---
title: MDR Annex XIV Part A: Clinical Evaluation Requirements
description: MDR Annex XIV Part A sets out the exact clinical evaluation process. Here is what each section requires — scope, data identification, appraisal, and analysis.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: MDR Annex XIV Part A
canonical_url: https://zechmeister-solutions.com/en/blog/mdr-annex-xiv-part-a-clinical-evaluation
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# MDR Annex XIV Part A: Clinical Evaluation Requirements

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

> **MDR Annex XIV Part A sets out the procedure manufacturers must follow for clinical evaluation under Article 61. It is structured in three sections: Section 1 on the clinical evaluation plan and scope definition, Section 2 on the identification, appraisal, and analysis of clinical data, and Section 3 on the conditions for demonstrating equivalence to another device. Together with Article 61, it defines both the process and the documentation — the clinical evaluation plan (CEP) and the clinical evaluation report (CER) — that every medical device on the EU market must have.**

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

---

## TL;DR

- Annex XIV Part A is the procedural annex for clinical evaluation under MDR Article 61. It defines the process, the plan, the stages of data handling, and the equivalence conditions.
- The structure is three sections: Section 1 (clinical evaluation plan and scope), Section 2 (data identification, appraisal, analysis, and clinical evaluation report), and Section 3 (equivalence).
- Clinical evaluation under Annex XIV Part A is a four-stage process: scope definition, identification of available clinical data, appraisal of each dataset, and analysis of the whole body of evidence against the safety and performance claims.
- The clinical evaluation plan is not optional. Annex XIV Part A Section 1(a) requires a documented plan before data is collected. Reverse-engineering a plan from already-collected data is a common finding at notified body review.
- Annex XIV Part A Section 3 defines equivalence on three dimensions — technical, biological, and clinical — that must all be met. MDCG 2020-5 (April 2020) is the authoritative interpretation.
- Post-market clinical follow-up (PMCF) sits in Annex XIV Part B and feeds updated data back into the Part A clinical evaluation throughout the life of the device.
- MEDDEV 2.7/1 Rev 4 (June 2016) remains a useful structural reference for the stages, but where it diverges from MDR text or MDCG 2020-5, the MDR text wins.

---

## Why Annex XIV Part A is the operational backbone of clinical evaluation

Article 61 tells you that clinical evaluation is mandatory, that it must be methodologically sound, and that it must be updated throughout the life of the device. It does not tell you how to actually run the process. That is what Annex XIV Part A is for.

If Article 61 is the "what," Annex XIV Part A is the "how." It is the annex the notified body reviewer opens when they read a clinical evaluation report and want to check whether the manufacturer did the work in the order and structure the Regulation prescribes. Tibor has seen clinical evaluation reports that skip entire sections of Annex XIV — most often the plan in Section 1(a) and the equivalence justification in Section 3 when equivalence is claimed. Those reports do not survive scrutiny. A CER that does not map section-for-section to Annex XIV Part A is a CER that will generate findings.

For a startup, reading Annex XIV Part A directly — not a summary, not a slide deck, the actual text of Regulation (EU) 2017/745 — is one of the highest-leverage hours you can spend on clinical evaluation. The annex is short. It is written in plain regulatory language. And it tells you exactly what a compliant clinical evaluation looks like.

## The structure of Annex XIV Part A in one paragraph

Annex XIV is split into Part A (Clinical evaluation) and Part B (Post-market clinical follow-up). Part A has three sections. Section 1 requires a documented clinical evaluation plan and defines its contents. Section 2 describes the process of identifying, appraising, and analysing clinical data, and defines what the clinical evaluation report must contain. Section 3 sets the conditions under which equivalence to another device may be claimed as part of the clinical data. That is the entire annex. Everything else in clinical evaluation — MDCG 2020-5, MDCG 2023-7, MEDDEV 2.7/1 Rev 4, EN ISO 14155:2020+A11:2024 — either interprets these three sections or governs a specific activity (like clinical investigations) that feeds into them.

