, physical properties, principles of operation, critical performance requirements, software algorithms where relevant, and conditions of use. Biological equivalence covers the materials or substances in contact with the same human tissues or body fluids, for similar duration and frequency. Clinical equivalence covers the same clinical condition, same intended purpose, same site in the body, similar population, similar performance. All three must be met.

**No clinically significant difference in safety and clinical performance.** The three characteristics must be met to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. This is a higher bar than the MEDDEV 2.7/1 Rev 4 language suggested under the Directives. Small technical differences that would have been tolerated as "similar enough" in the MDD era are now routinely challenged.

**Equivalence must be justified with evidence, not asserted.** MDCG 2020-5 is explicit that manufacturers must provide a substantiated scientific justification for each of the three characteristics, based on evidence from the technical file of both devices. A paragraph of narrative without supporting data is not a justification.

**Notified body scrutiny is higher under MDR.** The guidance tells notified bodies what to look for, and the bar is higher than under the Directives. A CER whose equivalence claim was previously accepted under MDD review is not guaranteed to pass under MDR review. The guidance explicitly anticipates this and signals that legacy equivalence arguments need to be re-assessed.

**Data from similar (non-equivalent) devices.** MDCG 2020-5 also addresses the use of data from devices that are similar but not equivalent under the MDR definition. Such data cannot carry an equivalence claim, but it can contribute to the broader body of clinical evidence as supporting context, provided its role is honestly labelled.

## MDCG 2023-7. Clinical investigation exemptions, the key points

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", was published in December 2023. It addresses the narrow set of conditions under which implantable and Class III devices may be exempted from the general requirement to perform pre-market clinical investigations.

The key points:

**The default is clinical investigation.** Article 61(4) establishes that for implantable and Class III devices, clinical investigations shall be performed. Exemptions are the exception, not the rule. MDCG 2023-7 repeatedly reinforces this and warns against treating the exemptions as a planning default.

**Four exemption cases.** The guidance clarifies the cases in which an exemption is legally available: modifications of a device already marketed by the same manufacturer and demonstrated equivalent; equivalence to a device marketed by another manufacturer, subject to strict conditions; devices lawfully placed on the market under the former Directives with sufficient clinical data and compliance with any applicable product-specific common specifications; and certain well-established technologies listed in Article 61(6)(b) such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, again subject to common specifications where available.

**"Sufficient levels of access" is the test that blocks most equivalence-based exemptions.** For equivalence to a device from another manufacturer, Article 61(5) requires sufficient levels of access to the clinical data and technical documentation of the equivalent device on an ongoing basis. MDCG 2023-7 clarifies that this means a contract between the two manufacturers granting continuous access, not a one-off data purchase, not a single-point comparison, not information inferred from public sources. The contract must give the manufacturer access sufficient to support both the initial conformity assessment and the ongoing clinical evaluation lifecycle, including PMCF updates.

**No contract, no equivalence-based exemption.** For most startups claiming equivalence to a competitor device, the sufficient-levels-of-access test is where the plan breaks. Competitors rarely sign contracts granting ongoing access to their clinical and technical documentation. MDCG 2023-7 is not hostile to equivalence. It is honest about the conditions.

**The guidance interacts with MDCG 2020-5.** Where MDCG 2020-5 defines what equivalence is, MDCG 2023-7 defines what access to data is required to use equivalence to avoid a clinical investigation. The two documents must be read together for any implantable or Class III equivalence claim.

