---
title: What Is Clinical Evaluation Under MDR? The Foundation
description: Clinical evaluation is the ongoing process of generating, collecting, and assessing clinical data on safety and performance. Here is what MDR Article 61 actually requires.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: clinical evaluation MDR
canonical_url: https://zechmeister-solutions.com/en/blog/what-is-clinical-evaluation-under-mdr
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# What Is Clinical Evaluation Under MDR? The Foundation

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

> **Clinical evaluation under MDR is a systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device, in order to verify its safety, performance, and clinical benefits when used as intended by the manufacturer. It is not a single report written once at the end of development. It is an ongoing lifecycle activity defined by MDR Article 61 and Annex XIV, and it is the backbone of clinical evidence for every medical device placed on the EU market.**

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

---

## TL;DR

- Clinical evaluation is a lifecycle process, not a document. The clinical evaluation report (CER) is the output of the process at a point in time; the process itself never stops.
- MDR Article 61 and Annex XIV Part A govern clinical evaluation. Annex XIV Part B governs post-market clinical follow-up (PMCF), which feeds updated data back into the evaluation.
- Clinical evaluation draws on three data sources: scientific literature, clinical experience with an equivalent device, and clinical investigation of the device itself. The choice between them drives most of the cost and timeline.
- Clinical investigation is only one of those three sources. For many devices, especially those using well-established methods, literature and existing harmonised standards can carry most of the clinical evaluation MDR burden.
- A Graz-based company we worked with saved EUR 400,000-500,000 and 1-1.5 years by recognising that their established measurement methods were already covered by recognised standards, removing the need for pre-market clinical investigations on those aspects.
- Intended purpose, as defined in MDR Article 2(12), determines the evidence burden. Change the intended purpose and the clinical evaluation changes with it.
- MDCG 2023-7 (December 2023) clarifies the four cases in which implantable and Class III devices may be exempted from mandatory pre-market clinical investigations under Article 61(4)-(6).

---

## The story: how a Graz company saved EUR 400,000-500,000 by reading the standards first

A company in Graz came to us with an innovative product built around two measurement methods. The methods themselves were not new. They were established in the scientific and engineering literature, codified in recognised standards, and used across the industry for years. What was new was the combination and the clinical use case.

Their original plan followed the instinct most founders have when they hear the words "clinical evaluation MDR" for the first time. Run clinical investigations. Two or three of them. Recruit patients, set up sites, fund a statistician, write protocols under EN ISO 14155:2020+A11:2024, submit to ethics committees, wait. The budget they had in mind was the kind of number that turns a startup runway into a single line of spreadsheet. One and a half years. Four to five hundred thousand euros. Maybe more.

The Evidence Pass asked a different question. Before you default to the most expensive pathway, exhaust the cheaper ones. Do the measurement methods have existing scientific validation in the literature? Yes. Are they covered by harmonised standards that already carry presumption of conformity for the specific performance characteristics in question? Yes. Is there a legitimate argument that the clinical performance of these established methods does not need to be re-demonstrated from scratch in a new clinical investigation, as long as the specific application is addressed?

The argument held. The Notified Body accepted it. The company saved EUR 400,000-500,000 and 1-1.5 years. Not by cutting corners. Not by ignoring MDR Article 61. By reading Annex XIV Part A carefully, assembling the literature and standards-based evidence in a clinical evaluation plan that was honest about what was already known, and addressing only the genuinely novel aspects through other means.

This is the Cat 3 pillar lesson in one sentence. Clinical evaluation is not a synonym for "run a clinical investigation." It is a structured process with three legitimate data sources, and the choice between them is where startups save or lose their runway.

## What clinical evaluation actually is (and what it is not)

Clinical evaluation is defined in MDR Article 2(44) as "a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer." Two words in that definition do most of the work: "continuously" and "process."

Clinical evaluation is continuous. It does not end when CE marking is granted. It continues through the entire lifecycle of the device, fed by PMCF data, by complaint handling, by literature updates, by new scientific knowledge about the condition or the technology. A clinical evaluation report that is frozen in time is a clinical evaluation report that is already out of date.

