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Clinical 中文

Medical Writing

Medical device clinical evaluation

A clinical evaluation report (CER) brings together and evaluates the relevant clinical evidence for a device. Post-market clinical follow-up (PMCF) continuously adds post-market clinical information and feeds back into clinical evaluation. These documents are intended for the client's clinical, medical and regulatory teams and relevant reviewers or assessors.

Service scope
We search, evaluate and write up clinical evidence for device documents such as CER and PMCF, with attention to consistency between images, results and interpretation. We also prepare clinical evaluation materials for registration in China.
Submit a medical writing requestDeliverables

CER evaluators are appointed by the client and sign the evaluation report; we undertake evidence searches, appraisal and writing. Responsibility for document sign-off and submission rests with the client.

01 · Deliverables

Linking clinical evidence, intended purpose and evaluation conclusions

Deliverables

Medical device clinical evaluation

Service scope
We search, evaluate and write up clinical evidence for device documents such as CER and PMCF, with attention to consistency between images, results and interpretation. We also prepare clinical evaluation materials for registration in China.
Deliverables

CEP.

Literature search protocol and search report.

CER.

PMCF plan and PMCF evaluation report.

SSCP for implantable and class III devices within the scope of MDR Article 32, excluding custom-made or investigational devices.

Clinical evaluation materials for registration in China.

Specifications and timeline
EU documents are checked against MDR Article 61 and Annex XIV, with CER structure informed by MEDDEV 2.7/1 rev.4. PMCF plans and evaluation reports use the MDCG 2020-7 and MDCG 2020-8 templates respectively; SSCP follows MDR Article 32 and MDCG 2019-9. Clinical evaluation materials for registration in China follow the NMPA Technical Guidelines for Clinical Evaluation of Medical Devices (医疗器械临床评价技术指导原则) (2021). Timelines are confirmed for each project.
Pricing basis
We first issue a requirement confirmation form, followed by an itemised quotation.

We undertake evidence searches, appraisal and writing; CER evaluators are appointed by the client and sign the evaluation report.

The target market, available clinical evidence and proposed deliverables are defined in the requirement confirmation form.

02 · Content structure

CER structure and PMCF updates

Figure 1　CER and PMCF update relationships · Illustrative structureEvaluation scopeSearch and appraisalCEREvidence gapsPMCF planConduct activitiesRoles agreed per projectPMCF eval. reportUpdate CERFigure 1　CER and PMCF update relationships · Illustrative structureEvaluation scopeSearch and appraisalCEREvidence gapsPMCF planConduct activitiesRoles agreed per projectPMCF eval. reportUpdate CERPMCF evaluation → CER update
Figure 1CER and PMCF update relationshipsIllustrative structure
Figure caption

Illustrative document relationships; this does not indicate that clinical follow-up has been conducted or certification obtained.

Device and evaluation scope
Define the device description, intended purpose, target population and evaluation questions.
Clinical background and evidence sources
Describe current clinical practice and how relevant evidence is identified, recording the search and selection process.
Evidence appraisal and analysis
Evaluate relevance, methodological quality and the degree of support provided; literature volume must not replace judgement of clinical evidence sufficiency.
Conclusions and evidence gaps
Describe how the evidence supports safety, clinical performance and benefit-risk judgements, and its limitations.
Updates and supporting materials
List subsequent follow-up needs, references, evaluator information and necessary appendices.

Evidence gaps identified in clinical evaluation can inform the PMCF plan. After evaluation, PMCF results feed back into the CER and relevant risk management materials. Plans, implementation results and evaluation conclusions are recorded separately.

03 · Work steps

Evidence searches, appraisal and document preparation

  1. Target market and material scope

    Define document use, intended purpose, target population, product materials and existing evaluation documents, confirming applicable requirements for the target market.

  2. Evaluation planning and searches

    Develop a clinical evaluation plan (CEP) and search protocol around the evaluation questions, retaining search strategies, selection criteria and evidence sources.

  3. Material appraisal and analysis

    Distinguish direct clinical evidence from other relevant materials and their limitations, checking the relevance of study populations and device characteristics to the intended purpose.

  4. Check report and related documents

    Check consistency across the CER, PMCF documents, product description and related clinical conclusions, recording evidence gaps and unresolved matters.

