CLINICAL EVALUATION GAP ANALYSIS CONSULTATION
Find Out Whether Your Clinical Evidence Is Ready for Submission
Most manufacturers we speak to are not starting from zero. They have documentation. They have a Clinical Evaluation Report, or at least a working draft. They have invested months, sometimes longer, in building an evidence package they believe is defensible.
The uncertainty is whether it will hold up under Notified Body review.
That uncertainty has consequences. Proceeding to submission with unresolved evidence gaps often leads to delays, additional queries, and avoidable remediation work.
This consultation is designed to give you an earlier, independent view..
What This Consultation Is
This is a working conversation, not a report or a formal audit.
We use the session to look at your specific device, your documentation structure, and your current regulatory position. From there, we can indicate where your evidence package is likely to hold up under external review, and where further scrutiny may be expected.
During the consultation, we will:
Review your current clinical evaluation approach and documentation structure against MDR or IVDR expectations
Identify areas where evidence, methodology, or alignment may be insufficient
Highlight the gaps most likely to affect submission readiness or trigger Notified Body questions
Outline what a proportionate remediation approach may involve at your current stage
Advise honestly whether a full Clinical Evaluation Gap Analysis would add value at this point
The aim is to give you a clear picture of where you stand, so you can make informed decisions about what to do next.
This session does not involve a detailed document review. Where deeper assessment is required, we will recommend a structured Clinical Evaluation Gap Analysis.
Who Will Find This Most Useful
You do not need a finalised evidence package to benefit from this session. You do need to be at a stage where understanding your clinical evidence risks actually matters to your timeline.
This consultation is particularly relevant if you are:
Preparing for an MDR submission
…and want an independent check before you proceed
Finalising a Clinical Evaluation Report (CER)
…and unsure whether the evidence base is sufficient
Uncertain about your clinical evidence package
…and if it would withstand external review
Working to align PMCF
…with risk management, and clinical evaluation documentation before submission
Have, or anticipate Notified Body questions
…about your clinical evidence, and need to respond
This is most valuable when your submission timeline depends on the quality and completeness of your clinical evidence.
What to Bring
The session is most productive when we can discuss your documentation and current approach. If you have the following available, bring what you can:
Your Clinical Evaluation Report (CER) or current draft
Clinical Evaluation Plan (CEP) or equivalent planning document
PMCF Plan
A brief description of the device and its intended use
Your current regulatory stage, for example pre-submission or under active review
If some of these are not yet in place, that is useful information in itself. We can still use the session to work through your current approach and identify where the priorities lie.
What You Leave With
By the end of the consultation, you will have a clearer view of your current position.
Specifically, you will have:
A view of whether your documentation is likely to support submission as it currently stands
An understanding of where the most significant evidence gaps sit and which carry the most submission risk
A clear sense of which issues require immediate attention and which can be addressed progressively
An outline of appropriate next steps, whether that is a structured gap analysis, targeted remediation, or confirmation that your documentation is in good shape
If your clinical evidence package is already well aligned, we will confirm that clearly. This session is about accuracy, not creating work.
Where This Sits in Your Submission Strategy
Producing documentation is rarely the primary challenge. What is harder is knowing whether the underlying clinical evidence will survive the scrutiny of an experienced Notified Body reviewer.
This consultation gives you an independent, structured view of that question before you commit further time and resource to submission or remediation. It is designed to sit at the point where that clarity has the most commercial and regulatory value.
Discuss your Clinical Evaluation Gap Analysis
Select a time to discuss your current clinical evidence position
A Note on Fit
SciMed works with manufacturers where clinical evidence strategy has a direct bearing on submission timelines and market access. That is where we can add the most value.
If your documentation is already well aligned, we will confirm that clearly. If gaps exist, we will focus on the ones that materially affect your path to approval. We do not flag issues for the sake of it, and we do not recommend work that your submission does not need.
Not Ready for a Consultation Yet?
If you want to build a clearer picture before we speak, our Clinical Evidence Self-Audit gives you a structured starting point.
It is a practical checklist covering common gaps across literature coverage, equivalence, PMCF alignment, and documentation quality. Many manufacturers use it to orient themselves before a consultation, or to decide whether one is the right next step.