Clinical evaluation is a process. It is not a single document. It has a plan (the clinical evaluation plan, CEP), inputs (clinical data from the three sources), methods (appraisal and analysis), outputs (the clinical evaluation report, CER), and feedback loops (PMCF data flowing back into the next update). The process is owned by the manufacturer, reviewed by the Notified Body where applicable, and must be traceable end-to-end in the technical documentation.

Clinical evaluation is **not** the same as clinical investigation. This distinction trips up every founder who encounters the topic for the first time, and it matters enormously for cost and timeline.

A clinical investigation is a specific study, conducted with human subjects, on the device itself, under a protocol, with ethics approval, following the good clinical practice requirements of EN ISO 14155:2020+A11:2024 and MDR Articles 62-82 and Annex XV. It is one possible source of clinical data. It is not the only one, and for many devices it is not the primary one.

Clinical evaluation is the broader process that may or may not include a clinical investigation, depending on what evidence already exists. A Class I device with a long-established measurement principle may go through clinical evaluation without running a single clinical investigation. A novel Class III implantable may require several. The question "do I need a clinical investigation?" is the wrong first question. The right first question is "what clinical data already exists, and is it sufficient?"

## The three data sources: literature, equivalence, clinical investigation

MDR Annex XIV Part A describes the clinical evaluation process and the data sources that feed it. In practice, every piece of clinical data that enters a CER comes from one of three places.

**Source 1. Scientific literature.** Published peer-reviewed literature on the device, on devices of the same generic group, on the underlying technology, on the clinical condition, or on the established measurement methods the device relies on. Literature review is structured, documented, and reproducible. The appraisal criteria must be pre-specified in the clinical evaluation plan. This is the pathway that carried most of the clinical evidence burden in the Graz story. It is also the pathway that is consistently under-used by startups who assume clinical evidence means new clinical trials.

**Source 2. Equivalence to an existing device.** If the manufacturer can demonstrate that their device is equivalent to a device already on the market, with sufficient clinical data, that data may be used to support the clinical evaluation of the new device. Equivalence under MDR is strict. The equivalence claim must cover three dimensions. Technical, biological, and clinical characteristics. And the manufacturer must have sufficient levels of access to the clinical data of the equivalent device to justify the claim. MDCG 2020-5 (Clinical Evaluation. Equivalence: A guide for manufacturers and notified bodies, April 2020) is the authoritative interpretation document for this pathway. It is stricter than the equivalence approach that was common under the old Directives and the legacy MEDDEV 2.7/1 Rev 4 (June 2016) guide. Under MDR, equivalence is possible but not easy, particularly for implantable and Class III devices where "sufficient levels of access" to data is further clarified by MDCG 2023-7.

**Source 3. Clinical investigation of the device itself.** A study on the device conducted under EN ISO 14155:2020+A11:2024 and the MDR provisions in Articles 62-82 and Annex XV. This is the most expensive, most time-consuming, and most logistically demanding source. It is also sometimes unavoidable. For novel Class III devices, for most implantable devices, and wherever the first two sources do not produce sufficient clinical evidence. The question is never "should we avoid clinical investigations" but "should we run clinical investigations for the parts of the evidence burden that literature and equivalence cannot cover."

The three sources are not mutually exclusive. A well-built CER typically draws on all three to different extents. The clinical evaluation plan specifies, in advance, how each source will be used, what questions each one is expected to answer, and what the appraisal criteria will be.

## The lifecycle: CEP, CER, and the PMCF feedback loop

Clinical evaluation under MDR is structured as a plan-do-check-act loop that runs for the life of the device.

**The clinical evaluation plan (CEP).** Before any data is collected, the manufacturer writes a CEP. The CEP defines the scope of the evaluation, the intended purpose of the device (referencing the Article 2(12) definition), the intended target population and indications, the clinical benefits and clinical performance claims to be substantiated, the acceptance criteria for conformity with the relevant general safety and performance requirements, the data sources to be used, the appraisal methodology, and the analysis methodology. Annex XIV Part A paragraph 1 sets out the required content of the CEP. A startup that skips the CEP and starts writing the CER directly is building on sand. The appraisal criteria must be pre-specified, not reverse-engineered to fit the data you happen to have found.

**The clinical evaluation report (CER).** The CER is the output document of the clinical evaluation process at the point when conformity with the general safety and performance requirements needs to be demonstrated. Typically at the pre-market conformity assessment. The CER documents the data collected, the appraisal, the analysis, and the conclusions about safety, performance, and clinical benefits. It references the CEP and demonstrates that the evaluation was conducted according to the pre-specified plan.

