Clinical Evaluation Plan Writing for Medical Device Manufacturers
Pubrica writes clinical evaluation plans (CEPs) for medical device manufacturers, prepared before the clinical evidence is gathered. The plan fixes the intended purpose, clinical claims, state of the art, acceptance criteria and literature method in advance, so that the clinical evaluation is not shaped by the evidence found. Notified bodies review the plan to judge whether the report is credible. Our device clinical evaluation writers deliver a CEP to MDR Annex XIV Part A against which the CER can then be assessed.
- Required by MDR Annex XIV Part A, and assessed as a document in its own right rather than as an introduction to the CER
- Acceptance criteria set before the search runs, defining in advance which benefit-risk profile is acceptable
- Clinical claims listed individually, because every claim you intend to make has to be supported by evidence identified through this plan
- Literature method specified: databases, strategy, appraisal method and weighting, fixed before anything is screened
- Equivalence strategy declared in the plan, where equivalence is claimed, to MDCG 2020-5, with access to the equivalent device’s technical documentation addressed at the outset
Intended purpose and claims fixedIncluded
Acceptance criteria set in advanceIncluded
Literature method specifiedIncluded
Equivalence strategy where claimedIncluded
Plan written after the CERNot recommended
Purpose → claims → criteria → method → CER
- Written before the evidence is reviewed
- Acceptance criteria set in advance
- Every clinical claim listed
- Literature method fixed and reproducible
- Equivalence position assessed
Deliverables
Four Deliverables Included in Every Clinical Evaluation Plan
The plan determines what the CER may conclude, which is why it is written before the report.
Example from a planIntended for the treatment of chronic wounds.Intended for the management of full-thickness diabetic foot ulcers of at least four weeks’ duration in adults, applied by a trained clinician, for up to twelve weeks of continuous use. Each clause excludes literature that would otherwise appear relevant.
Example from acceptance criteriaCriteria written after the evidence is reviewed will always be met by the device. Assessors check for this, and the plan is dated.
Example from a claims tableA marketing claim with no evidence route in the plan is likely to lead to a finding. Removing it at the planning stage avoids this at no cost.
Example from a method sectionA specified method makes the clinical evaluation reproducible, so that an assessor can rerun the search and verify the results.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Regulatory References for Clinical Evaluation Plans
A clinical evaluation plan is a regulatory requirement that contains an evidence-synthesis method.
Medical Device Regulation (the regulation itself)
Article 32 for the SSCP, Articles 83 to 86 for post-market surveillance, Annex I for the general safety and performance requirements, Annex II for technical documentation and Annex XIV for clinical evaluation and PMCF.
Clinical evaluation guidance (June 2016)
The structure notified bodies continue to assess against, read alongside MDCG 2020-13, the assessment template assessors work from.
PRISMA 2020 (literature methodology)
The search and screening method that underpins a clinical or performance evaluation, allowing an assessor to reproduce your literature review.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Responsible Use of AI, with Human Authorship and Traceable Decisions
Regulatory reviewers trace decisions back to evidence and to named individuals. For this reason, source traceability takes priority over speed whenever we use AI tools.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote its own accuracy figure, which would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Clinical Evaluation Plan Writing Process Works
We fix the intended purpose first, because it defines the scope of everything that follows.
Intended Purpose and Claims
We write the intended purpose clause by clause and list every clinical claim with the type of evidence that would support it.
State of the Art and Acceptance Criteria
We establish the current benchmark for the indication and derive acceptance criteria from it before any device evidence is examined.
Method
We specify the literature search strategy, appraisal method and weighting, and declare the equivalence strategy where equivalence is claimed.
Evidence Gaps and PMCF
We identify evidence gaps against the criteria and set out the PMCF activities that will address them, linking the plan to post-market follow-up.
Our Experts
Our Clinical Evaluation Writing Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Three Clinical Evaluation Plan Service Options, Quoted per Project
Cost depends on device class, the breadth of the intended purpose and the number of claims.
Clinical evaluation plan
Before the clinical evaluation starts
Quoted per projectBased on device class and number of claims
Delivery By scope
- ✓Intended purpose written clause by clause
- ✓Clinical claims listed with evidence routes
- ✓State of the art established
- ✓Acceptance criteria derived
- ✓Literature method specified
- ✓Evidence gaps and PMCF linkage
Commissioned before the CER, so that the plan can guide the clinical evaluation.
Deliverables Request a quotePlan and evaluation together
A full clinical evaluation
Quoted per projectBased on class and available evidence
Delivery By scope
- ✓Clinical evaluation plan first
- ✓Literature review to the specified method
- ✓Appraisal against the stated criteria
- ✓CER written to MDCG 2020-13 structure
- ✓PMCF plan drafted from the gaps
Commissioning both together usually costs less and avoids inconsistencies between plan and report, which assessors check for.
Deliverables Request a quotePlan review
A plan written elsewhere
Quoted per projectBased on plan length and device class
Delivery By scope
- ✓Assessed against Annex XIV Part A
- ✓Acceptance criteria checked for circular reasoning
- ✓Claims checked against evidence routes
- ✓Literature method tested for reproducibility
- ✓Findings reported by severity
A confidential review that identifies issues before notified body assessment.
Deliverables Request a quoteSend your intended purpose statement for a free assessment of which clauses define your evidence base and which make it wider than necessary.
FAQs
Clinical Evaluation Plan FAQs
If your question is not answered here, ask an expert. No quote is required.
A plan can be produced afterwards, but assessors will recognise it as such. The plan is dated and assessed separately, and its purpose is to constrain the evaluation in advance.
Acceptance criteria that exactly match the results obtained indicate a plan written after the evaluation, and assessors recognise this.
It must be specific enough to define the scope of the literature. Indication, population, condition, body part, user, environment and contact duration each determine which evidence applies.
A broad intended purpose may seem commercially safer, but it considerably increases the evidence burden, because all of it must be supported.
No. Under MDR, equivalence is harder to claim than before. MDCG 2020-5 sets the technical, biological and clinical characteristics that must match, and you generally need contractual access to the equivalent device’s technical documentation.
Where equivalence is claimed, it is declared in the plan with the access position stated, so that any access problem is identified before the literature review.
Yes. The plan is updated on the clinical evaluation cycle together with the report, because a report updated against an outdated plan is inconsistent.
Where PMCF findings change the evidence gaps, the plan is updated to reflect them.
Related Services
Related Clinical Evaluation Services
The plan begins the clinical evaluation cycle, and PMCF work completes it.
1WHAT IT GOVERNSdownstream
Clinical evaluation reportWritten against this plan. State-of-the-art reviewThe benchmark the criteria come from.2THE POST-MARKET SIDEpost-market follow-up
PMCF plan and reportClosing the gaps this plan names. PMS and device PSURArticles 83 to 86.3THE REST OF THE FILEalongside
Device risk managementISO 14971 file. GSPR checklistAnnex I, evidenced line by line.Request a Free Assessment of Your Intended Purpose Statement
We show which clauses define your evidence base and which widen it unnecessarily.