## Annex XIV Part A Section 1 — the clinical evaluation plan

Section 1 of Annex XIV Part A requires the manufacturer to establish and update a clinical evaluation plan (CEP). The CEP is not a cover page. It is the structured document that governs the entire evaluation, and it must be written before the data is collected.

Annex XIV Part A Section 1(a) lists the content the clinical evaluation plan shall include, which in practice covers:

- An identification of the general safety and performance requirements (Annex I) that require support from relevant clinical data.
- A specification of the intended purpose of the device, as defined in Article 2(12), in language consistent with the labelling, the instructions for use, and the clinical evaluation itself.
- A specification of the intended target groups, with clear indications and contraindications.
- A detailed description of the intended clinical benefits to patients, with relevant and specified clinical outcome parameters.
- Methods to be used for examining qualitative and quantitative aspects of clinical safety, with clear reference to the determination of residual risks and side-effects.
- An indicative list and specification of parameters to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose.
- How benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues will be addressed.
- A clinical development plan for devices that require it, indicating progression from exploratory investigations (such as first-in-man studies, feasibility and pilot studies) through confirmatory investigations (such as pivotal clinical investigations) to a PMCF plan as referred to in Annex XIV Part B with an indication of milestones and a description of potential acceptance criteria.

If the CEP does not cover all of these, it is incomplete. Reviewers notice. The most common failures are vague intended purpose, missing acceptance criteria for the benefit-risk ratio, and a clinical development plan that reads like a list of hopes rather than a planned progression with milestones.

## Annex XIV Part A Section 2 — identification, appraisal, and analysis

Section 2 of Annex XIV Part A defines the core of the clinical evaluation: how clinical data is gathered, judged, and synthesised into a conclusion. In practice this maps to a four-stage process that has been used under the Directives (via MEDDEV 2.7/1 Rev 4) and carries into MDR with tighter language.

**Stage 1 — Scope definition.** Already handled in the CEP under Section 1(a). The scope defines what clinical questions the evaluation must answer: which GSPRs need clinical evidence, what the intended purpose is, which target groups, which clinical benefits, which risks.

**Stage 2 — Identification of available clinical data.** The manufacturer performs a systematic identification of clinical data from all relevant sources. Annex XIV Part A Section 1(a) explicitly refers to "favourable and unfavourable data" — the identification cannot cherry-pick supportive literature and ignore contradictory findings. Sources include scientific literature on the device and on the underlying technology, any clinical experience with the device already on the market, clinical data from devices claimed as equivalent (under Section 3), and results of clinical investigations performed on the device. The identification is documented, reproducible, and traceable — the reviewer must be able to re-run the search and get a comparable set.

**Stage 3 — Appraisal of each dataset.** Each piece of clinical data identified is appraised for its methodological quality, its relevance to the intended purpose and the clinical questions in the CEP, and its contribution to the evaluation. The appraisal criteria are pre-specified in the CEP — they are not invented after the data has been read. A weak retrospective single-centre case series gets weighted less than a well-powered prospective randomised investigation. Studies on a different indication or a different patient population get weighted according to their actual transferability, not wished-for transferability.

**Stage 4 — Analysis of the body of evidence.** The appraised data is analysed as a whole against the clinical claims, the intended purpose, the benefit-risk acceptability criteria from the CEP, and the state of the art. The analysis determines whether there is sufficient clinical evidence to demonstrate conformity with the relevant GSPRs. If there is, the evaluation concludes accordingly. If there is not, the evaluation identifies the gaps and the actions needed to close them — which is often where the decision to run a new clinical investigation under Articles 62 to 82 and EN ISO 14155:2020+A11:2024 enters the plan.

Section 2 also defines the output document: the clinical evaluation report (CER). The CER documents the data identified, the appraisal, the analysis, and the conclusions, and it references the CEP so the reader can verify that the evaluation was run according to the pre-specified plan. The CER is part of the technical documentation and is the document the notified body reviews during conformity assessment.