**The PMCF feedback loop.** Annex XIV Part B governs post-market clinical follow-up. PMCF is the active, continuous process of collecting clinical data on the device after it is on the market, in order to confirm safety and performance throughout the expected lifetime, identify previously unknown risks, monitor known side-effects, ensure the continued acceptability of the benefit-risk ratio, and identify possible systematic misuse or off-label use. PMCF data feeds back into the clinical evaluation, which is updated periodically. The cadence of updates depends on the risk class and the nature of the device. More frequent for higher-risk and novel devices, less frequent for well-established lower-risk ones, but never "never."

The lifecycle loop is why clinical evaluation cannot be treated as a one-shot document. A CER that is written once and then filed away is a CER that fails at the first PMS review cycle.

## How intended purpose drives the evidence burden

The single most leveraged sentence in the entire MDR sits in Article 2(12). Intended purpose is "the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials or statements, and as specified by the manufacturer in the clinical evaluation."

Read that definition twice. The intended purpose is not a marketing claim. It is not what the founder hopes the device will do someday. It is the specific, documented use for which the device is being placed on the market, as reflected in the labelling, the IFU, the sales materials, and. Critically. The clinical evaluation itself. Change any of those, and the intended purpose has changed, and the clinical evidence burden changes with it.

This is why the first pass of any clinical evaluation project is an honest look at the intended purpose. The narrower and more specific the intended purpose, the more focused the clinical evaluation can be. The broader and vaguer the intended purpose, the more evidence is needed to cover every claim implied by the breadth. Founders who load the IFU with every possible future indication are not future-proofing the product. They are multiplying the clinical evaluation cost, sometimes by orders of magnitude.

The Graz story worked because the intended purpose was tightly defined and honest about what the device did, and the established measurement methods mapped cleanly onto that defined purpose. If the same device had been marketed with a broader set of claims, the literature pathway might not have carried the weight, and clinical investigations would have become unavoidable for the uncovered claims.

## What MDR Article 61 actually requires

MDR Article 61 is the core provision for clinical evaluation. Paragraph 1 establishes the basic obligation: confirmation of conformity with the relevant general safety and performance requirements under the conditions of normal use of the device, evaluation of undesirable side-effects and of the acceptability of the benefit-risk ratio, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III. The manufacturer specifies and justifies the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements, taking into account the characteristics of the device and its intended purpose.

Paragraph 2 requires the clinical evaluation to follow a defined and methodologically sound procedure based on a critical evaluation of the relevant scientific literature, a critical evaluation of the results of all available clinical investigations, and consideration of currently available alternative treatment options. Annex XIV Part A spells out how this procedure is structured in practice.

Paragraph 3 requires the clinical evaluation and its documentation to be updated throughout the life cycle of the device with clinical data obtained from the implementation of the PMCF plan and the post-market surveillance plan. For Class III and implantable devices, the CER is updated at least annually with data from the PMCF.

Paragraphs 4, 5, and 6 address clinical investigations specifically. Paragraph 4 establishes the general rule that for implantable devices and for Class III devices, clinical investigations shall be performed, with specific exemptions. Paragraphs 5 and 6 define those exemptions. MDCG 2023-7 (December 2023) is the authoritative guidance on how Article 61(4)-(6) is interpreted in practice, including what "sufficient levels of access" to data means for equivalence-based exemptions.

Paragraph 10 addresses the situation where clinical data is not deemed appropriate to demonstrate conformity with the GSPRs. In that case, the manufacturer must duly substantiate, based on the results of the risk management process and on the specifics of the device-body interaction, the clinical performance intended, and the claims of the manufacturer, why demonstration of conformity with the GSPRs based on clinical data alone is not deemed appropriate. This is a narrow escape valve, not a general exemption, and Notified Bodies scrutinise its use carefully.

## When you can avoid pre-market clinical investigations: MDCG 2023-7

The question every founder of an implantable or Class III device asks is whether they can avoid a full pre-market clinical investigation. The answer is "sometimes, under specific conditions defined in MDR Article 61(4)-(6) and clarified in MDCG 2023-7 (December 2023)."