## How the MDCG documents differ from MEDDEV 2.7/1 Rev 4

MEDDEV 2.7/1 Rev 4 is legacy guidance written for the former Directives. The MDCG clinical evaluation documents are MDR-era guidance that explicitly updates and, in specific places, replaces parts of the MEDDEV text. The differences that matter in practice:

- **Legal basis.** MEDDEV 2.7/1 Rev 4 cites Directive articles. MDCG 2020-5 and MDCG 2023-7 cite MDR articles. Any CER that cites the Directive articles for current compliance is out of date on its face.
- **Equivalence bar.** MDCG 2020-5 raises the bar on all three equivalence characteristics compared to the MEDDEV 2.7/1 Rev 4 approach and is explicit that this is a change, not a restatement.
- **Clinical investigation default.** MDCG 2023-7 reflects Article 61(4), which establishes clinical investigations as the default for implantable and Class III devices. MEDDEV 2.7/1 Rev 4 predates this default and does not carry it.
- **"Sufficient levels of access".** This concept does not appear in MEDDEV 2.7/1 Rev 4 in the form Article 61(5) uses it. MDCG 2023-7 is the place where the concept is operationalised for practice.
- **Lifecycle emphasis.** The MDCG documents reinforce the MDR lifecycle framing of clinical evaluation, including the PMCF feedback loop under Annex XIV Part B. MEDDEV 2.7/1 Rev 4 has a lighter lifecycle cadence.

The practical hierarchy in 2026: MDR text first, MDCG 2020-5 and MDCG 2023-7 second where they apply, MEDDEV 2.7/1 Rev 4 as a methodological reference for the four-stage process and literature appraisal discipline only.

## How to cite MDCG guidance in your CER

Citation practice in a clinical evaluation report is one of the places where a well-prepared CER and a casually prepared one diverge visibly. The discipline is straightforward.

Cite the MDR as the primary authority. Every clinical evaluation requirement traces to a specific article or annex paragraph. The CER should state the requirement and cite the MDR text, for example: "Clinical evaluation is conducted in accordance with Regulation (EU) 2017/745, Article 61 and Annex XIV Part A."

Cite MDCG 2020-5 for equivalence claims. If the CER uses equivalence as a data source, cite MDCG 2020-5 by full title and date. "MDCG 2020-5, Clinical Evaluation. Equivalence: A guide for manufacturers and notified bodies, April 2020". And walk through the three characteristics explicitly, each with its own evidence.

Cite MDCG 2023-7 for implantable and Class III exemption arguments. If the device is implantable or Class III and the CER argues that pre-market clinical investigation is not required under Article 61(5) or 61(6), cite MDCG 2023-7 by full title and date and show which of the four cases applies, with the evidence for that case. For equivalence-based exemptions, show the contractual access arrangement that satisfies "sufficient levels of access".

Cite MEDDEV 2.7/1 Rev 4 only as a methodological reference, and only with the note that it is legacy guidance that is superseded by the MDR text and MDCG guidance wherever the two diverge. A CER that cites it as primary authority for any current requirement is behind by years.

List every cited guidance document in the references section with full title, document number, and publication date. Notified body reviewers check the list.

## Common misapplications

The same mistakes appear repeatedly in CERs that land on a reviewer's desk.

- **Treating MDCG guidance as optional.** The guidance is not legally binding, but notified bodies apply it. A CER that ignores MDCG 2020-5 on equivalence because "it is only guidance" is a CER that will generate findings.
- **Making an equivalence claim without addressing all three characteristics.** MDCG 2020-5 is explicit that technical, biological, and clinical equivalence must each be demonstrated with evidence. Skipping biological equivalence because "we use similar materials" is not a justification.
- **Assuming MDCG 2023-7 exemptions apply without reading the conditions.** The four cases in Article 61(5)-(6) are narrow. Every case has specific conditions, and MDCG 2023-7 walks through them. Claiming an exemption without matching the conditions is the kind of error that blocks a conformity assessment for months.
- **Claiming sufficient levels of access without a contract.** MDCG 2023-7 is unambiguous. An equivalence-based exemption to clinical investigation for an implantable or Class III device requires ongoing contractual access to the equivalent device's clinical data and technical documentation. Without the contract, the exemption does not hold.
- **Citing MEDDEV 2.7/1 Rev 4 as primary authority.** The MDR and the MDCG documents take precedence. MEDDEV has a legitimate place as a methodological reference for the four-stage clinical evaluation process, not as a substitute for MDCG 2020-5 or the MDR text.
- **Not updating CERs when new MDCG guidance is published.** MDCG 2023-7 is a December 2023 document. CERs drafted before that date and not revisited are already behind. Clinical evaluation is a lifecycle process, and the reference list is part of the lifecycle.