## Annex XIV Part A Section 3 — the equivalence conditions

Section 3 of Annex XIV Part A is the paragraph everyone who has ever considered an equivalence pathway needs to read word-for-word. It sets the conditions under which a manufacturer may claim that their device is equivalent to another device and therefore use the clinical data of that other device as part of their own clinical evaluation.

The conditions are grouped into three characteristics, and all three must be met:

**Technical characteristics.** The device has a similar design, is used under similar conditions of use, has similar specifications and properties — including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, and software algorithms — uses similar deployment methods where relevant, and has similar principles of operation and critical performance requirements.

**Biological characteristics.** The device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact, and with similar release characteristics of substances, including degradation products and leachables.

**Clinical characteristics.** The device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy, and physiology, has the same kind of user, and has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.

All three boxes must be ticked. Not two out of three. Not "close enough on the biological dimension." The MDR is explicit that the characteristics shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. For implantable and Class III devices, the conditions are even tighter — there must be a contract in place between the manufacturer of the device being evaluated and the manufacturer of the equivalent device that provides full ongoing access to the technical documentation, and both manufacturers must meet the equivalence criteria.

MDCG 2020-5 (April 2020) is the authoritative interpretation of Section 3. It is where the strictness of the MDR equivalence regime is made operational — particularly the difference from the more permissive MEDDEV 2.7/1 Rev 4 (June 2016) equivalence approach that was standard under the old Directives. Any equivalence claim under MDR that still follows the MEDDEV 2.7/1 Rev 4 logic without checking against MDCG 2020-5 is a claim that will not survive notified body review.

For the specific question of "sufficient levels of access" to the clinical data of the equivalent device for implantable and Class III devices, MDCG 2023-7 (December 2023) is the document to read alongside Section 3 and Article 61(4) to (6).

## The state of the art and why it sits across all three sections

"State of the art" is the phrase Annex XIV Part A uses to anchor the benefit-risk analysis, the equivalence comparison, and the acceptability of the clinical claims. Article 2(48) defines state of the art in the MDR context as the "developed stage of current technical capability and/or accepted clinical practice regarding products, processes and patient management, based on the relevant consolidated findings of science, technology and experience." It is not "state of the best." It is not "what is theoretically possible in an ideal world." It is the current accepted practice that a competent clinician or engineer would recognise as standard.

The state of the art must be identified and documented. It shows up in the CEP as the benchmark against which the benefit-risk ratio is assessed, in Section 2 as the context for appraising the relevance of each dataset, and in Section 3 as the frame of reference for equivalence. A CER that never defines the state of the art is a CER that has no benchmark for its conclusions. Reviewers ask for it explicitly.

## Common gaps Tibor sees in CERs against Annex XIV Part A

After reading a large number of clinical evaluation reports as both a consultant and a notified body lead auditor, the same structural gaps repeat:

- **Missing or weak clinical evaluation plan.** The CER is written first and a plan is retrofitted around it. The reviewer can tell because the appraisal criteria suspiciously fit the data.
- **Intended purpose that does not match the labelling.** The CEP states one intended purpose, the label implies a broader one, and the clinical evidence covers only part.
- **No state of the art definition.** The CER jumps straight to the device's own data without establishing what current accepted practice looks like.
- **Equivalence claims that only meet one or two of the three characteristics in Section 3.** Typically the technical and clinical boxes are ticked and the biological box is hand-waved.
- **No PMCF plan link back to the clinical evaluation.** Annex XIV Part B sits outside Part A, but the feedback loop is explicit in Article 61(3). CERs that end without referencing the PMCF plan are incomplete.
- **Appraisal criteria invented after the fact.** The inclusion and exclusion criteria in the literature search read as if they were chosen to keep favourable studies in and unfavourable studies out.
- **Clinical development plan reduced to a sentence.** Section 1(a) requires a clinical development plan with milestones and acceptance criteria where applicable; a single paragraph saying "we will conduct a PMCF study" does not meet that requirement.

