Section C (part 1) — Device description and classification
Source: MDCG-2020-01.pdf pages 8-12 (document: MDCG 2020-13)
(PDF page 8 continues Section B: Reviewers involved in the notified body assessment of the clinical evaluation. Section C begins on PDF page 9.)
Section C: Device description, classification, clinical evaluation plan, information materials supplied by the manufacturer, common specifications and harmonised standards applied, equivalence and state of the art
Device description
Describe the device and comment on the intended purpose, including:
- The intended patient population and medical conditions to be diagnosed, treated and/or monitored.
- A general description of the key functional elements: its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition.
- The principles of operation of the device and its mode of action; explanation of any novel features.
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Classification
List the applicable classification rule(s) and indents.
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Device configurations/variants included in this application:
Include the manufacturers description of the sizes, differences in design features, different configurations etc.
Include an image of the device where possible.
If applicable, include the manufacturers description of the device history and/or changes in the device since its last assessment.
Where relevant, include the manufacturers description of the reason for differences in design variants with illustrative images where possible.
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Accessories or compatible devices:
Describe any accessories or compatible devices if any or state, "none").
Include component devices in case of system/procedure pack.
If the use of accessories or compatible devices has an impact on clinical safety or performance or the scope or validity of the clinical evaluation, identify this here.
If it is necessary to understand the usage of the device, include images or other relevant information such as diagrams.
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Previous generations of the device and similar devices (if applicable):
Verify that the manufacturer has provided:
- an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist.
- an overview of identified similar devices available on the Union or international markets, where such devices exist, including length of time on the market, sales volume etc.
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Non-compliances identified and resolved for this section may be briefly described in this box
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Device details, intended purpose and classification are:
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Compliant with the applicable requirements of the MDR:
Include any relevant comments
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Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:
Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.
Clinical evaluation plan
Briefly summarise the manufacturer's clinical evaluation plan and confirm that it meets the requirements of Annex XIV Part A Section 1a, highlighting the areas which require particular attention for this assessment:
- an identification of the general safety and performance requirements that require support from relevant clinical data;
- a specification of the intended purpose of the device;
- a clear specification of intended target groups with clear indications and contra-indications;
- a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
- a specification of methods to be used for examination of 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 be used 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 or purposes of the device;
- an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
- a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of Annex XIV of MDR, with an indication of milestones and a description of potential acceptance criteria.
A detailed description of the clinical development plan is not required for the purpose of this template unless there are specific concerns.
Add the manufacturer's reference and version and date of the clinical evaluation plan.
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Clinical performance
Summarise the clinical data to demonstrate the ability of the device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.
Describe the clinical benefits.
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Safety
Does the clinical evaluation adequately addresses the qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and undesirable side-effects and the confirmation of the relevant safety and performance requirements provided for in Annex I?
Summarise the clinical data regarding safety, and also describe residual risks and any undesirable side- effects.
Does the clinical evaluation specify the methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and undesirable side-effects?
If relevant, briefly summarise any significant complaint, trends or vigilance issues associated with earlier device iterations, which may be equivalent or similar devices, and explain whether or not they have any impact on the clinical evaluation assessment.
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Non-compliances identified and resolved for this section may be briefly described in this box
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The clinical evaluation plan is:
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Compliant with the applicable requirements of the MDR:
Include any relevant comments
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Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:
Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.
Common specifications, harmonised standards or other solutions applied
Are there common specifications relevant to the device under evaluation?
Have they been complied with?
If not:1
- Explain any deviations and how these might affect the validity of the clinical evaluation and its conclusions, and any equivalence claims.
- Confirm that the manufacturer has adopted solutions that ensure a level of safety and performance that is at least equivalent thereto in accordance with Article 9(3).
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Are there harmonised standards relevant to the clinical evaluation of the device under evaluation?
Have they been applied?
If partially applied add the manufacturers justification and confirm that the manufacturer has adopted solutions that ensure a level of safety and performance required by the Regulation (EU) 2017/745.
If there are deviations explain any deviations and how these might affect the validity of the clinical evaluation and its conclusions, and any equivalence claims.
Is the most up-to-date revision being used by the manufacturer? (state which revision was used)
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Are there other solutions that have been applied?
Describe any standards, guidance or other solutions that have been applied, and the manufacturers justification
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Non-compliances identified and resolved for this section may be briefly described in this box
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