MDCG 2023-7 addresses four cases in which implantable and Class III devices may be exempted from the general requirement to perform pre-market clinical investigations:

**Case 1. Modifications to a device already marketed by the same manufacturer.** When a new version of a device is modified from a predecessor device that the same manufacturer has already placed on the market, and the manufacturer has demonstrated that the new version is equivalent to the marketed device, and the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified version with the relevant safety and performance requirements.

**Case 2. Equivalence to a device marketed by another manufacturer.** When the device for which clinical evaluation is being carried out is demonstrated to be equivalent to a device already marketed by another manufacturer, subject to very specific conditions including sufficient levels of access to the full technical documentation of the equivalent device on an ongoing basis, via a contract between the two manufacturers. The "sufficient levels of access" requirement is the part MDCG 2023-7 clarifies in the most practical detail.

**Case 3. Devices lawfully placed on the market under the Directives.** For devices that have been lawfully placed on the market under the former Directives and for which clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific common specifications, where such common specifications are available.

**Case 4. Certain well-established technologies.** In specific limited situations where the Article 61(6)(b) conditions are met, relating to devices consisting of sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, or connectors, for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific common specifications, where such common specifications are available.

The four cases are narrow. They are not loopholes (and we would not use that word anyway. It is a dangerous framing for regulated products). They are specific legal pathways defined by the Regulation and clarified by the MDCG. For most startups building genuinely novel implantable or Class III devices, the four cases will not apply, and pre-market clinical investigation will be part of the clinical evaluation strategy. For the subset where they do apply, the savings are measured in years and hundreds of thousands of euros.

For devices that are **not** implantable and **not** Class III. The majority of startup devices. Article 61(10) and the broader Article 61 framework already allow clinical evaluation without clinical investigation, provided sufficient clinical evidence can be built from literature, equivalence, and other sources. The Graz story sits in this broader space. The company did not need an exemption under 61(4)-(6); they simply built their clinical evaluation from sources that did not require new clinical investigations.

## The PMCF loop: why clinical evaluation never ends

Annex XIV Part B defines the PMCF plan and the PMCF evaluation report. PMCF is the continuous, structured collection of clinical data on the device after it is placed on the market, and the data flows directly back into the clinical evaluation.

For most startups, PMCF is an afterthought during the pre-market phase. Something that becomes real only after the CE mark is in hand. This is a mistake. The PMCF plan must be written before CE marking (it is part of the technical documentation), and the methods chosen in the PMCF plan have to be feasible, proportionate, and aligned with the clinical evaluation strategy from day one. A PMCF plan that promises elaborate post-market studies the company cannot fund is a plan that will fail at the first PMS review.

PMCF methods can include ongoing literature surveillance, registry participation, user surveys, focused post-market studies, and structured complaint analysis. The choice depends on the device class, the novelty of the technology, the nature of the clinical claims, and the resources of the manufacturer. The same Subtract to Ship logic applies: do not promise PMCF activities that do not trace to a specific Annex XIV Part B requirement, and do not skip the ones that do.

The PMCF feedback loop is what turns clinical evaluation into a living process. Data flows in from PMCF. The CER is updated. New risks are identified, risk management under EN ISO 14971:2019+A11:2021 is updated, the benefit-risk ratio is re-assessed, the labelling and IFU may change, the next PMCF cycle is planned accordingly. Every loop of the cycle is documented and traceable.

## The Subtract to Ship angle: the Evidence Pass

Clinical evaluation is where the Evidence Pass of the Subtract to Ship framework produces its largest savings. The Evidence Pass asks one question: what is the minimum clinical evidence needed to demonstrate conformity, and what is the cheapest legitimate pathway to that evidence?

The pass runs in a specific order. First, define the intended purpose tightly, honestly, and in a form that matches the clinical evaluation. Second, identify the specific GSPRs that need clinical evidence to support them. Not all of them do. Third, for each required piece of evidence, evaluate the three data sources in order of cost: literature first, equivalence second, clinical investigation last. Fourth, assemble the clinical evaluation plan around the cheapest combination of sources that genuinely answers the questions. Fifth, only then design the clinical investigation activities needed to close the gaps the first three sources cannot close.