Each of these is a gap that is cheap to fix at the CEP stage and expensive to fix at the notified body review stage.

## The Subtract to Ship angle on Annex XIV Part A

Subtract to Ship applied to Annex XIV Part A is disciplined, not permissive. Every section of the annex that applies to your device must be addressed — there is nothing to subtract from the Regulation itself. What you can subtract is the work that does not actually trace to a specific requirement in Section 1, Section 2, or Section 3.

The subtraction happens in three places. First, in the CEP scope: identify which GSPRs genuinely require clinical data and do not write a clinical evaluation for the ones that do not. Second, in the data sources: evaluate literature and existing clinical experience under Section 2 before defaulting to new clinical investigations, because Section 2 treats all sources as legitimate inputs and the cheapest adequate source is the one that should carry the evidence. Third, in the equivalence assessment: if all three characteristics in Section 3 can be met honestly, the equivalence route can remove an entire clinical investigation from the plan; if they cannot, do not force it, because a failed equivalence claim costs more than it saves.

The discipline is the same one described in the pillar post. Nothing is added that does not trace to a specific subsection of Annex XIV Part A. Nothing required by Annex XIV Part A is skipped. The result is a clinical evaluation that is smaller than the bloated default and fully defensible at notified body review.

## Reality Check — Where do you stand on Annex XIV Part A?

1. Do you have a clinical evaluation plan that was written before data collection began, and does it include every item listed under Annex XIV Part A Section 1(a)?
2. Is your intended purpose identical in the CEP, the label, the IFU, and the CER, or do the four documents quietly diverge?
3. Have you identified which specific GSPRs in Annex I actually require clinical data to be demonstrated, and is that identification documented in the CEP?
4. Have you defined the state of the art for your device's clinical application, and can you cite the sources for that definition?
5. Is your literature search reproducible — can another competent reviewer re-run it and arrive at a comparable set of sources?
6. Are your appraisal criteria pre-specified in the CEP, not reverse-engineered from the data you found?
7. If you are claiming equivalence, have you mapped your device against the equivalent device on all three dimensions in Annex XIV Part A Section 3 — technical, biological, and clinical — and can you defend every box honestly?
8. If you are an implantable or Class III manufacturer claiming equivalence, have you read MDCG 2023-7 and do you have the contractual access to the equivalent device's data that Article 61(4) to (6) requires?
9. Does your CER reference the CEP section-by-section so the reviewer can verify the evaluation was run according to the pre-specified plan?
10. Is your PMCF plan under Annex XIV Part B written and linked back to the Part A clinical evaluation, so the feedback loop Article 61(3) requires is actually in place?

## Frequently Asked Questions

**What is MDR Annex XIV Part A?**
Annex XIV Part A of Regulation (EU) 2017/745 is the annex that sets out the procedure manufacturers must follow for clinical evaluation under Article 61. It has three sections: Section 1 on the clinical evaluation plan, Section 2 on the identification, appraisal, and analysis of clinical data and the clinical evaluation report, and Section 3 on the conditions for claiming equivalence to another device.

**What is the difference between Annex XIV Part A and Annex XIV Part B?**
Part A covers clinical evaluation — the pre-market and ongoing process of establishing that the device has sufficient clinical evidence to demonstrate conformity with the general safety and performance requirements. Part B covers post-market clinical follow-up (PMCF) — the structured post-market data collection that feeds updated clinical data back into the Part A evaluation throughout the life of the device.

**Does Annex XIV Part A require a clinical evaluation plan for every device?**
Yes. Annex XIV Part A Section 1(a) requires a documented clinical evaluation plan with specified content. The requirement applies regardless of device class. The depth and extent of the plan scale with the risk and novelty of the device, but the existence of a written plan is not optional.

