CLINICAL EVALUATION GAP ANALYSIS

Identify clinical evidence gaps before your Notified Body does

Need an independent view of your CER before a submission or audit?

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£3,250 | Written diagnostic within five working days

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A structured review of your clinical evidence, documentation, and remediation priorities, ahead of submission or audit

A Clinical Evaluation Gap Analysis is a structured review of your clinical evidence and associated documentation, designed for manufacturers preparing for a Notified Body submission, a surveillance audit, or both.

We assess your existing clinical data, literature, and technical documentation against MDR Article 61, Annex XIV, and current MDCG guidance, identify gaps across seven review dimensions, and provide a prioritised action plan to address them before review begins.

Trusted by

[Bray Group]
[Caristo Diagnostics]
[C the Signs]
[CooperVision Specialty EyeCare]
[Innovia Medical]
[LifeScan]

What This Service Delivers

  • Clinical Evidence Inventory

    • Complete catalogue of your existing clinical data, literature, PMCF information, and technical documentation.

  • MDR Requirement Mapping

    • A clear view of how your documentation aligns with MDR Annex XIV, MDCG 2020-13, and other relevant guidance.

  • Gap Identification Report

    • Specific deficiencies across seven review dimensions.

A systematic review of your clinical evidence and documentation, with clear identification of gaps and prioritised remediation actions, delivered in 5 working days for a fixed fee of £3,250.

What you will receive:

SciMed consultant reviewing clinical evaluation documentation as part of a gap analysis assessment

The Seven Review Dimensions

1) Literature Coverage

  • Are relevant databases searched (beyond PubMed)?

  • Are search strategies documented and justified?

  • Are key studies for your device type missing?

2) Equivalence Justification (if applicable)

  • Is technical similarity sufficiently demonstrated?

  • Is biological equivalence supported?

  • Is clinical similarity substantiated with evidence?

3) Benefit-Risk Analysis

  • Is the analysis supported by data rather than assertion?

  • Are risks quantified where appropriate?

  • Are benefits contextualised against current benchmarks?

4) State-of-the-Art Comparison

  • Are current clinical benchmarks clearly defined?

  • Is device performance contextualised appropriately?

  • Is methodology transparent and reproducible?

5) PMCF Integration

  • Does the PMCF Plan address identified gaps?

  • Are data collection methods defined?

  • Is there a clear plan for ongoing evidence generation?

6) Risk Management Alignment

  • Is there alignment with ISO 14971 risk analysis?

  • Are clinical risks clearly identified and mitigated?

  • Is residual risk justified by clinical benefit?

7) Documentation

  • Are claims appropriately referenced?

  • Is methodology transparent?

  • Are conclusions supported by evidence?

Additional Outputs

  • Prioritised Remediation Plan

    • Which gaps are likely to affect submission or audit readiness, and which can be addressed later.

  • Indicative Remediation Effort

    • Likely effort, dependencies, and sequencing for each major gap.

  • Immediate Actions vs Longer-Term Remediation

    • What can be addressed quickly versus what requires strategic planning.

Want to understand where the main risks sit before your next submission or audit?

Reserve Your Gap Analysis

Fixed fee £3,250. Delivered in five working days. NDA in place before document sharing.

We can review your current documentation set and show you where evidence, alignment, or justification may need strengthening before review begins.

Not Ready Yet? Start with a Self-Audit

Use our Clinical Evaluation Audit-Readiness Checklist to identify common weaknesses in CER structure, evidence coverage, and PMCF alignment before your next submission or audit cycle.

Why Pre-Submission and Pre-Audit Gap Analysis Matters

The pattern is familiar, whether the trigger is an upcoming submission or a Notified Body audit on the calendar: documentation is reviewed internally, the review is treated as complete, and the cross-document coherence questions only surface when an external reviewer starts pulling threads.

Internally, teams describe the same frustration. They have the other EU MDR requirements in place, but the clinical evaluation remains the most frustrating piece, particularly justifying state-of-the-art for low-risk or legacy devices, and managing the moving target of when the CER must be updated against new PSUR or PMCF data.

Typical findings may include:

  • Literature searches that are incomplete or insufficiently justified

  • Equivalence arguments that have become nearly impossible to support under MDR without competitor data

  • Benefit-risk assessments lacking quantitative support

  • PMCF plans that do not address known evidence gaps

  • State-of-the-art sections without clear methodology

  • Cross-document inconsistencies between the CER, PMCF Plan, PSUR, and complaints data

The impact is usually wider than the finding itself:

  • Additional review cycles

  • Avoidable consultancy costs,

  • Delayed market access

  • Internal pressure on regulatory and commercial timelines, and

  • Audit findings that compound the next surveillance cycle.

In many cases, these gaps could have been identified before the review window through a more structured internal assessment. This often happens because internal reviews focus on document completion rather than whether the evidence package would withstand external scrutiny.

How SciMed Supports Submission & Audit Readiness

We review your clinical evaluation with the level of scrutiny typically applied during Notified Body conformity assessment, with the aim of identifying and prioritising issues before submission or audit.

Our Approach:

  • Document Collection

    • CER, CEP, PMCF Plan, State of the Art, technical documentation, and risk management file shared under NDA.

  • Systematic Gap Review

    • Assessment against MDR Article 61, Annex XIV, and current MDCG guidance (including MDCG 2020-13).

  • Evidence Quality Assessment

    • Evaluation of relevance, strength, and completeness of clinical data.

  • Regulatory Benchmarking

    • Assessment against current Notified Body expectations and common evidence patterns.

    Gap Report Delivery

    • Written findings with severity classification, audit-finding likelihood ratings, and remediation recommendations.

    Remediation Workshop

    • 30-minute walk-through of findings, with prioritisation and next-step planning.

    Optional Remediation Support

    • Scoped follow-on engagement if you'd rather SciMed lead the remediation than hand the roadmap back to your team.

Why Companies use SciMed for Clinical Evaluation Gap Analysis

Example Outcome

In one recent engagement, a client's CER appeared complete at document level, but the underlying evidence package still contained several material weaknesses.

The review identified:

  • Multiple addressable gaps in literature scope, equivalence justification, and PMCF alignment

  • SevSeveral higher-priority issues affecting submission or audit readiness

  • Strategic decisions required regarding evidence generation versus claim positioning

Addressing these issues before submission or audit allowed remediation to be planned, sequenced, and executed without time pressure.

  • Notified Body-Informed Review

    • Focus on the evidence, logic, traceability, and justification reviewers actually scrutinise, not on marketing-claim language.

  • Actionable Findings

    • Each issue is linked to a practical next step, with written rationale your QA team can act on.

  • Risk-Based Prioritisation

    • Focus on issues that affect approval and audit findings, not cosmetic improvements or compliance theatre.

  • Proportionate Recommendations

    • Focus on material weaknesses, not the unnecessary rework that comes from one-size-fits-all template solutions.

This service is designed to reduce avoidable submission and audit risk by identifying evidence and documentation issues before they affect review timelines.

What sets us apart:

Not ready to reserve yet?

If you'd like to talk through your situation before committing, book a free 30-minute Gap Analysis Consultation. We'll look at your current position and tell you honestly whether the Gap Analysis is the right next step.

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