The Graz story is a textbook Evidence Pass. The company started with the assumption that clinical investigation was the pathway. The Evidence Pass reversed the order. Literature first. Established-method standards second. Equivalence where applicable. Clinical investigation only for genuinely novel aspects. The result was a clinical evaluation that satisfied MDR Article 61 and Annex XIV Part A, withstood Notified Body scrutiny, and cost a fraction of the original plan.

The Evidence Pass is not a permission slip to avoid required work. Clinical investigation is sometimes the only source that can answer a specific question, and when it is, the investigation happens. The pass is a discipline for not defaulting to the most expensive pathway before the cheaper ones have been properly evaluated. That discipline, applied honestly, is the single highest-leverage move in clinical evaluation MDR strategy for resource-constrained startups.

## Reality Check. Where do you stand?

1. Can you write the intended purpose of your device in one sentence, in language that would appear on the label and IFU exactly as written?
2. Have you identified which specific general safety and performance requirements in Annex I actually need clinical evidence to be demonstrated, and which are supported by other means?
3. Do you have a written clinical evaluation plan (CEP), or are you planning to write the clinical evaluation report (CER) directly from whatever data you happen to have?
4. For each piece of clinical evidence you expect to need, have you evaluated all three data sources. Literature, equivalence under MDCG 2020-5, and clinical investigation. In order of cost before committing to one?
5. If your device is implantable or Class III, have you read MDCG 2023-7 and determined whether any of the four exemption cases under Article 61(4)-(6) apply to your situation?
6. Have you drafted a PMCF plan that is actually feasible within your resources, or does your PMCF plan contain activities the company cannot fund?
7. Is your clinical evaluation linked to your risk management process under EN ISO 14971:2019+A11:2021, so that PMCF findings flow into both the next CER update and the next risk file update?
8. Do you understand how the equivalence route under MDCG 2020-5 actually works, and can you state honestly whether you have "sufficient levels of access" to the clinical data of the device you want to claim equivalence to?
9. If you are building a novel Class III or implantable device and none of the MDCG 2023-7 exemptions apply, have you started planning the clinical investigation under EN ISO 14155:2020+A11:2024 early enough that it will not become the critical path of your whole MDR project?
10. When was the last time you subtracted a piece of evidence from your clinical evaluation plan because it was not needed, rather than adding one because it "looked thorough"?

## Frequently Asked Questions

**What is the difference between clinical evaluation and clinical investigation under MDR?**
Clinical evaluation is the overall process of generating, collecting, analysing, and assessing clinical data to verify the safety and performance of a device, defined in MDR Article 2(44) and Articles 61 / Annex XIV Part A. Clinical investigation is a specific type of study on human subjects conducted on the device itself, governed by MDR Articles 62-82 and Annex XV and by EN ISO 14155:2020+A11:2024. Clinical investigation is one possible input to clinical evaluation; clinical evaluation is the broader process that may or may not include a clinical investigation depending on the evidence needed.

**Does every medical device need a clinical investigation under MDR?**
No. Every medical device needs a clinical evaluation under MDR Article 61. Not every medical device needs a clinical investigation. Devices that are not implantable and not Class III can often build sufficient clinical evidence from literature, equivalence, and existing data without running a new clinical investigation. For implantable and Class III devices, clinical investigations are required as a general rule under Article 61(4), with specific exemptions defined in Article 61(5)-(6) and clarified in MDCG 2023-7.

**What is a clinical evaluation report (CER)?**
The CER is the output document of the clinical evaluation process. It documents the clinical evaluation plan, the data collected from the three sources (literature, equivalence, clinical investigation), the appraisal and analysis of that data, and the conclusions about safety, performance, and clinical benefits of the device. The CER is part of the technical documentation submitted for conformity assessment and is updated throughout the life of the device based on PMCF data.

**Can a startup use literature review as the main source of clinical evidence under MDR?**
Yes, for many devices, particularly those based on well-established measurement methods or technologies with substantial published clinical experience. Literature review must be structured, pre-specified in the clinical evaluation plan, and conducted with documented appraisal criteria. The feasibility of a literature-dominated clinical evaluation depends on the device, the intended purpose, the risk class, and the availability of directly relevant published data. The Graz case described in this post is an example of a literature-and-standards-dominated approach that worked.