**What are the three equivalence characteristics in Annex XIV Part A Section 3?**
Technical, biological, and clinical. All three must be met. Technical covers design, specifications, and principles of operation. Biological covers materials in contact with tissues and their release characteristics. Clinical covers the condition treated, the site in the body, the patient population, the user, and the expected clinical performance. MDCG 2020-5 (April 2020) is the authoritative interpretation of how each characteristic is assessed under MDR.

**Is MEDDEV 2.7/1 Rev 4 still valid for MDR clinical evaluation?**
MEDDEV 2.7/1 Rev 4 (June 2016) is legacy guidance written under the former Directives. It remains useful as a structural reference for the four-stage process, but where it diverges from the MDR text or from MDCG 2020-5, the MDR text and the MDCG guidance take precedence. In particular, the MEDDEV 2.7/1 Rev 4 equivalence approach is more permissive than Annex XIV Part A Section 3 and should not be used as the sole reference for MDR equivalence claims.

**What is the clinical evaluation report (CER) and where is it defined?**
The CER is the output document of the clinical evaluation process. Its required content is defined by Annex XIV Part A Section 2 and by Article 61. It documents the data identified, the appraisal, the analysis, and the conclusions, references the clinical evaluation plan, and forms part of the technical documentation submitted for conformity assessment.

**How does Annex XIV Part A interact with clinical investigations under Articles 62 to 82?**
Clinical investigations under Articles 62 to 82 and Annex XV, conducted in accordance with EN ISO 14155:2020+A11:2024, are one of the sources of clinical data that feed the Annex XIV Part A evaluation. Annex XIV Part A governs how that data is handled inside the clinical evaluation; Articles 62 to 82 and Annex XV govern how the investigation itself is conducted. The two annexes work together and should not be confused.

## Related reading

- [What Is Clinical Evaluation Under MDR?](/blog/what-is-clinical-evaluation-under-mdr) — the pillar post for the Clinical Evaluation cluster and the starting point for the whole topic.
- [MDR Article 61 Clinical Evaluation Requirements](/blog/mdr-article-61-clinical-evaluation-requirements) — the article-by-article walkthrough that sits above Annex XIV Part A in the regulatory hierarchy.
- [The Clinical Evaluation Plan: What Annex XIV Part A Section 1 Requires](/blog/clinical-evaluation-plan-mdr) — the dedicated deep-dive on the CEP content requirements.
- [Clinical Evaluation Report Structure Under MDR](/blog/clinical-evaluation-report-structure-mdr) — how to structure the CER so it mirrors Annex XIV Part A section by section.
- [Literature Review for MDR Clinical Evaluation](/blog/literature-review-mdr-clinical-evaluation) — the practical methodology for Stage 2 data identification and appraisal.
- [Appraisal of Clinical Data Under MDR](/blog/appraisal-clinical-data-mdr) — how to pre-specify and apply appraisal criteria without reverse-engineering them.
- [Analysis of Clinical Data and Sufficient Evidence](/blog/analysis-clinical-data-sufficient-evidence) — the Stage 4 synthesis against the CEP acceptance criteria.
- [Equivalence Under MDR](/blog/equivalence-under-mdr) — the dedicated deep-dive on Annex XIV Part A Section 3 and MDCG 2020-5.
- [Post-Market Clinical Follow-Up (PMCF) Under MDR Annex XIV Part B](/blog/pmcf-mdr-annex-xiv-part-b) — the Part B counterpart that closes the clinical evaluation loop.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) — the methodology pillar, including the Evidence Pass that governs how Annex XIV Part A is applied under startup constraints.

## 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 2(48) (state of the art), Article 61 (clinical evaluation), Annex I (general safety and performance requirements), Annex XIV Part A Sections 1 to 3 (clinical evaluation), Annex XIV Part B (post-market clinical follow-up). 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; MDR text and MDCG 2020-5 take precedence where they diverge).
5. EN ISO 14155:2020 + A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice.

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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. Annex XIV Part A is short enough to read in an hour and strict enough to shape the next year of your clinical evaluation work — the hour is the highest-leverage hour in the whole cluster.*

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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).*