  5. Review and sign-off

    Resolve review comments; the CER evaluators appointed by the client sign the evaluation report.

04 · Standards and guidance

EU and Chinese standards and guidance

The target market determines the document framework. EU documents and Chinese registration materials must be checked separately against applicable requirements; translation alone cannot make them interchangeable.

EU and Chinese standards and guidance
Standard and scopeVersion, content and purpose
Clinical evaluation methods and reportingMEDDEV 2.7/1 rev.4, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies (June 2016): section 6.4 concerns evaluators, sections 7–11 cover evaluation stages, and Appendix A9 provides an example report contents list. This document originates from the former directive framework and serves as a methodological and structural reference; it cannot replace the MDR.Full guideline.
Notified body assessment perspectiveThe Medical Device Coordination Group (MDCG) 2020-13 Clinical Evaluation Assessment Report Template (July 2020) is for notified bodies' clinical evaluation assessment reports. Section C covers the device and evaluation plan; section D covers clinical literature review; section F covers post-market surveillance, PMCF and update plans. We use its assessment priorities for self-checks; it must not be described as a manufacturer's CER template.Full template.
PMCF documentsMDCG 2020-7, PMCF Plan Template, and MDCG 2020-8, PMCF Evaluation Report Template (both April 2020), are for plans and evaluation reports respectively; section C records planned activities and actual results respectively.Plan template, Evaluation report template.
SSCPMDR Article 32 and section 5 of the content guidance in MDCG 2019-9 Rev.1, Summary of Safety and Clinical Performance (March 2022), concern the summary of clinical evaluation and PMCF; the annex provides an SSCP template.European Commission guidance directory.

05 · Samples and examples

Example presentation of evidence searches

The example shows literature selection and does not indicate that clinical evidence meets registration requirements.

View samples and examples
Figure 2　Device CER literature search and appraisal process · Illustrative data
Figure 2Device CER literature search and appraisal processIllustrative data
Figure caption

The process and numbers are simulated. Databases identify 800 records and registers 100; 163 duplicates and 15 records removed for other reasons leave 722 records for screening, of which 560 are excluded. Full texts are sought for 162 reports, with 10 not retrieved; 152 full texts are assessed, with 44, 32 and 28 excluded for incompatible populations, outcomes and designs respectively. Finally, 48 reports from 41 studies are included. The flow follows the databases-and-registers pathway for new systematic reviews in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020. It does not indicate completion of a real CER search or quality appraisal.

06 · Frequently asked questions

Frequently asked questions

CER evaluators and sign-off

CER evaluators are appointed by the client and sign the evaluation report; we undertake evidence searches, appraisal and writing. Evaluator competence must be checked against applicable requirements; the manuscript cannot replace evidence of qualifications.

Registration materials for China

We prepare clinical evaluation materials for registration in China. Documents follow applicable Chinese requirements; a Chinese translation of an EU CER does not replace Chinese evaluation materials.

PMCF plan and evaluation report

The plan describes proposed activities; the evaluation report describes information actually obtained and the evaluation results. Activities not yet conducted must not be written as completed results. Writing services do not automatically include on-site conduct of follow-up activities.

Literature volume and evidence sufficiency

Search and selection counts describe only the process of identifying materials. Clinical evaluation also requires judgement of evidence quality, relevance and support for the intended purpose.

Get started · Submit a request

Submit a medical writing request

Please provide the target market, device category and intended purpose, existing clinical evidence and evaluation documents, proposed deliverables, evaluator arrangements and timing requirements.

Submit a medical writing requestWe first issue a requirement confirmation form, followed by an itemised quotation and schedule. Reply within 24 hours (business days first). · contact@yantohealth.cn
View engagement boundaries

This section describes our services. It does not concern any specific medicinal product and does not constitute drug advertising. Final deliverables, timelines, prices and each party's obligations are governed by the contract signed by both parties.

Writing and statistical support for research publications follows the recommendations of the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice 2022. Our contribution is disclosed in the acknowledgements in line with ICMJE and GPP 2022; we are not listed as authors. Funding sources are also disclosed truthfully. We do not promise publication outcomes.