## The Subtract to Ship angle

The Subtract to Ship framework treats MDCG guidance the same way it treats every other regulatory input: use what earns its place by tracing to a specific obligation, and ignore the rest. For clinical evaluation in 2026 this produces a short list. MDR Article 61 and Annex XIV Part A are mandatory. MDCG 2020-5 is mandatory in substance if the CER uses equivalence. MDCG 2023-7 is mandatory in substance if the device is implantable or Class III and the CER argues exemption from pre-market clinical investigation. Everything else. MEDDEV 2.7/1 Rev 4, older guidance, textbook citations. Is methodological scaffolding that supports the mandatory work, not a substitute for it.

The Evidence Pass of the framework applies directly. Before writing an equivalence argument, read MDCG 2020-5 and ask honestly whether the three characteristics can be met with evidence. Before building a clinical evaluation plan around an Article 61 exemption, read MDCG 2023-7 and ask honestly whether the access conditions are satisfied. The guidance is not an obstacle. It is the reality check that prevents a CER from being built on an argument the notified body will reject.

## Reality Check. Where do you stand?

1. Have you read MDCG 2020-5 in full, not summaries, and can you state the three equivalence characteristics and the evidence expected for each?
2. If your CER claims equivalence, does it walk through technical, biological, and clinical characteristics separately with evidence for each, or does it bundle them into a single paragraph?
3. If your device is implantable or Class III and you plan to argue exemption from pre-market clinical investigation, have you read MDCG 2023-7 and identified which of the four cases in Article 61(5)-(6) you are relying on?
4. For an equivalence-based exemption under Article 61(5), do you have an ongoing contractual arrangement with the other manufacturer that satisfies the "sufficient levels of access" test in MDCG 2023-7?
5. Does your CER reference list cite MDR Article 61 and Annex XIV Part A, MDCG 2020-5, and MDCG 2023-7 where they apply, with full document titles and publication dates?
6. Are you still citing MEDDEV 2.7/1 Rev 4 as primary authority for equivalence or clinical investigation requirements, and if so, why?
7. When the next MDCG clinical evaluation guidance is published, do you have a process that will pick it up and update the CER, or will your CER drift out of date the moment the reference list changes?

## Frequently Asked Questions

**Is MDCG guidance legally binding under the MDR?**
No. MDCG guidance documents are non-binding. The legally binding text is Regulation (EU) 2017/745 itself, including its articles and annexes. In practice, however, notified bodies apply MDCG guidance consistently when assessing clinical evaluations, which means a CER that ignores the applicable MDCG guidance will generate findings at review even though the guidance is not law.

**What is MDCG 2020-5 and when does it apply?**
MDCG 2020-5 is the MDCG guidance on clinical evaluation equivalence, published in April 2020. It applies whenever a clinical evaluation report uses equivalence to a device from the same or another manufacturer as a data source. It defines how technical, biological, and clinical equivalence are assessed under MDR Annex XIV Part A Section 3 and is stricter than the equivalence approach in the legacy MEDDEV 2.7/1 Rev 4.

**What does MDCG 2023-7 actually clarify?**
MDCG 2023-7 clarifies the exemptions from the requirement to perform pre-market clinical investigations for implantable and Class III devices under MDR Article 61(4)-(6), and it defines what "sufficient levels of access" to clinical data means for equivalence claims between manufacturers. It was published in December 2023.

**Does MDCG guidance replace MEDDEV 2.7/1 Rev 4?**
Partially. MDCG 2020-5 replaces the equivalence treatment of MEDDEV 2.7/1 Rev 4 for MDR purposes. MDCG 2023-7 adds the Article 61(4)-(6) exemption framework that did not exist under the Directives. The four-stage clinical evaluation process discipline in MEDDEV 2.7/1 Rev 4 remains useful as methodological reference, but the substantive requirements for clinical evaluation under the MDR come from the Regulation and the MDCG guidance.