**What is MEDDEV 2.7/1 Rev 4 and is it still relevant under MDR?**
MEDDEV 2.7/1 Rev 4 (June 2016) is the legacy guidance on clinical evaluation under the former Directives 93/42/EEC and 90/385/EEC. It remains a widely referenced structural guide for how to organise a clinical evaluation, but the MDR text takes precedence wherever the two diverge. For equivalence specifically, MDCG 2020-5 has updated the MEDDEV approach and is the authoritative MDR-era reference. Treat MEDDEV 2.7/1 Rev 4 as a useful historical structure, not as current binding interpretation.

**How often does the clinical evaluation report need to be updated?**
The clinical evaluation is updated throughout the life of the device based on PMCF data and other new information, as required by MDR Article 61(3). For Class III and implantable devices, the CER must be updated at least annually. For lower-risk devices, the update frequency is defined in the PMS and PMCF plans, proportionate to the risk and the novelty of the device.

**What does "sufficient levels of access" mean for equivalence claims under MDR?**
For equivalence claims, especially for implantable and Class III devices, the manufacturer claiming equivalence must have access to the clinical data and technical documentation of the equivalent device at a level sufficient to genuinely support the equivalence argument. MDCG 2023-7 (December 2023) clarifies that this typically requires an ongoing contractual relationship between the manufacturers, not a one-off data purchase. The bar is high, and Notified Bodies scrutinise equivalence claims carefully under MDR. More carefully than they did under the Directives.

## Related reading

- [What Is the EU Medical Device Regulation?](/blog/what-is-eu-mdr) – the pillar post for MDR fundamentals and the starting point if you are new to the Regulation.
- [MDR Article 61 Clinical Evidence Requirements for Startups](/blog/mdr-article-61-clinical-evidence-requirements-startups) – the article-by-article walkthrough of what Article 61 obliges you to do.
- [Sufficient Clinical Evidence Under MDR](/blog/sufficient-clinical-evidence-mdr) – how to decide when your clinical evidence is actually sufficient for conformity assessment.
- [The Two-Phase Development Approach](/blog/two-phase-development-approach) – the time-axis framing that keeps clinical evaluation aligned with product development.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) – the methodology pillar, including the Evidence Pass referenced in this post.
- [MDR Article 61 Clinical Evaluation Requirements](/blog/mdr-article-61-clinical-evaluation-requirements) – deeper breakdown of the individual paragraphs of Article 61.
- [Clinical Evaluation vs Clinical Investigation](/blog/clinical-evaluation-vs-clinical-investigation) – a dedicated comparison post for the distinction that trips up most founders.
- [The Clinical Evaluation Process Under MDR](/blog/clinical-evaluation-process-mdr) – the step-by-step process walkthrough from CEP to CER to PMCF update.
- [MDR Annex XIV Part A: Clinical Evaluation Explained](/blog/mdr-annex-xiv-part-a-clinical-evaluation) – the annex walkthrough that sits underneath Article 61.
- [Equivalence Under MDR](/blog/equivalence-under-mdr) – the dedicated deep-dive on the equivalence pathway and MDCG 2020-5.
- [Sufficient Clinical Evidence for Class I Devices](/blog/sufficient-clinical-evidence-class-i-devices) – the Class I-specific application of the clinical evidence rules.
- [What Is a Clinical Investigation Under MDR?](/blog/what-is-clinical-investigation-mdr) – the pillar on the other side of the distinction: when a clinical investigation is the right answer.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 2(12) (intended purpose), Article 2(44) (clinical evaluation), Article 61 (clinical evaluation), Articles 62-82 (clinical investigations), Annex XIV Part A (clinical evaluation), Annex XIV Part B (post-market clinical follow-up), Annex XV (clinical investigations). 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, still referenced for structural approach; MDR text takes precedence where they diverge).
5. EN ISO 14155:2020 + A11:2024. Clinical investigation of medical devices for human subjects. Good clinical practice.
6. EN ISO 14971:2019 + A11:2021. Medical devices. Application of risk management to medical devices.

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*This post is the pillar for the Clinical Evaluation & Clinical Investigations cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Clinical evaluation is the part of MDR where the difference between a well-designed strategy and a defaulted one is measured in years of runway. And where the right expert sparring partner is often the difference between a CER that survives Notified Body review 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).*