Structuring and drafting the clinical evaluation report

A clinical evaluation report takes its structure from the guidance it is written to. Drafting it rests on the inputs and responsibilities settled before writing begins, follows the contents list the guidance indicates, opens with a summary written last, and states in its scope what the evaluation is for and which documents it draws on.

Guidance behind the report

In 2017, MEDDEV 2.7/1 Rev. 4 (June 2016) was the guideline that determined the structure and content of the clinical evaluation report. ^{1, 2}

In 2019, one device writer advised a writer new to device writing who has no template in place to use ISO 14155 as guidance, together with the relevant revision of MEDDEV 2.7, which also gives some indications for the structure of the report. ^{3, 4}

Asked for a freely usable reference form, another device writer pointed to the structure that MEDDEV 2.7/1 revision 4 provides or recommends for the report: its high-level headings and subheadings and what the content under them should be. ^{5, 6} The guidance is freely available on the internet. ⁶ The same writer reported that some device-writing colleagues were working together on a clinical evaluation report template, which they hoped to share with colleagues and, if feasible, with the whole industry. ⁷

As of 2022, the guidance documents to be considered during the clinical evaluation process are: ⁸

• Article 61 of the EU MDR 2017/745, on clinical evaluation and the need for clinical investigations
• MDCG 2019-9, on the summary of safety and clinical performance for class III and implantable devices, which provides its definition and templates
• MDCG 2019-11, which addresses device classification and includes software as a medical device
• MDCG 2020-5, on equivalence in clinical evaluations, which defines the technical, biological and clinical requirements to be addressed when claiming equivalence to an already established device
• MDCG 2020-6, on sufficient clinical evidence for legacy devices, which defines sufficient clinical data for legacy devices and well-established technologies, gives a hierarchy of clinical evidence in its Appendix III, and defines terms such as indication, intended purpose and state of the art
• MDCG 2020-7 and MDCG 2020-8, which provide templates for the post-market clinical follow-up plan and report
• MDCG 2020-13, the clinical evaluation assessment report template, which is aimed at notified bodies but which manufacturers and writers should be familiar with, because it defines the minimum information notified bodies will seek; it also contains information on best practices for conducting literature searches
• MDCG 2021-24, guidance on the classification of medical devices
• the International Medical Device Regulators Forum, which provides working groups on specific topics, support for documents, and consultations

⁸

Inputs and responsibilities

The medical writer's role is to collect, assimilate and objectively present data about the device in accordance with the requirements of MEDDEV 2.7/1. ⁹ That requires input from other experts, such as the manufacturer for technical information about the device, a librarian or information scientist for literature searches, a quality specialist for complaints data, and a safety scientist for post-market surveillance data. ⁹

One device writer advises establishing the inputs before drafting: whether equivalence is being claimed, what clinical data have been generated, and what clinical data come from the literature and who is producing them. ¹⁰ Much of this depends on the device's classification. ¹⁰

For each section of the report, that writer puts together a route map of roles and responsibilities: who is responsible and where the information is coming from. ¹⁰ Once the people are involved, they set very clear timelines and responsibilities, covering comment-resolution meetings in between, what actions people are taking and how they will resolve their comments, and any interactions with the notified body. ^{10, 11}

Table of contents

MEDDEV 2.7/1 Rev. 4 gives some indications for a structure for the report but does not mandate one. ¹² The table of contents that MEDDEV 2.7/1 Rev. 4 proposes in its Section A9 runs: ¹²

1. Summary
2. Scope of the clinical evaluation
3. Clinical background, current knowledge, state of the art
4. Device under evaluation
   • 4.1 Type of evaluation
   • 4.2 Demonstration of equivalence (only if claimed)
   • 4.3 Clinical data generated and held by the manufacturer
   • 4.4 Clinical data from literature
   • 4.5 Summary and appraisal of clinical data
   • 4.6 Analysis of the clinical data
     • 4.6.1 Requirement on safety
     • 4.6.2 Requirement on acceptable benefit/risk profile
     • 4.6.3 Requirement on performance
     • 4.6.4 Requirement on acceptability of side-effects
5. Conclusions
6. Date of the next clinical evaluation
7. Dates and signatures
8. Qualification of the responsible evaluators
9. References

¹²

Some sections contain more or less data depending on the time-point in the product life cycle, such as development, and on what data are available, such as published literature or clinical investigation data. ¹²

It is best to adhere to the MEDDEV table of contents unless the sponsor has a different template: a group of device writers agreed on this in 2018, although they found the structure somewhat inconvenient and several had worked with different tables of contents. ^{13, 14} One device writer's tip is to use the clinical evaluation assessment report checklist to verify that the report contains all the required information. ¹⁵

Summary

Although the summary is the first section to be read, it is the last to be written. ⁹ It should give a succinct overview of the clinical condition and the state of the art, brief details of the subject device and its indication, the conclusions of the evaluation of pre-clinical studies, pre-market clinical investigations, risk management, post-market surveillance and published literature, and the conclusion on the risk-benefit profile. ⁹ It is usually up to two pages long. ⁹

Scope

The scope sets out the objectives of the report, what is included, and which guidelines, standards and reference materials were used. ¹⁶ In 2017 the objective was to support conformity of the device with the essential requirements for safety and performance of the Medical Devices Directive 2007/47/EC, which the Medical Devices Regulation was to supersede. ¹⁶ The scope should state whether the report supports initial CE marking or a CE mark renewal, or was requested by the notified body. ¹⁶

Under MEDDEV 2.7/1 Rev. 4, every report requires the device description, its design features, the intended purpose, warnings and contraindications as the instructions for use give them, the risk management documents, the current knowledge or state of the art, and the data sources, such as in-house reports and published literature. ^{16, 17, 18} A report for a CE-marked device additionally requires relevant changes in design, materials or instructions for use, newly emerged clinical concerns, new post-market surveillance data and post-market surveillance planning; a report for a new device claiming equivalence additionally requires the equivalence data. ^{16, 18, 19}

In 2017 the guidance documents used in addition to MEDDEV 2.7/1 included EN ISO 14155:2011 on the clinical investigation of medical devices for human subjects, EN ISO 14971:2012 on the application of risk management to medical devices, MEDDEV 2.12/2 rev 2 on post-market clinical follow-up, to be superseded by MDR Annex XIV, and NB Med 2.12 Rec 1 on post-marketing surveillance, to be superseded by MDR Annex III. ¹⁸ Depending on the type of device, other guidelines might also be relevant, such as MEDDEV 2.1/6 on the quantification and classification of stand-alone software. ¹⁸ The reference materials used in preparing the report include the instructions for use, the literature review, the clinical investigation reports, the risk management reports and the post-market surveillance reports. ¹⁸