**Can a startup claim equivalence to a competitor device under the MDR?**
Only under strict conditions. MDCG 2020-5 sets the bar on technical, biological, and clinical equivalence, and MDCG 2023-7 requires ongoing contractual access to the competitor's clinical data and technical documentation where the claim is used to avoid a pre-market clinical investigation for an implantable or Class III device. Competitors rarely agree to this kind of contract, which means equivalence to a competitor device is the exception, not the default pathway for most startups.

**How often should MDCG documents be checked for new versions?**
Every clinical evaluation update. The MDCG publishes revisions periodically, and some documents have multiple revisions. MDCG 2019-11 on software classification is on Rev.1. MDCG 2023-3 on vigilance is on Rev.2. Checking the Commission website for the current version of every cited MDCG document is part of the CER update discipline.

## Related reading

- [MDR Article 61: Clinical Evidence Requirements](/blog/mdr-article-61-clinical-evidence-requirements-startups) – the article-by-article walkthrough of the core clinical evaluation obligation that MDCG guidance interprets.
- [What Is Clinical Evaluation Under MDR?](/blog/what-is-clinical-evaluation-under-mdr) – the Cat 3 pillar post and the starting point for the clinical evaluation cluster.
- [Clinical Evaluation Plan Under MDR](/blog/clinical-evaluation-plan-mdr) – the plan content mandated by Annex XIV Part A Section 1 and how MDCG guidance feeds into it.
- [Sufficient Clinical Evidence Under MDR](/blog/sufficient-clinical-evidence-mdr) – how to decide when evidence is actually sufficient for conformity assessment.
- [Equivalence Under MDR](/blog/equivalence-under-mdr) – the dedicated deep-dive on Annex XIV Part A Section 3 and MDCG 2020-5.
- [Clinical Evaluation Report Structure Under MDR](/blog/clinical-evaluation-report-structure-mdr) – how to structure a CER that cites the MDR text and MDCG guidance correctly.
- [Literature Review for MDR Clinical Evaluation](/blog/literature-review-mdr-clinical-evaluation) – where the MEDDEV 2.7/1 Rev 4 methodology still earns its place.
- [MEDDEV 2.7/1 Rev 4 Under MDR: Is It Still Relevant in 2026?](/blog/meddev-271-rev4-mdr-relevance) – the companion post on the legacy guidance and where MDCG now takes over.
- [Clinical Investigations Under MDR](/blog/clinical-investigations-under-mdr) – the pillar on the other side of the Article 61(4)-(6) exemption question.
- [MDCG Guidance Overview for MedTech Startups](/blog/mdcg-guidance-overview-medtech-startups) – the broader view of the MDCG guidance ecosystem beyond clinical evaluation.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) – the methodology pillar and the Evidence Pass that governs how guidance documents are applied in a lean CER.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 61 (clinical evaluation), Article 61(4)-(6) (clinical investigation exemptions for implantable and Class III devices), Annex XIV Part A (clinical evaluation), Annex XIV Part A Section 3 (equivalence conditions). Official Journal L 117, 5.5.2017.
2. MDCG 2020-5. Clinical Evaluation. Equivalence: A guide for manufacturers and notified bodies, April 2020.
3. 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.
4. MEDDEV 2.7/1 revision 4. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC, June 2016 (legacy guidance written for the former Directives; superseded by the MDR text and MDCG guidance wherever the two diverge).

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*This post is part of the Clinical Evaluation & Clinical Investigations cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. MDCG guidance is the layer between the Regulation and the notified body review, and reading it carefully is the difference between a clinical evaluation that survives first contact with a reviewer and one that does not.*

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*This post is part of the [Clinical Evaluation & Investigations](https://zechmeister-solutions.com/en/blog/category/clinical-evaluation) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*